On Medical Devices And On The Change Of The Administrative Fees.

Original Language Title: o zdravotnických prostředcích a o změně z. o správních poplatcích

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=82930&nr=268~2F2014~20Sb.&ft=txt

268/2014 Sb.



LAW



of 22 March. October 2014



on medical devices and on the amendment of Act No 634/2004 Coll., on

administrative fees, as amended



Parliament has passed the following Act of the Czech Republic:



PART THE FIRST



MEDICAL DEVICES



TITLE I OF THE



INTRODUCTORY PROVISIONS



§ 1



The subject of the edit



This law incorporates the relevant provisions of the European Union (hereinafter referred to as

"The Union") ^ 1) and governs the treatment of medical devices and their

accessories.



The basic provisions and definition of terms



§ 2



(1) medical device means any instrument, apparatus, appliance,

software, including the software intended by its manufacturer

the specific use for diagnostic or therapeutic purposes and

necessary for the correct use of the medical device, material

or other object, specified by the manufacturer for use in humans for the purpose of



a) diagnosis, prevention, monitoring, treatment or alleviation of

disease,



b) diagnosis, monitoring, treatment, alleviation of or compensation for

injury or disability,



(c)), investigation, replacement or modification of the Anatomy or

physiological process, or



(d)) control of conception,



which is below its principal intended action in or on the human body

its pharmacological, immunological or metabolic effect;

However, their functionality can be supported by such effects.



(2) when the general definition in paragraph 1 is a medical

means, in particular,



and) active implantable medical device,



(b)) in vitro diagnostic medical device,



(c)) individually made medical device



(d)) to submit product pharmaceuticals, with the exception of the product placed on the market

so that the medical device and the medicinal product form a single integral

the product which is intended exclusively for single use in this combination; such

the product is considered to be a medicinal product,



(e)), which contains the product as an integral part, a substance which,

If used separately, may be considered to be a medicinal product, and in the

If its action is only an additional effect to the effect

medical device, and



(f)), which contains the product as an integral part, a substance which,

If used separately, may be considered to be a medicinal ingredient

product or a medicinal product derived from human blood or human

plasma, and that in the event that its action is only an additional

effect to the effect of the medical device.



(3) the medical device is not



and) the medicinal product,



(b)), human blood and blood product made from human plasma, blood cell

of human origin and means that contains, at the time of their placing on the market

such a product of blood, blood plasma or cells, with the exception of the product

According to § 2 (2). 2 (a). (f)),



(c)), tissue or cell transplant of human origin, a product from them

derived and product containing the tissue or cell of human origin, with the

the exception of the products referred to in section 2 (2). 2 (a). (f)),



(d)) the transplant, tissue, or cells of animal origin, with the exception of

medical device manufactured utilizing animal tissues

or inanimate product derived from animal tissue,



e) dietary supplement



f) cosmetic and



(g)) the biocidal product.



(4) the active medical device means any medical

resource, which is dependent on a source of electrical power or other

the energy that is directly delivered to the human body or gravity.



(5) an active implantable medical device means the active

medical device intended for total or partial introduction into

the human body, which is to remain in place after the introduction. Accessories

the active implantable medical device is considered to be his

part of the.



(6) in vitro Diagnostic medical device means a

a medical device which is a reagent, reagent product,

Calibrator, control material, Kit, instrument, apparatus,

a device or system whether used alone or in combination, which

It is intended by the manufacturer to be used in vitro for the examination of samples, including

blood and tissue donations, derived from the human body, solely or principally

in order to ensure that information concerning a physiological or pathological state,

congenital anomaly, to determine the safety and compatibility with potential

the recipient, or to monitor therapeutic measures. For medical

in vitro means the container vacuum or other type of

specifically intended by the manufacturer for the primary storage and preservation of samples

derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not medical

in vitro means, if these products are not in terms of their

the characteristics by the manufacturer specifically for the use of in vitro.



(7) medical device for self-testing means the diagnostic

in vitro medical device intended by the manufacturer for use in

the domestic environment by a person who does not need to be a medical professional.



§ 3



(1) the Individually made medical device means a

medical device intended only for a particular patient,

If it is specially made according to individual design characteristics

implementation of the proposed medical professional with the appropriate

Professional and specialized competence. Proprietary medical

a resource that requires modification in order to meet the specific requirements of

a qualified healthcare professional, individually made

a medical device shall not be considered.



(2) a medical device intended for clinical test means

medical device intended for use by a qualified medical

a worker solely for testing your own effectiveness and safety in the

during clinical investigations in an adequate human equivalent

clinical environment.



(3) a medical device intended for performance evaluation

eligibility means the in vitro diagnostic medical device

specified by the manufacturer exclusively for one or more evaluation studies

custom performance carried out in clinical laboratories out

the premises of the manufacturer.



(4) medical device for single use means medical

a resource that is intended for single use only in the case

one patient.



(5) Facilities medical device means a subject that

It is not a medical device, but is intended for use by the manufacturer

only together with a medical device to enable the use of

This medical device in accordance with its intended purpose.

Accessories to in vitro diagnostic medical device are not

invasive sampling resources and resources used directly to a human

the body for the purpose of obtaining the sample.



(6) a variant of the medical device means a closer destination

a specific model or the packaging of the medical device. Individual

medical device variants differ mainly in size, the number of

the pieces in the packaging, colour or a source of power. Individual

variants of the medical device must be the same in your business

the name of the specified purpose, risk class, material composition and production

process.



§ 4



(1) the treatment of a medical device shall mean



and production including conformity assessment),



(b) the placing on the market),



(c)) the importation,



d) distribution,



e) commissioning,



(f)), issue



(g)),



(h)) the use of in the provision of health services,



I) service and



j) removal

.



(2) the placing on the market ' means the first delivery of the medical device

other than a device intended for clinical test or performance evaluation

competence with the intention of distribution or use on the market

the Member States of the Union, the States that make up the European economic area,

Switzerland and Turkey (hereinafter referred to as "Member State"), regardless of whether it is

new or fully recovered.



(3) Importation means placing the medical device on the market, if

the picture was taken outside the territory of the Member States.



(4) the distribution of the means of delivery of the medical device on the market, if

was taken on the territory of the Member States; distribution is not

the provision of the medical device to the consumer, which

does not process or through does not provide services for third parties.



(5) the putting into service ' means the moment in which the medical

a resource for the first time ready to use for the intended purpose in the territory

of the Member States. For the active implantable medical device

this moment means its provision of healthcare worker to

implantation.



(6) the conformity Assessment means the process carried out in accordance with other legal

rules relating to technical requirements on products.



(7) to treat medical device, with the exception of treatment by

paragraph 1 (b). and) only if the medical

resource evaluated by consensus.



§ 5



For the purposes of this Act, means the



and the issue of the provision of medical device) written on the
medical prescription to the patient výdejcem; part of the issue is the provision of

information necessary for the correct and safe use and basic maintenance

a copy of the medical device,



(b) the provision of medical device sales) to the user, and even

shipping way, unless it is an issue,



(c) by the manufacturer to ensure that the person) the design, manufacture, packaging and labelling of

medical device before it is placed on the market under his own

the name, business name or the name, regardless of whether these

the activities carried out by itself or through a third person; the obligations of the

the manufacturer shall also apply to a person who assembles, packages,

renewed or indicates one or more ready-made products or

attaches the specified purpose, with the intention to give medical device on the market

under his own name,



d) authorized representative a person established in a Member State, which is

the manufacturer expressly empowered to act for him and that may be in its

addressed by the authorities of the Member States with regard

the obligations of the manufacturer,



e) importer a person established in a Member State, which shall indicate the medical

resource on the market, if it was taken outside the territory of the Member States,



f) Distributor person in the supply chain, other than the manufacturer and

the importer, which supplies the market a medical device, which took on

the territory of the Member States,



(g) a person operating a pharmacy) výdejcem, medical dispensary

resources, or the eye's optics; výdejcem medical device fully

or partly paid from public health insurance can also be

another person with whom the health insurance company contracted to issue

According to the law governing public health insurance (hereinafter referred to as

"contracting the picking list"),



h) certification, the person who has been notified by the Member State

the authorities of the other Member States of the Union and as the person responsible for the activities

in the conformity assessment of medical devices,



I) intended purpose of use for which the medical device is intended

According to the data provided by the manufacturer on the labelling, in the instructions for use or in the

promotional materials of medical device,



j) withdrawal from market measures whose aim is to prevent

medical device, which is located in the supply chain

comes on the market in the territory of the Czech Republic,



the withdrawal from circulation of the measures), whose objective is the recovery of medical

resource person, that medical device is introduced to the market, she added,

released or sold, in the case of a medical device that has been already

delivered to the user



l) instructions for use of the information provided by the manufacturer in order to inform the

users of the medical device for its safe and sound

the use of the expected efficiency and all necessary preventive

the measures to be taken; the information that must be listed in the

instructions for use, shall lay down the implementing legislation,



m) side effect of unwanted movement phenomenon, which is detected when or

After the use of the medical device in accordance with its intended purpose,



n) mutual influencing the adverse effect they have medical

resources on each other, or adverse effect, which have

medical device and medicinal products or medical device

and other objects, and when you use it, which corresponds to their designated

the purpose of the.



§ 6



Classification of medical devices



(1) medical devices are classified according to the degree of health risk

the appropriate use of medical device



and to risk class I), IIa, IIb or III, in ascending order according to the measure

health risk of the corresponding use of the medical

resource, unless the active implantable medical devices and

in vitro diagnostic medical devices; rules for the classification of

in those classes, lays down implementing legislation,



(b)) in the case of in vitro diagnostic medical devices on

medical devices referred to in list A and list B, on health

devices for self-testing and other diagnostic medical

resources in vitro; lists A and B lays down detailed legal prescription.



(2) medical devices is further determined by the generic groups.

Generic group of medical devices means the file

medical devices having the same or similar intended purpose, or

the common technology, which allows them to classify generically, without

taking account of the properties of a particular medical device. Generic

the Group shall determine the implementing legislation.



TITLE II



THE PERFORMANCE OF STATE ADMINISTRATION



section 7 of the



The competent authorities of the State administration



The State administration under this Act shall be exercised by



and) Ministry of health (hereinafter referred to as "the Ministry") and the



(b)), the State Institute for drug control (hereinafter referred to as "the Institute").



§ 8



The Ministry of



The Ministry in the area of medical devices



and binding opinion) issue on the application for authorization and the person to change,

suspension or cancellation of the authorization under the law governing the technical

the requirements for products, if the authorization relates to activities in the

the conformity assessment of medical devices,



(b)) decides on temporary withdrawal from the market of a medical device, which

is properly CE marked, properly installed, maintained and used by

in accordance with their intended purpose, and yet could endanger the health or

the safety of users and, where applicable, other persons,



(c))



1. cooperation in the field of medical devices with the competent authorities

the Member States and of the Union, including representation in the working groups and

committees of these bodies in the scope of its competence,



2. cooperation with the competent authorities of foreign States, with the world

Health Organization, the public authorities relevant for

safety and health protection at work,



d) cooperates with the Institute, with the Office for technical standardisation,

Metrology and testing, with the notified persons and other

bodies or persons that are involved in the treatment of medical

resources,



e) grants under section 99 and exceptions



f) manages the registry of medical devices.



§ 9



Institute of



The Institute in the field of medical devices



and) decides whether it is a medical device, and classification

medical device, on request or ex officio,



(b)), the manufacturer registers the plenipotentiaries, importers, distributors,

the person conducting the service, clinical trials, and the Contracting Authority notified

of the person,



(c)) notifikuje medical devices,



d) manages the national information system for medical devices,



e) exposes through the registry of medical devices

in a manner enabling remote access



1. information about registered persons working with health

resources,



2. information on the notified medical devices and



3. the information provided by the manufacturer, authorised representative or

distributor in connection with measures to minimize

the recurrence of adverse incidents under section 74, paragraph. 2,



(f)) ensures the transmission of data to the European data bank of health

resources (hereinafter referred to as "Eudamed"),



(g)), and exposes the way enabling the remote access list

the providers of health services, who set up the Ethics Committee under section

16,



(h)) allows the implementation of medical device clinical trials and

grants permission with the changes in the clinical trials of medical documentation

resource,



I) decides on interrupting or stopping clinical trials,



(j))



1. monitoring of adverse events during the investigation carried out by the manufacturers

and if necessary to their investigation and is necessary in a timely fashion

the measures,



2. in the case of the needs of its own investigation of adverse events; When this

the activities of collaborating with the European Commission (hereinafter referred to as "the Commission"), the other

the Member States and the competent authorities of foreign States,



3. the monitoring of the effectiveness of the implementation of the safety remedial measures,



to download) the medical device from the market or from circulation in

the case of unauthorized connections to the CE marking ^ 2)



l) shall decide on the withdrawal of the medical device from the market or from circulation from the

technical or medical reason connected with the characteristics or

the effectiveness of the medical device,



m) is the supervisory body under this Act and in accordance with the law

adjusting the technical requirements on products,



n) issue certificates of free sale according to § 38 paragraph. 2,



about) decided in the first instance in the field of medical devices

administrative offences and the suspension or termination of use

medical device,



p) in the scope of their jurisdiction shall cooperate with the competent authorities of a foreign

States and of the Union,



q) shall inform the Commission and the competent authorities of the Member States of the decisions

pursuant to section 39, together with the statement of the reasons which led to the release of these

the decision, and



r) shall inform the Commission and the competent authorities of the Member States of the measures

taken or contemplated to minimise the recurrence of undesirable

events, including information about these incidents.



TITLE III



THE CLINICAL EVALUATION AND PERFORMANCE EVALUATION



Part 1



General provisions



§ 10
In the case of the medical device is in the process of the assessment of conformity always

performs clinical evaluation or performance evaluation,

unless otherwise provided in this Act.



Part 2



Clinical evaluation



Section 1



The progress of a clinical trial



§ 11



The basic concepts



(1) clinical trial means a process whose purpose is critical

evaluation of the clinical data and demonstrate the safety and efficacy of

an investigational medical device in compliance with the intended purpose of the

provided for by the manufacturer, in normal conditions of use.



(2) clinical data means information about the safety or efficacy,

that result from the use of the medical device.



(3) clinical data are obtained through



and) one or more clinical trials of an investigational medical

resource,



(b)) of one or more clinical trials or other studies reported in the

the literature relating to medical device for which the

the equivalence is demonstrated with the investigational medical device, or



c) published or unpublished professional reports or conclusions about

use in clinical practice of the investigational medical device, or

medical device properly affixed the CE marking, which is

demonstrated the equivalence with the investigational medical device.



(4) Clinical examination means the use of the medical device to

the subject in the process of the systematic testing provider

health services with the aim of



and whether the examinee) demonstrate a medical device is suitable for use

in accordance with its intended purpose, in particular in terms of safety and efficacy,



(b) the effect of the test) to determine the medical resource on the body

the evaluation and



(c)) to specify the side effects of the medical device to be tested and

to assess whether the risks are acceptable.



(5) Multicentrickou clinical examination means the clinical exam

carried out according to a single plan clinical trials on more professional

workplaces more researchers.



§ 12



The implementation of the clinical trial



(1) Clinical trial must include



and clinical data on) the collection of the investigational medical device or

medical device for which equivalence is demonstrated with

investigational medical device,



(b)) a selection of the clinical data, which are relevant from the point of view

demonstrate the safety and efficacy of an investigational medical

resource,



(c) the evaluation of the clinical data) selected in accordance with subparagraph (b)) and



(d)), the final report of the clinical trial.



(2) clinical evaluation performed by the evaluator, which can only be

qualified expert knowledge



and of the investigational medical device) and its use,



(b)) in the field of development of medical devices, including clinical

testing and Biostatistics and



(c)) about the diagnosis and treatment in areas where health care is to be evaluated

the resource is used.



(3) the progress and outcomes of a clinical trial shall be recorded in the

the documentation. This documentation is part of the technical dossier,

medical device, or it must be in the technical documentation

full of links.



(4) a medical device by the manufacturer must be observed following the

clinical evaluation and after the placing on the market. Data collected in the framework of the

This monitoring shall be recorded in the documentation of the clinical trial.

If there is no follow-up after placing the medical device on the

the market by the manufacturer is considered necessary, this decision must be duly

justified and the reasons stated in the documentation.



(5) If, having regard to the special nature of the interaction of the medical

the resource with the human organism, on the intended intended purpose, and claims

the manufacturer is not a clinical trial, the clinical evaluation

does not. The non-clinical evaluation of the manufacturer must be properly

justified on the basis of risk management, with the sufficiency of the proof of

conformity with the essential requirements shall be carried out, the comparative performance evaluation

testing and preclinical evaluation.



(6) in the case of implantable medical device and

medical device risk class III must be clinical

the guest is always carried out in the form of clinical trials of medical

resource, except in justified cases, when you can rely on

the existing clinical data.



Section 2



Clinical test



section 13



The concepts of



(1) a participant in the clinical trials is



and the sponsor clinical trials), which means the person eating

provider of health services the implementation of clinical trials and

ensures the initiation, management, organization, control, or

funding for clinical trials. The sponsor clinical trials must be

established in the territory of a Member State shall grant a power of attorney or a person who

It is established on the territory of a Member State,



(b)), the investigator, which means a health professional with the appropriate

Professional and specialized competence, that is intended by the contracting authority

clinical trials and that ensures the progress of clinical trials carried out on the

one professional workplace,



(c)) in the case of multicenter clinical trials the main investigator, which

means a health professional with relevant professional and

a specialized device, which is intended by the contracting authority of clinical

the tests and who is responsible for the coordination and the progress of multicenter clinical

the tests,



(d)) the other persons involved in the design, approval,

implementation, monitoring, documenting and evaluating clinical trials, and



(e)) the trial subject, which means a natural person who participates in the

clinical trials as the recipient of the action of the tested medical

or resource is included in the control group. Body assessment

can only be a healthy volunteer or the patient.



(2) clinical trial Plan means a document which contains detailed

information about the reasons of the purpose, objectives, procedures, management and monitoring

clinical trials and how to keep track of its progress.



(3) an adverse event shall mean any adverse health

event, unintended disease or damage to health, or unwanted

clinical symptoms including abnormal laboratory findings in subjects

the guest or any other persons, regardless of whether or

the test is not related to a medical device.



(4) a serious adverse event shall mean the untoward event that

caused



and) death,



(b)) serious deterioration in the health status of the subject, which was considered

results in



1. life-threatening illness or injury,



2. the permanent damage to the structure or function of the body,



3. hospitalization or prolongation of hospitalization of the subject,

or



4. the need for the implementation of health performance, in order to avoid life

-threatening disease, health damage, permanent damage to the body

structure or function, or



(c) the risk of fetal death) of the fetus, congenital or damage in broilers

the child at birth.



§ 14



The conditions for the implementation of clinical trials



(1) Clinical trial performed by the investigator and the other persons referred to in paragraph 2

(a). (j)) in compliance with the intended purpose of a medical test

resource and under the conditions laid down by the manufacturer and sponsor of clinical

of the test. These persons are obliged to follow a prearranged

plan for clinical trials. From plan clinical trials may depart in

the case of the critical situation facing the risk to the health of the body

Guest. Such derogation shall be notified to the contracting authority without delay

clinical trials.



(2) Clinical examination can be started only if the



and the sponsor clinical trials) checked the eligibility of the workplace to

the implementation of clinical trials and the workplace is eligible,



(b)) the foreseeable risks and difficulties do not prevail in the expected benefits for the

the trial subject, where appropriate, for the protection of public health,



(c)) the conditions referred to in section 18,



(d)) was obtained the written consent of the Ethics Commission with implementation of clinical

tests focusing on the ethical aspects ^ 3),



(e) the implementation of clinical trials) the Institute has in the case of medical

a resource that is not provided with the CE marking, or that is in the context of the

clinical trials used other than the original intended purpose; This

the condition is considered as fulfilled if the hardly more than 1 year from the date of

the date of the entry into force of the decision on the implementation of the Institute to enable clinical

tests or from the day when 60 days have elapsed from the date of delivery of the request for

authorisation of clinical trials of the Institute in the case that the Institute on request

decided,



(f) determine the clinical trials sponsor) investigator's brochure, in the case of

multicenter clinical trials, also the main investigator,



(g)) was carried out bio-safety test corresponding to the

the current state of scientific knowledge or other test that is

necessary for the intended purpose of authentication and security test

medical device,



(h)) has been established by security-technical safety test

medical device in accordance with the law governing the

safety and health at work and the legislation in the field of

prevention against the occurrence of accidents at work,



I) in the case of examiner, multicenter clinical trials main
the investigator, was informed about the results of the bio-safety

test security-technical certificate produced by the medical

resource, as well as about the potential risks associated with the implementation of clinical

the tests,



j) health professionals, who are involved in the design,

approval, implementation, inspection, documenting and evaluating

clinical trials have the relevant professional and specialized

capacity to fulfil its tasks during the clinical trials,



for all contracts, ensuring proper) the progress of the clinical trials were

concluded in written form and signed by the concerned participants in the clinical

tests and



l) sponsor clinical trials insurance case

damage, personal injury or death, and the indemnity shall be

apply to the whole period of implementation of the clinical trials, and even on the case,

When it will not be possible to prove the fault of a particular person; the scope of the insurance

must correspond to the risks associated with the clinical examination carried out.



(3) If a person is subject to evaluation under 18 years of age, may be

the clinical examination is performed only if the current

knowledge of medical science



and the intended purpose of the tested) is a medical device for the prevention

against serious diseases, diagnosis or the improvement of the serious

the State of health of these subjects and



(b) a clinical test for) the subject of an earlier age of 18

did not yield satisfactory results.



(4) if the guest is subject to pregnant or nursing woman, can be

the clinical examination is performed only if the current

knowledge of medical science



and the intended purpose of the tested) is a medical device for the prevention

against serious diseases, diagnosis or the improvement of the serious

the State of health of pregnant or lactating women or yet unborn

children,



(b)) to perform a clinical examination is associated to the unborn or

breastfed baby with only a slight risk, and



(c) there is a reasonable assumption), that the satisfactory results of the clinical

the test can only be achieved in the case of participation of pregnant or nursing women.



(5) when the guest is subject to the person whose responsibility was limited,

the clinical exam may be performed only if

current knowledge of medical science



and the intended purpose of the tested) is a medical device for the prevention

against serious diseases, diagnosis or the improvement of the serious

the health status of individuals with the same disease or disability,



(b) a clinical test for) the bodies with a different diagnosis or entities with full

svéprávností did not yield satisfactory results and



(c)) to perform a clinical examination is associated to a person with a given health

with only a slight risk status.



(6) the guest shall not be Subject, unless otherwise provided, a person

in the detention, imprisonment or detention or

located in other facilities on the basis of the decision of the Court or the person

that are provided by the health services without its consent.



(7) If a initiated a clinical test on a person who, in the course of the

testing will be taken into custody, imprisonment will

or the performance of security detention, the person must be of clinical

tests ruled out immediately. This does not apply if the end

clinical trials was compromised the health of the subject. In such a

the event will enable the prison service of the Czech Republic to the provider

health services, for which the sponsor's clinical tests ordered

its implementation, clinical exam to complete, which will provide the necessary

synergy.



(8) when performing clinical trials procedures used must be reasonable

the nature of the test device. When the occurrence of unforeseen

or increasing the risks to the subject must be the implementation of clinical

the tests immediately aborted, and the risk cannot be removed, then it must be

clinical examination ended.



(9) the period of implementation of the clinical trials and the frequency of observations shall conform to the

the nature of the test device, its intended purpose,

certified safety, suitability and effectiveness, so as to guarantee the

the validity of the expert conclusions and not overly saturating the body

Guest.



§ 15



Enable interrupt and stop clinical trials



(1) a clinical examination of the medical device, which is not provided with

the CE marking, or that is in the context of clinical trials used other than

the original intended purpose, can be performed only on the basis of the authorisation

Of the Institute. Application for authorisation shall sponsor clinical trials

electronically through the registry of medical devices. In addition to the

the formalities of the application provided for in the administrative procedure is also part of the application

documentation of the clinical trials according to § 21. 1 (a). and), with the exception of

points 1, 2 and 6.



(2) the Institute shall authorize the implementation of the clinical trials, if he does not find the reasons for the

rejection of the application with regard to the protection of public health, threats to

the health of the subject or other public interest.



(3) the Institute shall decide on the request within 60 days from the date of its submission. In

If the Department does not issue a decision within this period, the implementation of

clinical trials has enabled.



(4) if the contracting authority clinical trials, whose implementation was to Institute

enabled, intends to make changes to the conditions of the clinical trials, ask about the Institute

consent to these changes, and will submit a proposal to Institute changes in the

documentation of clinical tests and the written consent of the Ethics Committee with a proposal

changes. Institute of clinical tests to the contracting authority within 30 days whether the changes

agrees. If the Institute does not respond within this period, agrees.



(5) with regard to the protection of public health, threats to the health of the body

the guest or other public interest can Institute an ongoing clinical

the test, whose implementation has enabled, temporarily discontinue or stop.

The appeal against the decision to interrupt or stop the clinical trials

does not have suspensory effect. The Institute shall communicate its decision and the reasons for it without

undue delay to all Member States and the Commission.



The Ethics Committee



section 16 of the



(1) the Ethics Committee means the advisory body to the health provider

the service, whose task is supervision of the clinical tests in the range of

protect the rights and safety of trial subjects with an emphasis on

ethical aspects.



(2) the Ethics Committee gives its written consent to the clinical

tests of medical device and exercises supervision over the course of

from the point of view of safety and preservation of the rights of the subjects. For this

the purpose, in particular, evaluate the professional competence of Examiners, including the

the main investigator, suitability of the selected processes and groups of bodies

the guest, and this independently of the sponsor clinical trials and investigator.



(3) the Ethics Committee is entitled to establish a health services provider,

for which the sponsor's clinical trials ordered her execution. Ethical

the Commission may, on the basis of a written contract concluded with the provider

health services, which it neustavil, to Act also as the Ethics Committee

for this provider of health services. The conditions for the functioning of

the Ethics Commission shall ensure that the provider of health services, which it

established.



(4) the Ethics Committee is made up of medical personnel, and other members,

and must have at least 5 members, an absolute majority of which are

made up of medical personnel. The Chairman and other members of the Ethics Commission

appoints and replaces the statutory authority of the provider of health services.

Members of the Ethics Committee may only be natural persons who are not

convicted of committing an intentional crime and that the

the providers of health services shall submit to the



and an extract from the criminal record),



(b)) the written consent of the membership in the Ethics Committee,



(c)) that the affidavit to the subject of clinical trials do not have any

the personal relationship, which could cause a conflict of interest and its eventual emergence in

the time of your membership in the Ethics Commission shall notify the provider of the

health services, and



d) written consent to the fact that they will maintain the confidentiality of any

the facts that are brought in connection with his membership in the ethics

to the Commission.



(5) the Ethics Commission are oral and public. The vote of the ethical

the Commission is the public. Each Member shall have 1 vote. The Ethics Committee shall act by a

by an absolute majority of the votes of all members. When a tie is decided by the

the voice of the President.



(6) the provider of health services announces the Institute



and the establishment of the Commission, including ethical) its composition, and within 30 days from the date of

the establishment of, and



(b) the abolition of the ethical Commission), and that without delay.



§ 17



(1) the contracting authority is obliged to clinical trials relevant Ethics Commission

in writing of the intention to carry out clinical exam. Together with the notice

shall submit documentation to the clinical trials referred to in section 21 (a). and)

except for points 5 and 6. The Ethics Committee by written consent or

disagreement with the implementation of clinical trials within 60 days from the date of delivery of the

the notification. In this time period is not counted from the date of request

the missing documents by an Ethics Committee to the date of their receipt by the contracting authority.



(2) If it is necessary to change the conditions of the clinical tests of approved ethical

the Commission shall request the sponsor clinical trials appropriate ethical Commission of the
written consent to changes in the conditions of clinical trials, with submission of the

the Ethics Commission a proposal on the changes in the documentation of the clinical trials.



(3) the Ethics Committee revokes in writing its consent with the implementation of clinical

tests if a) there are new facts negatively

affecting the security of the subjects in the case that these

the fact cannot be immediately removed, or (b)) the sponsor clinical trials,

the investigator or the investigator breaks the serious way their basic

the obligations laid down in sections 19 and 20.



(4) the provider of health services for a period of at least 15 years from the date of

cancellation of the Ethics Commission, which has set up, keeps the minutes of meetings of the ethical

the Commission, reports and correspondence relating to clinical trials, the list of

members of the Ethics Committee, including putting their professional qualifications, and

all of its updates.



(5) If in the case of cancellation of the Ethics Commission, in the course of clinical trials

its activity does not assume the other Ethics Committee, approval of the Ethics Committee, with

the implementation of the clinical trials shall terminate upon cancellation

the Ethics Commission.



section 18



Informed consent



(1) informed consent for participation in a clinical test (hereinafter referred to as

"informed consent") means voluntary and demonstrable representation of

the will of the people, which has become the subject of evaluation, where applicable, its

legal representative or guardian, undergo a clinical test,

a visible signature of the subject, or his legal representative

or guardian.



(2) informed consent must be granted in written form before the start of

clinical trials, unless otherwise specified. In the case that it is

informed consent has been revoked in the course of clinical trials, must be

evaluation of the clinical trial subject.



(3) a person who has a State body evaluation, the investigator must be

properly informed about the conditions under which a clinical exam

carried out, as well as about the risks of the subjugation of the clinical test,

as well as from any speeches of clinical trials, for the body

evaluation of the result.



(4) in the event that there are any new information relevant to the remaining

the subject in the ongoing clinical test, the body must be

Guest investigator immediately informed about these facts. About this

fact, draw up additional informed consent, where applicable,

the appeal of informed consent.



(5) lessons learned according to paragraphs 3 and 4 shall be made in writing, clearly

and in a language that the subject means. The lesson is part of the

informed consent and must contain the



and clinical test information), including the definition of objectives,



(b)) the expected duration of clinical trials and estimated time

the participation of the subject to the clinical test,



(c) the identification and description of the test), medical device,



(d) the list of health services) that will be on the subject

carried out,



e) information on the possible contribution of the clinical trial subject tests,



(f)) for information about foreseeable risks and possible problems associated with the

by subjecting the clinical test,



g) information about other treatment options or diagnosis,



(h) the processing of information) of the personal data of the subject,

including information about the security of their confidentiality,



I) the rights and obligations of the subject, including



1. the rights, at any time to withdraw from the clinical trial and the right to information about the

the way the performance of clinical trials and about the health risks of this

speeches and



2. the right to compensation of damages in case of personal injury or

the death of the subject as a result of participation in a clinical test.



(6) if it is possible to determine the minor's opinion, which is not fully

svéprávná, for possible involvement in the clinical test. If it is reasonable

intellectual and volitional maturity this minors corresponding to its

age, can grant informed consent of that person. The investigator of the

the latter opinion, or the granting of informed consent of a minor

without undue delay, inform the person of its legal representative. To

medical records held by the minor to the person recorded identified

the opinion of this person or the reason for which this could not be detected.



(7) if the body of the person with a limited evaluation of the svéprávností, the

paragraph 6, by analogy with the fact that is does not reflect her age and about detected

the opinion and the granting of informed consent that person shall inform the

guardian.



(8) when the guest is not a body with regard to your health

able to give informed consent prior to the start of clinical trials,

that points to his direct benefit, it shall provide written consent after

When will be acquainted with the nature, significance, implications and risks of the clinical

of the test. In this case, it is a condition of inclusion of the subject in the

clinical trials implementation record of this fact in the medical

documentation of patient-led, which shall be signed by the investigator and a witness.



§ 19



The obligations of the contracting authority clinical trials



(1) the contracting authority is obliged to clinical trials



and the investigator's brochure) to determine the which must



1. have the relevant professional and specialized competence, experience

and knowledge on the use of the medical device to be tested,



2. to be authorised to carry out relevant professional activities and



3. know the clinical environment, in which the clinical examination carried out,



(b) ensure the preparation of the dossier) clinical trials and



(c) enter into a written contract in accordance with) § 14 paragraph. 2 (a). k).



(2) the contracting authority is obliged to further clinical trials



and after agreement) to ensure the investigator



1. the collection and evaluation of statistical data,



2. selection of subjects and the



3. methods and procedures to record and analyze all adverse

events and serious adverse events encountered while testing

medical device,



(b) ensure that the investigator's brochure)



1. the manual of the investigator, which means a document containing the file

technical, clinical and preclinical data on tested medical

the device, which are essential for the participants in clinical trials,

where appropriate, additional information necessary for the implementation of specific clinical

the tests,



2. where appropriate, guidelines, guides, mentoring focused on the intended purpose of the

medical device under test,



3. technical data on the health of the resource, including the results of the test

risk analysis,



4. information obtained from preclinical trials relating to the subject

clinical trials,



5. Declaration by the manufacturer or an authorised representative, the

medical device complies with the essential requirements laid down for the

medical devices conformity assessment pursuant to other legal

the rules governing the technical requirements on products, in addition to the aspects

which are the subject of clinical trials, and that with regard to these aspects

He has taken all precautionary measures to protect the health and safety of

the subjects, and the



6. information on whether the medical device contains the active substance,

derivatives of human blood or plasma, or whether it is made with the use of

rendered non-viable cells or tissues of human or animal origin or their

derivatives,



(c) approve and confirm by signature)



1. the plan for clinical trials and



2. the final report of the clinical test,



(d) insurance for the case of) damage, personal injury or death,

valid throughout the period of implementation of the clinical trials,



(e)) to pass to the zkoušejícímu medical device intended for clinical

the tests and the clinical trials referred to in the plan,



(f) notify the competent in writing in advance) the ethical Commission of the intention to implement

the clinical examination,



(g)) before the start of clinical trials, in the case of a medical device,

which is not provided with the CE marking or to be in the context of the clinical

the tests used for other than the original intended purpose, submit the Institute

request for authorisation to perform clinical tests; for amendments to the conditions

in the course of clinical trials is an obligation to submit an application to the Institute of

to enable these changes, likewise,



h) in the case of acceptance, to examine and approve any deviation and change

in clinical trials, and submit the plan to the Ethics Committee proposal for changes in the

clinical trials for its documentation of the reconciliation



I) forthwith inform the Department and the Ethics Committee of the initiation

clinical trials,



(j)) in the course of clinical trials provide the Institute and the relevant ethical

Commission annual report on the progress and evaluation of the safety of clinical trials,

and no later than 31 December 2006. January of the following year,



k) within 30 days, inform the ethics Institute and the Commission of the

suspension or termination of clinical trials, including the reasoning in

the case of early termination,



l) after their clinical trials to present the Constitution and relevant ethical

the Commission report on the clinical examination,



m) keep records of all adverse events and serious

adverse events encountered while testing the medical

the device, which had been reported during the clinical trials, for

at least 5 years and in the case of implantable medical device

at least 15 years from the date of manufacture of the last product and



n) to assess, together with the investigator all serious adverse events

occurring during the testing of the medical device and inform the
other investigators, the Institute and the ethical Commission immediately after their creation;

Essentials reporting serious adverse events the Institute provides

the implementing legislation.



section 20



The duties of the investigator



(1) the examiner and, in the case of multicenter clinical trials also main

the investigator is obliged to



and only take such risks), which cannot seriously threaten the bodies

Guest,



(b)) to assess whether the health status of subjects allows you to start

clinical trials,



(c) ensure compliance with the conditions referred to in) section 18,



(d) to ensure accuracy, readability) and data protection for the clinical test,

the information in the documents and the records of the trial subjects remains and



e) notify without undue delay, all adverse events and serious

adverse events occurring during the testing of the medical device

the sponsor clinical trials.



(2) the investigator and, in the case of multicenter clinical trials also main

the investigator is obliged



and) before the start of clinical trials



1. request from the contracting authority's clinical trials all the information that

considers it absolutely necessary to perform clinical trials,



2. meet in the appropriate range, with the intended purpose of the test

the medical device and the manufacturer's instructions,



3. properly acquainted with the plan of clinical trials, including its amendments, the plan

clinical trials requires that you confirm by signature,



4. writing honestly declare that he and his collaborators are able to

perform the clinical exam and that he and his colleagues do not have to

the subject of clinical trials no personal relationship, which could cause

conflict of interest or undermine the progress of the clinical trials, in particular with regard to the

the concurrent implementation of other clinical trials that are personally involved,



5. ensure that the necessary measures in the event of the occurrence of the adverse event

incurred in testing the medical device under performed

clinical trials,



6. secure the health assessment of trial subjects,



7. proven to meet subjects with their health,



(b)) in the course of clinical trials



1. the participation of the subjects vidovat to the clinical test,



2. to inform about the participation of the subjects in the clinical test of its

registering a provider in the field of general practical medicine or

in the field of practical medicine for children and adolescents,



3. immediately notify the contracting authority of all clinical trials

adverse events and serious adverse events resulting from

testing of medical device and of the measures taken,



4. discuss with the sponsor clinical trials necessary schedule changes

clinical trials; without his written consent, these changes

to implement; This procedure shall not apply in the event of a critical situation

pointing to a threat to the health of the subjects; such deviations from the

plan clinical trials do not require the prior approval of the Ethics Committee or

sponsor clinical trials, but must be notified without delay

the sponsor clinical trials, and



5. check whether the persons involved in the implementation of the clinical

tests, performs the tasks properly, which transferred to them,



(c)) after their clinical trials requires and to confirm by signature

the final report of the clinical test.



section 21



Documentation of clinical trials



(1) documentation of clinical trials forms



and) before the start of clinical trials



1. the written agreement between the contracting authority and provider of clinical trials

health services, for which the clinical examination carried out,



2. the written agreement between the sponsor and the investigator, clinical trials in

the case of multicenter clinical trials also between the sponsor of clinical

the tests and the principal investigator, defining their responsibilities and

confidentiality,



3. the investigator's Guide,



4. the plan for clinical trials,



5. the written consent of the Ethics Commission,



6. to enable the Institute to carry out clinical trials, it was granted,



7. informed consent under section 18,



8. proof of insurance the whole course of clinical trials for

in case of damage, injury or death,



9. a statement of whether a medical device contains as its

an integral part of the healing substance or a human blood derivative or

plasma,



10. a statement that the medical device in terms of minimizing

the risk of transmission of TSEs to humans diseases made using animal tissues

origin, and



11. a statement that the medical device meets the basic

requirements for medical devices in the conformity assessment

under other legislation governing technical requirements for

the products, with the exception of aspects, which are the subject of clinical trials,

and that, with regard to these aspects have been taken precautionary measures to

protect the health and safety of the user and the patient,



(b)) in the course of clinical trials records of



1. activities carried out according to plan clinical trials,



2. in advance of unforeseen occurrences and measures taken above and beyond

plan for clinical trials and



3. all adverse events and serious adverse events

incurred in testing the medical device, if their

the creation,



(c)) the report on clinical test.



(2) the provider of health services maintains documentation of clinical

the test for at least 15 years after its termination.



Section 3



The final report of the clinical trial



section 22



(1) the final report of the clinical trial includes in particular



and the name of the investigational medical device), and its more

the specification, including the definition of the intended purpose,



(b) the manufacturer's identification data) of the investigational medical device, and

the evaluator, which shall indicate the skills and practice



(c) information on the assessment of effectiveness) of the investigational medical device

declared by the manufacturer in terms of the intended purpose,



(d)) clearly defined mechanism of action and peace action

an investigational medical device on the patient,



e) safety assessment of investigational medical device with

regard to the patient,



f) evaluation and preclinical chemical and physical analyses, if they have been

carried out,



g) summary and conclusion, that contains unique opinion of the evaluator,

whether for an investigational medical device proven

the safety and effectiveness, and



h) date and place of the copies of the final report of the clinical trial,

the signature of the evaluator and signature of the manufacturer.



(2) in the event that the clinical data were obtained according to the procedure under section 11 (2).

3 (b). (b)), or (c)), is part of the final report of the clinical trial

further



and the proof of equivalence) an investigational medical device with another

medical device, on which the evaluator referred and follow up

his clinical data obtained on the basis of the



1. one or more clinical trials or other studies reported in the

the literature, or



2. published or unpublished professional reports or conclusions about

its use in clinical practice, and



(b)) a summary of the literature used.



(3) in the event that the clinical data were obtained according to the procedure under section 11 (2).

3 (b). and), is part of the final report of a clinical trial on



and clinical trials, name)



(b) the implementation of the goals and rationale) clinical trials,



(c)) date of commencement and completion of clinical trials,



(d) the identification and justification of selection) of the subjects,



(e) a list of the performances provided by the health) of the subjects,



(f) a description of the methods of measurement and) justification for the appropriateness of their use,



g) used statistical methods,



h) detailed description of the adverse events and serious adverse

events encountered while testing the medical device,



(I) a copy of the approval of the Ethics Committee) and



j) copy of the authorization of the Institute to perform clinical trials, it was granted.



Part 3



Performance evaluation



section 23



The implementation of performance evaluation



(1) the evaluation of the performance of process, which results in

It is a critical evaluation of the data obtained by the use of the diagnostic

in vitro medical device in accordance with the intended purpose and

Verify that achieves the performance specified by the manufacturer, taking account

the sensitivity to the analysis, the sensitivity for diagnosis, analysis

diagnostic specificity, pertinence, accuracy, repeatability,

reproducibility, minimizing interference and the determination of the limits of

detection.



(2) the contracting authority of the performance evaluation shall mean a person who

eating for health service providers carry out the evaluation

the performances and which ensures the initiation, management, organization,

control, where appropriate, the financing of the performance evaluation.

The performance evaluation, the contracting authority must be established on the territory of the

the Member State must grant a power of attorney or a person who is seated on the

territory of a Member State.



(3) performance evaluation of diagnostic medical

resource in vitro is performed according to § 11 (1). 1 and 2, mutatis mutandis, with

given the absence of direct exposure to the investigational diagnostic

in vitro medical device on the diagnosed person.



(4) the provisions of § 11 (1). 3 and 4 for performance evaluation

shall apply mutatis mutandis.



section 24



Notification of performance evaluation
Performance evaluation of diagnostic medical device

in vitro, which is not provided with the CE marking, or that is in the context of the

performance evaluation is used for other than the original intended

the purpose may be carried out by the health services provider established in

the territory of the Czech Republic only on the basis of the report of the Institute. The announcement of

the contracting authority conducts performance evaluations or the person that

granted the power of attorney under section 23(1). 2 electronically via the

Registry of medical devices, and not later than 15 days before the

the start of the performance evaluation. Essentials report provides

the implementing legislation.



§ 25



The final report from the performance evaluation



The final report from the performance evaluation contains in particular



and the name of the investigational diagnostic) medical device for in vitro

his further specification and definition of the intended purpose,



(b) a list of the most common diseases), which can be through

in vitro diagnostic medical device to prove or

exclude,



(c) the manufacturer's identification data) of the investigational diagnostic

in vitro medical device and the evaluator,



d list of reference materials),



e) list and description of the methods of measurement,



(f) the number of samples tested)



(g) a list of the clinical laboratories), if the evaluation of the functional

eligibility is carried out outside the premises of the manufacturer,



(h) a list of the parameters obtained) specificity, sensitivity, accuracy and

reproducibility,



even) number of stakeholders performance evaluation in case of

medical device for self-testing,



j) summary and conclusion, that contains unique opinion of the evaluator,

whether for investigational diagnostic medical device in

vitro demonstrated his functional capacity and



to date and place copies of) the final report of the evaluation of the functional

eligibility, the signature of the evaluator and signature of the manufacturer.



TITLE IV



REGISTRATION AND NOTIFICATION



Part 1



Registration of persons handling of medical devices



section 26



Reporting obligation



(1) a person established on the territory of the Czech Republic, which intends, under its

own name, business name or the name of the placing on the market of the medical

resources, the Institute must report their activities to the manufacturer, prior to

you start placing medical devices on the market.



(2) a person established on the territory of the Czech Republic, which intends to represent the

producers established outside the territory of the Member States, must Institute report their

the activities of authorised representative before the commencement of such activity.



(3) a person who, in the territory of the Czech Republic intends to act as the importer,

the Distributor or the person performing the service, must Institute report their

the activity of the importer, the Distributor and the person conducting the service, before the

commencement of such activity. This obligation shall not apply to importers and the

distributor of medical device risk class I and

in vitro diagnostic medical device, which does not belong to the

list A or B, nor is it a medical device for self-testing.



(4) a person established on the territory of the Czech Republic, which acts as a

notified person shall Institute report their activities notified

persons, and at the latest within a period of 6 months from the date of commencement of activities.



(5) the sponsor clinical trials carried out by the health provider

services established in the territory of the Czech Republic shall Institute report their

activity, before starting clinical trials.



(6) to the submission of the report of the person through the registry of medical

You can authorise another person. Power of attorney can be the principal grant and

the agent take also in electronic form through the registry

medical devices.



section 27 of the



Contact person



(1) the person handling medical devices referred to in section 26

designate a contact person.



(2) the contact person must have professional preconditions for ensuring

communication between a person and the handling of medical devices

State administration bodies.



section 28



Essentials reporting



(1) the Declaration of a person is served electronically via the registry

medical devices.



(2) the Declaration shall in addition to the requirements laid down in the administrative regulations of the

contain



and the name and phone) e-mail address of the contact person



(b) the designation of the activity) is to produce,



(c)) with the manufacturer individually made medical devices to determine the

generic groups produced by medical devices,



(d)) at the authorised representative of the manufacturer containing the data zastupovaném

the name, business name or the name of the person and the address of its registered office,



(e) persons performing service) for a list of manufacturers whose medical

the means of implementing the service, containing the business name or the name of the person and

the address of its registered office, a copy of the document on training the professional maintenance pursuant to section 65

paragraph. 4 (b). (b)) or section 66 paragraph. 2 (a). (b)) from each manufacturer or

authorized persons and a copy of the authorization of such person by the manufacturer, and



(f)) for more information to be passed to the Czech Republic to the Eudamed on the basis

Commission decision published in the official journal of the European Union.



section 29



The procedure of registration of the person



(1) the Registration of the person is acquired by issuing a confirmation of compliance with the reporting

obligations. The Institute performs the registration of a person in the register of medical

resources without undue delay after the fulfilment of reporting obligations. In

If that is not met any of the requirements referred to in section 28, the Department of

shall invite the applicant to supplement the report.



(2) Department of each registered manufacturers, authorised representatives,

the importer, the Distributor, the person conducting the service, the contracting authority clinical

tests and notified the person in writing to the registry of medical

resources shall be assigned a registration number. If one person made

multiple registration activities under this Act, that person is assigned

only one registration number.



(3) in the case of changes to the data referred to in the marketing authorisation, the manufacturer,

authorised representative, the importer, the distributor, the person performing the service,

the sponsor clinical trials or notified shall, within 30 days

The Institute report a change in these data electronically via the registry

medical devices. Notification of changes to the data must contain

the registration number assigned by the Institute and update data

have changed. The Institute performs the change registration without undue delay.



(4) If the Department finds a duplicate record of the person, shall decide ex officio

to exclude the person from the register of the duplicate record of medical

resources. The decision to delete is the first act in the proceedings and does not have

suspensory effect.



(5) at the request of the manufacturer, the authorised representative, the importer, the Distributor,

the person conducting the service, sponsor clinical trials or notified

a person performs the erasure from the register of persons, the Institute of medical devices.



section 30



Validity and renewal of registration of the person



(1) the person's Registration is valid for a period of 5 years from the date of issue of the certificate of

the fulfilment of reporting obligations.



(2) the registration of a person can be repeatedly extended, and it's always on for 5

years. A person who intends to continue the activities reported this

the fact the Institute first 6 months before the date of its expiry,

but no later than 2 months before the deadline expires; for essentials

the announcement applies to section 28 apply mutatis mutandis. The Institute performs the registration without renewal

undue delay.



(3) the period of registration renewal builds on the last day of the originally

set the validity of the registration.



Part 2



Notification of the medical device



section 31



Medical device notification placed on the market by the manufacturer or

authorised representative



(1) if the manufacturer or his authorized representative established in the territory of the Czech

the Republic is obliged to submit a request for notification of the Medical Institute

resource lists on the market, and not later than 15 days from the date of its

placing on the market. This obligation applies to the authorised representative

established on the territory of the Czech Republic and in the case where the medical

device is placed on the market by another person. This obligation shall not apply to

individually made medical device.



(2) for the submission of the notification of the medical device can be empowered

another person. The full power of the principal, the agent can grant and accept

also in electronic form through the registry of medical

resources; the authorisation may be granted only to a person of this empowered to submit

Declaration in accordance with § 26 paragraph. 6.



§ 32



The elements of the request for notification of the medical device placed on the

the market by the manufacturer or authorised representative



(1) a request for notification of the medical device under section 31 shall be made

electronically through the registry of medical devices.



(2) the request must in addition to the requirements laid down in the administrative regulations contain



and the registration number of the manufacturer) or the authorized representative of the allocated

The Institute,



(b)) the trade name of the medical device,



(c) the name of the add-in) that indicates each version of the medical device,

If there are,



d) catalogue number allocated to each medical device variants

by the manufacturer, if this number is there,



e) intended purpose in the Czech and English language,



(f)) code and name, the generic medical device group
g) information that the in vitro diagnostic medical device belongs to

to the list and list B or a or is a medical device for the

self-testing or belong to other diagnostic medical

in vitro means, or that it is the active

implantable medical device, in other cases, the risk

class



h) information as to whether the clinical test was carried out,



I) date of entry of the medical device on the market,



j) in the case of the medical device with which it is compulsory the participation of notified

the person on the conformity assessment process, the number of the certificate issued by the

by a person, the number of notified the person who issued the

certificate, and a copy of a valid certificate,



for a copy of the final report) from a clinical trial, or from guest

the performances,



l) the current version of the instructions for use in the Czech language; This condition

need not be met in the case of the medical device risk class I or

IIA, if the manufacturer has provided it for the safe use of

the medical device is not necessary,



m) a valid certificate of conformity and



n) for more details to be passed to the Czech Republic to the Eudamed on the basis

Commission decision published in the official journal of the European Union.



section 33



Medical device notification supplied by the Distributor or

the importer



(1) the Distributor or the importer of a medical device shall be required to submit

The Institute a request for its notification, not later than 15 days from the date of its

placing on the market or supply on the market in the Czech Republic. This obligation shall

not apply to individually prepared medical device on

medical device risk class I and the diagnostic medical

in vitro means, which do not belong to the list and not list B and even

It is not a medical device for self-testing.



(2) If a medical device has already been notified, is each other

Distributor or the importer of a medical device shall

The Institute reported that the medical device also distributes or

imported. This report performs a distributor or importer electronically

through the registry of medical devices.



(3) to request a notification device can empower

another person. The full power of the principal, the agent can grant and accept

also in electronic form through the registry of medical

resources; the authorisation may be granted only to a person of this empowered to submit

Declaration in accordance with § 26 paragraph. 6.



§ 34



The elements of the request for notification of the medical device supplied

a distributor or importer



(1) a request for notification of the medical device supplied

a distributor or importer shall be submitted electronically through

Registry of medical devices.



(2) the request must in addition to the requirements laid down in the administrative regulations contain



and) the registration number assigned to the Distributor or importer by the Institute,



(b) the name, business name) or the name of the manufacturer and the address of its registered office,



(c)) for a manufacturer established outside the territory of the Member States the name, business name

or the name of the authorized representative and the address of its registered office,



(d)) the trade name of the medical device,



(e) the name of the add-in) that indicates each version of the medical device,

If there are,



f) catalogue number allocated to each medical device variants

by the manufacturer, if this number is there,



g) intended purpose in the Czech language,



h) information that the in vitro diagnostic medical device belongs to

to the list and list B or a or is a medical device for the

self-testing or belong to other diagnostic medical

in vitro means, or that it is the active

implantable medical device, in other cases, the risk

class



even) for the medical device, which is a mandatory participation of notified

the person on the conformity assessment process, the number of the certificate issued by the

by person and number of the person who issued the notified

certificate, and



(j)), the current version of the instructions for use in the Czech language; This condition

need not be met in the case of the medical device risk class I or

IIA if the manufacturer stated that it is not necessary for the safe

the use of the medical device.



section 35



The procedure for notification of the medical device



(1) Notification of the medical device to the acquisition of legal power arises

the decision on the notification. Against the decision, which the applicant complies with the Institute

in its entirety, cannot be appealed. The Institute performs the registration of medical

Resource Registry of medical devices without undue

the postponement.



(2) if the Department determines that the product is not a medical

means to him or the CE marking has been affixed unduly, the request

will be rejected. In this case, it is considered that the applicant has not complied with the obligation to

under section 31 or 33.



(3) Department of each notified the medical device registration

to the registry of medical devices shall assign a registration number and one

for each variant of the identification code.



(4) in the case of changes to the information provided in the notification to the manufacturer,

authorized representative, distributor or importer shall, within 30 days

The Institute a request for change notifications electronically via the registry

medical devices. The application must include the registration number

the applicant, the registration number of the medical device and the identification code of the

each of its variants, and update the data that have changed.



(5) If new facts come to light, from which it follows that

the product notified as a medical device is not medical

the means, or the CE marking has been affixed unduly, the Institute

shall decide ex officio of its deletion from the registry of medical

resources. If the Department finds a duplicate of the notification of the medical

resource, ex officio, shall decide on the deletion of the duplicate record;

the decision about this deletion is the first act in the proceedings and does not have suspensory

effect.



(6) on the request of the manufacturer, the authorised representative, distributor or

the importer, the Department shall include in the registry of medical devices information that

medical device is no longer sold or supplied by these persons on the

the market.



section 36



Force and extension of the notification of the medical device



(1) Notification of the medical device is valid for a period of 5 years from the date of

the entry into force of the decision on the notification.



(2) the notification can be repeatedly extended, and it's always for a period of 5 years.

Request for extension of the notification may be made 6 months before the date of

its expiry, but no later than 2 months before

the end of; requirements for application for extension of the notification according to § 31

section 32 shall apply, mutatis mutandis, and the requirements for an application for the extension of the notification

According to § 33 section 34 shall apply mutatis mutandis. The Department shall issue a decision on the extension of the

notification without undue delay.



(3) the period of extension of the notification follows on the last day of the originally

set the validity of the notification.



Part 3



Certificate of free sale



§ 37



(1) a certificate of free sale is a public deed certifying that the

medical device has met the conditions for the placing on the market. Certificate

free sale is issued to manufacturers of notified medical

the resource located within the territory of the Czech Republic, at his request, in order to

export of medical device outside the Member States.



(2) the request shall be filed electronically through the registry

medical devices and must in addition to the requirements laid down by the administrative

the regulations contain



and the registration number of the manufacturer)



(b)) the registration number of the medical device and the identification code of the

variants and



(c)) whether the certificate is required, the free sales

electronic or paper form.



section 38



(1) the Institute shall verify in Registry of medical devices that the competent

medical device is notified and that the date of implementation of the

There was no change notification, which prevent the issue of a certificate

free sales.



(2) the Institute shall issue a certificate to the applicant without undue delay of the free

sales or shall reject the application.



(3) a certificate of free sale is valid for a period of 5 years from the date of its

the release, however, after the longest period of validity of the medical notification

resource on it. To request a new certificate may be issued

free sales, even if that is a previous certificate of free sale

still valid.



THE HEAD OF THE



THE UNAUTHORIZED CONNECTION OF THE CE MARKING AND CLASSIFICATION



section 39



The unauthorized connection of the CE marking



(1) If a product which has been marketed as a medical

the resource is the CE marking has been affixed unduly or this sign

is missing in violation of the law governing the technical requirements on products,

The Institute will invite the manufacturer or the authorised representative of the alternative

axle. If it is not the manufacturer or the authorised representative of the corrective action

not later than 60 days from the date of receipt of the request referred to in the first sentence, it shall issue

Department of the decision on the withdrawal of the product from the market. In the case where the product is

eligible to endanger the health of users, the Institute shall issue a decision on the withdrawal from the

the market and out of circulation without a prior call to remedy; about this procedure

shall immediately inform the manufacturer or the authorised representative.



(2) the documents in the proceedings referred to in paragraph 1 shall be notified to the public

by Decree, and it means that allow remote access. The document is
considered to have been delivered on the fifth day after the fly.



(3) the Institute shall issue a decision on the withdrawal from the market or from circulation in accordance with

paragraph 1, it shall inform the Commission and the competent authorities of the

of the Member States.



section 40



The decision on the classification of medical device



(1) if it is on the market in the Czech Republic listed medical device, u

where there are doubts that he was correctly classified by the manufacturer according to the measure

health risk according to § 6 (1). 1, the Department shall issue a decision on the

the classification.



(2) the proceedings referred to in paragraph 1 shall start the Institute on the basis of the application or of the power

official.



(3) if it is not possible on the basis of the evidence available to issue a decision on the

the classification referred to in paragraph 1, or if it is a type of medical

a resource that is in the Member States of the non-classified, Institute of

shall submit a request to the Commission to issue a decision on the correct classification of

the medical device and the issue of measures for the entire market of the Member

States.



§ 41



The decision on the border of the product



(1) the Institute shall issue a decision declaring that the product is or is not

medical device, in the event that the



and such a product meets the definition of) the medical device, although

the manufacturer is not properly placed on the market as a medical device, or



(b) such a product does not fulfil the definition of) the medical device,

Although it is put on the market by the manufacturer as a medical device.



(2) the proceedings referred to in paragraph 1 shall start the Institute on the basis of the application or of the power

official.



(3) is not-limožné on the basis of the evidence available to issue a decision, or

If the product, which in some Member States is intended as a

medical device and the other not, submits an application for

the decision to release the correct destination of the product and the issue of measures for the entire

the market of the Member States.



TITLE VI OF THE



DISTRIBUTION AND IMPORTATION



Part 1



Distribution



section 42



(1) the distribution of the distributor may only be registered by the Institute.



(2) a Distributor may deliver only further medical device

the Distributor, the providers of health services, výdejci, or

to the seller.



§ 43



A medical device shall not be distributed, if it can be

reduced or affected by the efficiency of the safety of the medical device in

as a result, that



and) violation of the storage conditions specified by the manufacturer,



(b)), its application has elapsed



(c)) has been infringed its original packaging, or are missing or not

read the label on the packaging, or



(d)) was a deterioration of its technical condition.



Part 2



Imports



§ 44



(1) Importation, the importer must be registered by the Institute.



(2) the importer of a medical device can deliver only the Distributor,

the providers of health services, výdejci, or the seller.



Part 3



Provisions common to the distribution and importation



section 45



(1) Distributed and imported may be the only medical device for

the Declaration of conformity has been issued and which was marked

The CE marking. The condition referred to in the first sentence shall not apply to the distribution of individually

a view of the medical device.



(2) the Distributor and importer are obliged to act in accordance with good

import and distribution practices, which means a set of rules

laying down the requirements for the maintenance of safety and performance

medical device, in particular



and to provide storage and management), the medical device in

accordance with the instructions for use and the instructions of the manufacturer; for health care

funds risk class IIb, III and active implantable

medical devices must be the distributor and importer of trained

by the manufacturer, authorised representative or by a person authorized in writing by them;

the person who conducted the training, distributor or importer shall issue

the Distributor or the importer document about this training; the obligation to

training does not apply to persons who treat medical

devices in class IIb and III, whose use and disposal is

widely known; provides a list of such medical devices

the implementing legislation,



(b)), to observe the rules of good distribution practice of defining and import

a range of obligations to maintain the original characteristics

medical device within the distribution and importation,



(c)) to perform a regular check of the medical device and, where appropriate,

it out of other distributions with respect to possible risk reduction

safety or affecting the effectiveness of the medical device,



(d) to transmit its) suppliers and customers all the important information

eligible affect the safety and health of users of a distributed

medical device, with which they were familiar, and



e) keep all documents relating to the distributed or

imported medical resource for 5 years;



more detailed rules of good distribution practice and lays down detailed import

legal prescription.



TITLE VII



THE PRESCRIBING, DISPENSING AND SALE



Part 1



The prescription



section 46



Medical prescription



(1) a medical device may prescribe only a doctor or dentist

(hereinafter referred to as "the doctor"), and the issuing of prescription, which is

the voucher.



(2) a medical device that (i) in the case of compliance with the intended purpose of the

may endanger the health or life of man, if not used under

supervision of a physician, may be issued only on the voucher. List of groups

such medical devices laid down detailed legal prescription.



(3) the medical device is issued on the voucher also in the case where the

the patient shall be entitled to remuneration according to the law governing the public

health insurance.



section 47



Issuing the certificate



(1) the voucher can be issued only in paper form.



(2) on the gift voucher cannot be placed the characters or elements that limit the readability

fill in the data, the data on other health services providers

or any advertising message.



(3) if the prescribing physician will prescribe medical device

that according to the law governing public health insurance is not paid

from public health insurance or paid partially, the

obliged to notify this fact to the patient.



(4) When a request for a recurring prescription medical device

assess the prescribing doctor, if that is possible, the status of the used

the medical device. If the medical device conforms to the

therapeutic, functional and security, new medical

means of identical type if not prescribed.



section 48



Treatment with pointing and the time of its application



(1) the Blank form for the voucher shall not be stamped

provider of health services.



(2) the voucher with the prescribed medical device can be applied to 90

days from the date of its issuance, unless the prescribing physician with regard

on the State of health of a patient or the nature of the medical device

otherwise.



(3) the particulars of the voucher lays down detailed legal prescription.



Part 2



Issue



section 49



Conditions of issue



(1) may be Issued only by a medical device, which has been

the Declaration of conformity is issued and that the CE marking has been affixed to it; This

the condition does not apply in the case of individually prepared medical

resource.



(2) a medical device can be issued only at the pharmacy, picks and shovels

medical devices, opticians or contract the picking list.



(3) medical device may at the pharmacy or medical picks and shovels

the funds issue only



and specialised competences) pharmacist,



b) pharmacist with competence,



(c)) the pharmaceutical Assistant with specialised competences for professional

Department for the dispensing of medical devices,



d) pharmaceutical Assistant with professional competence, or



Orthotics-Prosthetics) qualified to practise the profession without mentorship

If this is an issue of prosthetic orthotic-medical

resource.



(4) an optical device may be issued only in eye optics.

Such a medical device can issue only



and optometrista,)



b) Chartered optician or degree in optical techniques, or



(c)), optician or eye techniques.



section 50



Mail order picking



(1) the Shipping issue, means the issue of medical device

shipping way compared to the card.



(2) mail order picking can provide only the picking list.



(3) in the case of the medical device referred to in section 46 paragraph. 2 is the mail order

issue disabled.



section 51



Obligations of persons providing mail order picking



When a mail order medical device issue is the picking list shall

to ensure the



and the publication of information on the packing) issue, health-care menu

resources, their price and the costs associated with shipping issue on

their website,



(b)) the packaging and transport of consignments of medical devices to the

delivery to the customer in a way that will ensure the conservation of their quality;

the person providing mail order picking is responsible for the maintenance of the quality

medical devices, and even in the event that the contract shall ensure that

transport of medical resources for the other person,



(c)) that the consignments were sent to the customer within 2 working

days from the date of receipt of the order, or that the client is informed of the

longer delivery time limit before you binding a medical device

orders,
(d) information service provided by the person) under section 49, paragraph. 3 and 4 after the

stage operating hours; This information service is also to

ensure the collection and transmission of information on the occurrence of the adverse

events,



(e) return reklamovaných) the possibility of medical devices in a manner

that does not cause the customer costs; such medical resources

become unusable, and is necessary to ensure their removal.



section 52



Swap



(1) issue of the medical device prescribed for the voucher

issuing inform the patient about possible alternatives to the prescribed

medical resource and with his consent is entitled to change it

other medical device that is interchangeable with the prescribed

medical device with regard to the effectiveness and the intended purpose.

Performed by issuing the voucher shall indicate the substitution.



(2) if the prescribing physician or doctor with health insurance review

regard to the health status of the patient insists on the release of the prescribed

medical device, indicate on the voucher, the words "not to be confused". In

this case may issue only issuing prescribed medical

resource.



section 53



A statement from the card



If the issuing available the prescribed quantity or type of

medical device, medical device missing

listing of the card marked "Listing". Listing of the card contains information

the original voucher and an indication of the extent of past issues. On the original

the voucher shall be marked "Taken a dump" and an indication of the extent of the

past issues. For the determination of the period of application of the extract of the certificate

shall apply section 48, paragraph. 2 by analogy.



§ 54



The obligations of the picking list



The picking list is obliged to



and to provide storage and management), the medical device in

accordance with the instructions for use and the instructions of the manufacturer,



(b)) to perform a regular check of the medical device and, where appropriate,

delete it with regard to the possible risk of safety or

affecting the effectiveness of the medical device,



(c) to transmit all the information for the patient) of the facts of the eligible

affect its safety and health in connection with the use by the

medical device,



(d)) to keep all documents relating to the issued medical

the resource, including the medical regulations, for a period of 5 years, and



(e) to abide by other rules), pursuant to section 45, paragraph. 2 adequately.



section 55



The prohibition on supply



(1) a medical device shall not be issued if was reduced

the safety or effectiveness of a medical device is affected as a result of

the fact that the



and) violation of the storage conditions specified by the manufacturer,



(b)), its application has elapsed



(c)) has been infringed its original packaging, or are missing or not

read the label on the packaging, or



(d)) was a deterioration of its technical condition.



(2) medical devices, which have been phased out of the issue must be

stored separately from medical devices, which can be issued; with

These medical devices shall be treated in accordance with other legal

the rules relating to the management of waste.



Part 3



Sale



section 56



Conditions of sale



(1) may be the only medical device for which it was

the Declaration of conformity is issued and that the CE marking has been affixed to it; This

the condition does not apply in the case of individually prepared medical

resource.



(2) the seller is obliged to



and to provide storage and management), the medical device in

accordance with the instructions for use and the instructions of the manufacturer; for health care

funds risk class IIb, III and active implantable

medical devices must be trained by the manufacturer, authorised

the representative, in writing, by the person authorized by the Distributor or the importer;

the person who conducted the training of the seller, shall issue him a proof of this

training; training obligation does not apply to persons who

treat medical devices in class IIb and III, whose use

and dealing with them is generally known; the list of such medical

resources on detailed legal prescription,



(b)) to perform a regular check of the medical device and, where appropriate,

delete it with regard to the possible risk of safety or

affecting the effectiveness of the medical device,



(c) to transmit to your supplier and) the user all important information

eligible affect the health and safety of the user, sold

medical device, with which he was familiar,



(d)) to keep all documents related to the sale the medical

resource for 5 years and



(e) to abide by other rules), pursuant to section 45, paragraph. 2 adequately.



§ 57



(1) a medical device shall not be sold if it has been reduced

the safety or effectiveness of a medical device is affected as a result of

the fact that the



and) violation of the storage conditions specified by the manufacturer,



(b)), its application has elapsed



(c)) has been infringed its original packaging, or are missing or not

read the label on the packaging, or



(d)) was a deterioration of its technical condition.



(2) medical devices, which were excluded from the sale, must be

stored separately from medical devices, which can be sold; with

These medical devices shall be treated in accordance with other legal

the rules relating to the management of waste.



TITLE VIII



The USE of the



section 58



General provisions



In the provision of health services may be used only by the medical

the resource for which a declaration of conformity has been issued and that was

CE marked; This condition does not apply if the individual

prepared a medical device or medical device, u

which it lays down the law.



section 59



The obligations of the provider of health services in the application of

medical device



(1) the provider of health services is required to ensure that



and) was a medical device used only for the intended purpose in accordance with

the manufacturer's instructions,



(b)) medical device with measuring function was operated in accordance with the

the requirements of other legislation relating to the area of metrology,



(c)) medical device used in the provision of health services

only a person who on the basis of appropriate education and practical

the experience provides sufficient assurance expert use of this

medical device in accordance with the instructions for use,



(d)), the person providing health services through the health

the device and the patient were advised of the need to make sure before

the use of the medical device for its proper technical condition,

functionality and options for safe use, if such verification

medical device comes into account; This requirement is

apply mutatis mutandis to Accessories, software and more

the product, which implies interaction with the medical

means,



(e)), when the medical device has been compliance with the rules

According to section 45, paragraph. 2 reasonably and



(f)) was in the service of the medical device is carried out in accordance with this

by the law.



(2) the provider of health services may not use medical

resource in the provision of health services, if



and there is reason to suspect) that the health and safety of patients, or

third persons are at risk, even in the case that the medical

the resource is properly installed, or introduced into the human body,

maintained and used in accordance with the intended purpose,



(b)), its application has elapsed



(c)) has in terms of its production deficiencies that can lead to threats

the health of patients or third parties,



(d)) may be compromised or affected by the efficiency of the health

the resource due to the obviously corrupted the integrity of the original packaging,

or



e) has instructions for use available in the Czech language; This condition

need not be met in the case of the medical device risk class I or

IIA, for which the manufacturer has established that it is not necessary for the safe use of

the medical device.



(3) if it is in the provision of health services use the active

implantable medical device or medical device

risk class IIb or III, shall be made in the record of this

medical documentation kept by the patient.



(4) Health Services Provider is obliged to maintain documentation

used medical devices,



and for which) must be carried out,



(b)) which must be carried out according to the manufacturer's instructions and maintenance



(c)) that the law governing the area of metrology marked

as a working meter.



Requirements documentation used medical devices provides

the implementing legislation.



section 60



Information for users



(1) the provider of health services is required to ensure that the

available to the user the instructions for use of the medical device in the Czech

language and information relating to its safe use;

the obligation to ensure the availability of the operating instructions shall not apply for

medical device risk class I or Ii, for which the manufacturer

provided that it is not necessary for the safe use of the medical

resource.
(2) the physician responsible for the introduction of the implantable medical

the resource is bound to the patient, which was a medical device

introduced, where appropriate, its legal representatives or opatrovníkovi

provide detailed information to enable the identification

the medical device, including its accessories, together with the instructions

concerning the safety of the patient and his behavior, including, when

physician and patient which influences environment should not

exhibit at all or only in compliance with the appropriate preventive

the measures. On the lessons of the patient must be a written record

signed by both parties. In the event that a patient refuses

entry sign, this fact must be indicated in the record and the record

signed by the responsible doctor, and one witness.



(3) when informing patients in connection with the use of the medical

the resource is to be taken of the relevant instructions in the instructions for use and

the further information referred to in paragraph 1.



section 61



Briefing



(1) the active implantable medical device, active medical

resource risk class IIb or III, and medical device, u

which it has established, the manufacturer may only be operated by a person who



and graduated to the briefing) medical device or

a medical device which is identical to the type of work carried out in

accordance with the relevant instructions for use and



(b)) was made aware of the risks associated with the use of that

the medical device.



(2) Education can be carried out only by the person who on the basis of

the corresponding education, practical experience and lessons learned by the manufacturer

provides sufficient assurance expert instruction on the correct implementation of the

the use of the medical device.



(3) the provider of health services is required to keep and maintain

information about all your instruktážích. The following information is required to

keep for a period of 1 year from the date of the disposal of the medical device from the

the use of the.



Special use



section 62



(1) in the case of a threat to the life or health of the patient, the doctor may

providing health services to use the medical device in a manner

that is not in accordance with his instructions, if available

other medical device required properties, however, if such

How to use clinically validated for a similar type of medical

resource.



(2) if the doctor intends to use the medical device in

paragraph 1, it shall inform about this fact, and of the possible consequences and

the risks of this procedure, the patient or his legal representative

or guardian, and performs about record in medical documentation

led by the patient. If the State of health of a patient or

the absence of a legal representative or guardian introduction according to the sentence

First, the doctor immediately, as soon as the State of health of a patient

or the presence of his legal representative or guardian.



(3) the procedure referred to in paragraph 1, the reasons that led to this procedure,

and the submission of the information referred to in paragraph 2, the doctor will record in

medical documentation kept by the patient.



section 63



(1) in case of publication of a war or emergency ^ 4) and in the case of

the provision of health services with the use of medical devices

soldiers posted outside the territory of the Czech Republic ^ 5) can the Department of Defense

derogate from this Act when security forces ^ 6)

Czech Republic medical devices.



(2) the Czech Republic is responsible for the loss suffered as a result of the use of

medical device referred to in paragraph 1.



TITLE IX OF THE



SERVICE AND REVISION



Part 1



Service



section 64



General provisions



(1) the Service shall mean the implementation of the professional maintenance and repair of medical

resource in accordance with the manufacturer's instructions, this law and other legal

legislation; repair and technical maintenance of individually manufactured

the medical device is not considered a service pursuant to this Act.



(2) service of a medical device may perform only the legal

or entrepreneurial natural person registered by the Institute as a person

performing the service.



(3) in the case of a medical device with a measuring function must be

the service exercised in accordance with any other law governing the area

Metrology.



section 65



Professional maintenance



(1) the professional maintenance means the realization of regular security

technical controls and other operations aimed at maintaining security

and the full functionality of the medical device.



(2) part of the training is to further the implementation of the maintenance of electric control

medical device, which is an electrical device.



(3) Technical maintenance is carried out at a medical device with regard to the

its classification into risk class, in the extent and frequency of the set

by the manufacturer. If the manufacturer does not provide support for the frequency of maintenance

a medical device that is connected to the power source

energy, maintenance shall be carried out at least every 2 years.



(4) the person performing the service is required to



and) ensure that the maintenance was performed exclusively by the medical

the staff of at least one year of professional practice and competence to

the profession of biomedical engineering, biotechnického, Assistant

Biomedical Engineering, clinical technique, a clinical engineer

|-prosthetics, or workers with at least three years ' professional experience in the

the area of the maintenance of professional healthcare resources, or staff person

conducting the service, with at least three months ' work experience with the person

conducting the service,



(b)) to ensure all workers carrying out technical maintenance of their

training by the manufacturer or by a person authorized by the manufacturer,



(c)) if the professional maintenance of the medical device, which is

electrical equipment, to ensure that, in addition to the requirements referred to in point (a))

This professional maintenance personnel at the same time



1. meet the requirements for workers for a separate activity by

another legal act governing competence in

electrical engineering, or



2. comply with the requirements on workers who, according to other legal

the rules relating to professional qualifications in electrical engineering with supervision

the persons referred to in paragraph 1, and



(d)) to ensure adequate material and technical equipment for the implementation of the

professional maintenance.



(5) the provider of health services is required to keep and maintain

records made by professional maintenance for a period of 1 year from the date of disposal

the medical device from the application.



(6) the requirements set out on the workers performing Professional maintenance

do not apply to professional maintenance carried out for medical device

risk class without measuring function or for medical device

risk class I, which is an electric device.



section 66



Fix



(1) the Correction means the set of operations which is a corrupt medical

the resource back to the original or working condition, with

does not change the technical parameters of or intended purpose.



(2) the person performing the service is required to



and) ensure that the repair has been carried out exclusively by the medical

the staff of at least one year of professional practice and competence to

the profession of biomedical engineering, biomedical engineering,

clinical technique, clinical engineer |-prosthetics, or

workers with at least three years ' professional experience in the field of corrections

the relevant medical device or medical device

a similar species, or staff person conducting the service, and with it the

at least three months ' work experience in the relevant medical

a resource or the health of the resource of a similar type,



(b)) to ensure all workers engaged in the repair of their training in

the correction area, the relevant medical device in range

specified by the manufacturer, by the manufacturer or by a person authorized by the manufacturer,



(c)) if the correction of the medical device, which is

electrical equipment, to ensure that, in addition to the requirements referred to in point (a))

the personnel performing this repair at the same time



1. meet the requirements for workers for a separate activity by

another legal act governing competence in

electrical engineering, or



2. comply with the requirements on workers who, according to other legal

the rules relating to professional qualifications in electrical engineering with supervision

the persons referred to in point 1,



(d)) if the correction of the medical device, part of which is

the pressure device, ensure that the correction of the pressure equipment has been

implemented by the workers, who meet the requirements for the competence of

for the repair of pressure equipment provided by another law,



e) If this is a correction of the medical device, part of which is

the gas device, ensure that the gas equipment repair was

implemented by the workers, who meet the requirements for the competence of

for the repair of gas devices provided by other law, and



(f)) to ensure adequate material and technical equipment for the implementation of the

corrections.



(3) after the correction, which could affect the design or

the functional elements of the medical device, the person performing the service
to ensure that a worker performing repair and safety tested

the functionality of the medical device and the issuing of this examination

the written protocol. Health services provider is obliged to this

Protocol for at least 1 year from the date of the disposal of the medical

the resource from the application.



(4) the requirements on staff to ensure the repair is not covered by the

for repairs carried out by the medical device risk class without

the measuring function or for medical device risk class I

There is an electric device.



Part 2



The revision of the



§ 67



General provisions



(1) a medical device that is connected to the power source

energy, and medical device, part of which is the pressure or

gas equipment, in addition to the service performed and review by other

the legislation. The revision means electric review, revision and pressure

gas review.



(2) Electrical revisions means a specialized control of

Visual inspection of the file, and electrical measurements in the medical

resource, which is firmly connected to the electrical source

energy.



(3) Pressure revisions means the specialized control of

the file Visual checks and measurements in the medical device, which

part of the pressure equipment.



(4) revision of the Gas means a specialized control of

the file Visual checks and measurements in the medical device, which

part of the gas equipment.



section 68



Conditions for the implementation of the revision of



(1) the Review shall be carried out for medical device in the range and frequency of

provided for in other legislation governing electrical, pressure

and gas review, or by the manufacturer.



(2) the person conducting the review is required to ensure that electrical revision

It was carried out solely by the workers, who meet the requirements for professional

eligibility for the implementation of the revision of the electrical equipment set by another

the law governing the competence in electrical engineering.



(3) a person conducting a review of the medical device, which

the pressure equipment is required to ensure that the revision of the pressure equipment,

was carried out by workers who meet the requirements for professional

eligibility for the implementation of the revision of the pressure equipment according to another

the legal rules relating to the revision of the pressure.



(4) the person conducting the review of the medical device, which

is the gas device, is required to ensure that the revision of the gas equipment

was carried out by workers who meet the requirements for professional

eligibility for the implementation of the revision of the gas devices according to another

the legal rules relating to the revision of the gas.



TITLE X



VIGILANCE SYSTEM



§ 69



General provisions



(1) the vigilance System means a system for reporting and evaluation

adverse events and safety corrective measures relating to the

medical devices.



(2) adverse event shall mean



and) any failure or deterioration in the characteristics or the effectiveness of the

medical device or inaccuracy in the labelling of medical

resource, or in the instructions for use which led to or might lead to a

the death of the user or other natural persons or to a serious deterioration of their

the State of health,



(b)) technical or medical reason connected with the characteristics or

the effectiveness of the medical device manufacturer and leading for the reasons referred to in

(a)), leading to systematic recall of medical device

the same type of market.



(3) a safety remedy means measures laid down

by the manufacturer in order to reduce the risk of death or serious deterioration in the health

the State in connection with the use of a medical device, which has already been

placed on the market.



(4) a safety warning means a communication intended to distributors,

importers, users or patients, which sends the manufacturer or

authorized representative as information about the adopted security correctional

the measures.



section 70



Notification of adverse events and suspected adverse incident



(1) the manufacturer or the authorised representative shall notify the

Institute of unwanted incident related to his medical device,

and it immediately, but not later than 15 days from the date of the findings of this

the event.



(2) the importer, the distributor, the provider of health services, the person

conducting the service, the picking list and the seller shall be obliged to notify the

the manufacturer, or authorised representative and the Institute suspected adverse

incident, which arose in connection with the use of medical

resource in the provision of health services, and it shall, without delay,

However, at the latest, within 15 days from the date of the event.



(3) the notification referred to in paragraphs 1 and 2 shall



and set the notifier) data on the administrative regulations,



(b)) identification data of the medical device,



(c) the name, business name) or the name of the manufacturer and the address of its registered office, if the

It is known to the notifier,



(d) a description of the adverse events and) place and date of its establishment,



e) result in adverse events and



(f) a description of the measures taken in) the emergence of adverse events or the communication,

the measures adopted did not.



(4) if the Institute notice of suspected adverse

incident, which should take place in connection with the use of medical

resource in providing health services, or the information

finds from the official activities, then this report without undue delay

the fact the manufacturer or authorised representative.



section 71



Investigation of adverse events



(1) in the event that the manufacturer learns about the suspected adverse incident

shall immediately initiate an investigation adverse events; about this fact

shall inform the Institute.



(2) the Institute shall monitor the progress of the investigation of adverse events by the manufacturer

and evaluates all the preventive and corrective measures taken or

considered by the manufacturer. If necessary, the Institute conducts its own investigation. in

the framework of this investigation, the Department is authorized to carry out the monitoring concerned

medical devices and related documentation for persons

working with these medical devices.



(3) the manufacturer or the authorised representative shall be obliged to send to the Institute

the final report on the results of investigation of adverse events. Final

reports on the results of the investigation of adverse events includes



and medical device identification data),



(b) the name, business name) or the name of the manufacturer and the address of its registered office,



(c) the results of the investigation and the)



(d) adopted and information) under consideration.



(4) as soon as the Institute delivered the final report on the results of the investigation

adverse events, the Department will review this report with a view to ensuring

the safety and health of users, patients and other individuals.

If the Department finds that the corrective measures taken by the manufacturer of the safety

are not sufficient, then after consulting the manufacturer shall inform the Ministry,

which shall take the necessary measures to ensure the safety and health of

users, patients and other individuals and minimize options

repeated occurrence of adverse events.



(5) the Institute shall without undue delay inform the Commission,

the competent authorities of the Member States and the competent authorities of foreign States on the

the measures taken or being considered by the Institute or by the manufacturer,

the Ministry in order to minimize the recurrence of adverse incidents,

including information about these incidents. Information to users

sent out by the manufacturer, authorised representative or distributor in

the measures to minimize the recurrence of undesirable

the Institute shall publish the events through the registry of medical

resources.



(6) notification of adverse events and suspected adverse events

under section 70, paragraph. 1 and 2, information about their investigation referred to in paragraph 1 and

reports on the results of the investigation referred to in paragraph 3 shall be submitted via the

the form. The form referred to in the first sentence, the way their sending of the Institute,

the range of information about the investigation and evaluation of adverse

events and suspected adverse events lays down detailed legal

prescription.



section 72



Registration of adverse events



(1) the provider of health services, for which there was an adverse

the incident leading to the injury or death of the patient is required to

to record this fact in the medical literature conducted by

the patient.



(2) the Institute keeps track of all adverse events, leads and keeps

documentation of their investigation after a period of 15 years; in the case of adverse events

associated with injury to the health or death of a patient, user or other

natural persons shall keep the Institute of documentation for a period of 30 years.



section 73



The obligations of the provider of health services



Provider of health services, for which there has been a suspicion of

adverse incident of the medical device, it is required to



and) do all necessary measures in order to minimise the negative

impacts arising from events and inform the manufacturer or the authorised

the representative of the Institute, and



(b) make available to the manufacturers or the Institute), a medical device for which the

There has been a suspected adverse incident, including all of the documentation for the

the purpose of the inspection and the detection of the causes of events and the
(c)) to provide manufacturers and Institute all the necessary synergies and

information in order to determine the causes of the events.



§ 74



Safety corrective actions



(1) if there is an adverse incident, the manufacturer is obliged to assess the risks

with regard to the safety and health of users, patients, and other

natural persons, and, where necessary, provides security remediation

the measures. The manufacturer can provide for corrective measures and security of

other than in the context of the adverse event, if it considers it in

needed.



(2) the manufacturer or his authorized representative established in the territory of the Czech Republic

the Institute is obliged to announce the determination of the safety of the remedy

including the security warning in the Czech and English language, and

inform the competent security remedial action specified

the authorities of the States in which the medical device was delivered to the market.



(3) the manufacturer is obliged to ensure the implementation of established security

the remedial measures.



(4) the manufacturer is obliged to inform the Institute about the completion of the stated

the safety of the remedy, including information on its effectiveness,

no later than 10 days from the date of its completion.



(5) the notification referred to in paragraph 2 shall be submitted via the form.

The form referred to in the first sentence, the way his sending of the Constitution and the basic

the requirements for establishing safety remedial measures and

safety instructions laid down detailed legal prescription.



§ 75



The obligation of the importer, the Distributor and the person performing the service



The importer, the distributor and the person performing the service are required to



and perform safety corrective action) specified by the manufacturer or

The Institute,



(b) send information about Institute) set security correctional

measures and precautions in the Czech language, and no later than

10 days from the date of their receipt,



(c) notify the Institute complete set) security remediation

the measures, and not later than 10 days from the date of its completion.



TITLE XI



The REMOVAL of



§ 76



(1) with regard to the protection of life and health of humans or of animals and the protection of

the environment a person is handling a medical device

required to remove any medical device, which can be

compromised or affected its efficiency as a result of



and the violation of the conditions of storage,)



(b) the expiry of the period of its application),



(c)) violation of his original packaging, or the absence or

unreadable label, before delivery to the user, or



d) deterioration of its technical condition.



(2) for the removal of a medical device shall, in accordance with the

another legal provision governing the handling of wastes and in accordance

with the manufacturer's instructions.



TITLE XII



NATIONAL INFORMATION SYSTEM AND MEDICAL DEVICES REGISTRY

MEDICAL DEVICES



§ 77



National information system for medical devices



(1) the national information system of medical devices is the single

national public administration information system designed to



and provision of information to the users) to patients and providers

health services in order to facilitate the proper choice of appropriate medical

resource, safe use, proper handling and servicing



(b)) for the purchase of tender support medical devices,



(c) provision of information on the security) of the remedial measures and

safety warnings,



(d) obtaining the necessary data) for statistical purposes, in the range specified

other legislation, including the provision of information for the international

institutions,



(e) provision of information for the needs of) science and research in the field of

medical devices,



(f)) support the fulfilment of the obligations of the Czech Republic related to the transfer of

data into the Eudamed.



(2) the administrator of the national information system for medical devices

is the Institute.



(3) the contents of the national information system of medical devices is



and publicly accessible to) the website of the Institute within the scope of the data

on medical devices, with the exception of the data, which are subject to the protection of

under other legislation,



(b) authorized employees of the Ministry) available, and in order to

the performance of State administration in the field of medical devices,



(c)) available to eligible employees of the Institute, for the purpose of

State administration in the field of medical devices,



(d)) available to the authorised personnel of the Office for technical standardisation,

Metrology and testing, and only to the extent of the data

provided by the notified persons established in the Czech Republic, and



e) available to eligible employees health insurance, and in

the extent of the data required to ensure the performance of their duties

arising from the legislation governing public

health insurance.



(4) the data are the national health information system

funds transferred from the registry of medical devices and from the administrative

the activities of the Ministry and the Institute.



(5) the national information system and medical devices Registry

medical devices are interconnected, and the data in them led

is it possible to bring together.



(6) access rights to the information held in the national information system

medical resources to the bodies referred to in paragraph 3 (b). (b))

(e) on the basis of the Institute) to ensure their application.



Registry of medical devices



§ 78



(1) the registry of medical devices is a public information system

the Administration intended to collect data on the



and) medical devices placed on the market in the Czech Republic,



(b) persons registered under this) of the Act,



c) incidents and the corrective measures,



(d)) carried out clinical trials of medical devices,



(e)) carried out the performance evaluation of medical devices

and



f) certificates notified persons established in the Czech

Republic.



(2) the administrator of the registry of medical devices is a Ministry that

may delegate its Management Institute.



(3) the information in the registry of medical devices are managed for

the purpose of the



and) fulfilment of the obligations of the Czech Republic related to the forwarding of data

into the Eudamed,



(b) the provision of information to the public),



(c)), providing information on adopted safety corrective

measures to be taken.



(4) in the framework of the registry of medical devices, medical

resources broken down into groups of several levels. Structure

medical devices laid down detailed legal prescription.



section 79



(1) the registry of medical devices is



and publicly accessible on Internet) pages in the range of data on the

medical devices with the exception of the information subject to protection

under other legislation,



(b)) accessible to persons acting as their obligations through the registry

medical devices and persons acting on the basis of the full

power, and it's in the range of data on their person and in a range of data about them

notified medical devices,



(c)) available to the authorised personnel of the Ministry, and for the purpose of

the performance of State administration in the field of medical devices,



(d)) available to the authorised personnel of the Institute, and for the purpose of

State administration in the field of medical devices,



e) available to the authorised personnel of the Office for technical standardisation,

Metrology and testing, and only to the extent of the data

provided by the notified persons established in the Czech Republic, and



(f)) available to authorized employees health insurance, and only

the extent of the data required to ensure the performance of their duties

arising from the legislation governing public

health insurance.



(2) the Notified person established on the territory of the Czech Republic is obliged to

Registry of medical devices to upload information about her published,

modified, supplemented, suspended or withdrawn certificates, as well as

a refusal to issue the certificate.



(3) every person who is referred to in this law shall be entitled to provide or

the information in the registry of medical devices, has access to the data in the

the extent to which it is provided.



(4) the data kept in the registry of medical devices that are subject to

protection under the law governing the protection of personal data and the law

adjusting the free access to information, are closed to the public, other

the data are published by the registry of medical

resources.



(5) the access rights to the data held in the register of medical

means the operators referred to in paragraph 1 (b). (b) to (f))) the Institute shall ensure that

on the basis of their application.



TITLE XIII



CHECK



§ 80



(1) Control of the fulfilment of the obligations under this Act by the persons

operators of medical devices shall control

the order of the Institute.



(2) Checking whether they are medical devices marketed and delivered to the

in the Czech Republic market or put into service in accordance with the technical

requirements under the Act shall be exercised by adjusting the technical requirements for

products and the control of the order of the Institute.



(3) the credentials to control takes the form of a licence.
(4) the Institute may decide on suspension or termination of use

the medical device, if the use of such a device

or in connection with the imminent risk of injury to health

natural persons. Appeals against this decision does not have suspensory effect.

The costs associated with the implementation of the decision shall be borne by the provider of the health

services.



TITLE XIV



ADMINISTRATIVE OFFENCES



§ 81



Administrative delicts of legal entities and natural persons engaged in the field of

clinical tests and performance evaluation



(1) the sponsor clinical trials has committed misconduct by

initiates clinical trial in contravention of section 15(1). 1 or makes changes

the conditions of clinical trials in contravention of section 15(1). 4.



(2) the provider of health services has committed misconduct by

the clinical test for a person who does not meet the conditions referred to in

section 13 (3). 1 (a). and).



(3) the provider of health services has committed misconduct by

the clinical test in contravention of section 15(1). 1.



(4) the sponsor clinical trials has committed misconduct by

fails to meet any of the requirements referred to in section 19.



(5) the Entrepreneurial natural person as main investigator, investigator or

committed misconduct that does not fulfil one of the obligations referred to in section

20.



(6) the contracting authority performance evaluation makes administrative

tort that does not comply with the obligation referred to in section 24.



(7) for the administrative offence is imposed in the



2 0000 0000 Czk), with respect to the administrative offence referred to in paragraphs 1 to 4,



b) 500 000 CZK in the case of an administrative offence under paragraphs 5 and 6.



section 82



Misdemeanor in clinical trials



(1) a natural person as principal investigator or the investigator commits

an offence that does not fulfil one of the obligations referred to in section 20.



(2) for the offence referred to in paragraph 1 may be fine to 500 000 Czk.



section 83



Administrative delicts of legal entities and natural persons engaged in the performance of

the obligation to



(1) the manufacturer or his authorized representative established in the Czech Republic,

the importer, the distributor, the person performing the service or sponsor a clinical

the test applied to the territory of the Czech Republic committed by administrative tort

by performing the relevant activities without compliance with the obligation to

in accordance with section 26.



(2) the manufacturer or his authorized representative established in the Czech Republic,

the importer, the distributor, the person performing the service, clinical

tests, or notified the person commits misconduct by



and in fulfilment of the obligation) under section 26 shall indicate false information,



(b)) when you change the data does not report this change to the Constitution within the time limit under section 29.

3.



(3) for the administrative offence is imposed in the



1 0000 0000 Czk), with respect to the administrative offence referred to in paragraph 1,



b) 500 000 CZK in the case of an administrative offence referred to in paragraph 2 (a). and)



(c)) 200 000 CZK in the case of an administrative offence referred to in paragraph 2 (a). (b)).



§ 84



Administrative delicts of legal entities and natural persons engaged in the

medical device notification pursuant to § 31 of the



(1) the manufacturer or his authorized representative established in the Czech Republic

committed misconduct by



and the absence of the Institute a request for) the notification of the medical device within

in accordance with section 31, paragraph. 1,



(b) false information) in a request for notification of the medical

resource submitted pursuant to § 32 paragraph. 2, or



(c)) when you change the data referred to in the absence of the notification of the Institute within the application

According to § 35 paragraph. 4.



(2) for the administrative offence is imposed in the



1 0000 0000 Czk), with respect to the administrative offence referred to in paragraph 1 (b). and)



b) 500 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (b)),



(c)) 200 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (c)).



§ 85



Administrative delicts of legal entities and natural persons engaged in the

medical device notification according to § 33



(1) the Distributor or the importer of a medical device marketed

The Czech Republic has committed misconduct by



and the absence of the Institute a request for) the notification of the medical device within

According to § 33 paragraph. 1,



(b)) does not report the Institute fact pursuant to section 33, paragraph. 2,



(c)) shall indicate false information in the application for notification of the medical

resource submitted pursuant to § 34 paragraph. 2, or



(d)) when you change the data referred to in the absence of the notification of the Institute within the application

According to § 35 paragraph. 4.



(2) for the administrative offence is imposed in the



and 500 000 CZK), with respect to the administrative offence referred to in paragraph 1 (b). and (b)),)



b) 200 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (c)), and (d)).



§ 86



Administrative delicts of legal entities and natural persons engaged in the field of

distribution, import, and sale of issues



(1) the Distributor commits misconduct by distributing

medical device in contravention of section 43 (a). and), b), c) or (d)).



(2) the Distributor or importer has committed misconduct by



and) distributes or imports a medical device in contravention of section 45

paragraph. 1, or



b) violate any rule of good distribution and import practices by

section 45, paragraph. 2.



(3) the picking list commits misconduct by



and) violates any of the requirements of section 49,



(b)) when a mail order medical device issue, breach of an obligation

According to § 50 paragraph. 3,



(c)) violates any of the duties referred to in section 54,



(d)) shall issue a medical device in violation of § 55 paragraph. 1 (a). and (b)))

(c)), or (d)), or



(e)) will not provide under section 55, paragraph. 2, to medical devices, which

they were taken out of the issue, have been stored separately from medical

the funds, which can be issued.



(4) the seller has committed misconduct by



and sells a medical device) in violation of § 56 paragraph. 1,



(b) fails to fulfil any of the obligations) pursuant to § 56 paragraph. 2,



c) sells a medical device in contravention of section 57, paragraph. 1 (a). and (b)))

(c)), or (d)), or



(d)) will not provide under section 57, paragraph. 2, to medical devices, which

were excluded from the sale, have been stored separately from medical

means that you can sell.



(5) the Legal or natural person established by the administrative

tort by



and the consumer) will provide a medical device referred to in section 46 paragraph. 2

without the card,



(b) provide to the consumer) medical device referred to in section 46 paragraph.

2, without having fulfilled the requirements set out in § 49 paragraph. 2, or



(c)) at a mail order medical device issue, breach of an obligation

According to § 50 paragraph. 2 or 3.



(6) for the administrative offence is imposed in the



and 200 000 CZK), with respect to the administrative offence referred to in paragraph 2 (a). and)

paragraph 3 (b). (e)) and paragraph 4 (b). (d)),



b) 500 000 CZK in the case of an administrative offence referred to in paragraph 1, paragraph 2

(a). (b) paragraph 3 (b)). and (c))), or (d)) and paragraph 4 (b). and (b)))

or (c)),



(c)) 1 0000 0000 CZK in the case of an administrative offence under paragraph 3 (b). (b)) or

paragraph 5.



§ 87



Misdemeanor in the prescribing



(1) a natural person has committed the offence by exposing medical

the prescription, that is, without the person referred to in section 46 paragraph. 1.



(2) a natural person as an employee who performs the medical

the professions of doctor, commits an offence that does not comply with any of the

obligations pursuant to § 47 odst. 1 or 2 or section 48 paragraph. 1.



(3) can impose a fine for the offense to



and 200 000 CZK), if the offence referred to in paragraph 1,



(b)) 100 000 CZK in the case of a misdemeanour provided for in paragraph 2.



section 88



Administrative delicts of legal entities and natural persons engaged in the field of

the prescription



(1) Legal or natural person established by the administrative

tort by exposing medical prescription, that is, without

the person referred to in section 46 paragraph. 1.



(2) the Entrepreneurial natural person who performs the medical profession

the doctor is guilty of misconduct that does not comply with any of the

obligations pursuant to § 47 odst. 1 or 2 or section 48 paragraph. 1.



(3) for the administrative offence is imposed in the



and 500 000 CZK), with respect to the administrative offence referred to in paragraph 1,



(b)) 100 000 CZK in the case of an administrative offence referred to in paragraph 2.



§ 89



Administrative delicts of legal entities and natural persons engaged in the field of

the use of the



(1) the provider of health services has committed misconduct by

that



and medical device) use in contravention of section 58,



(b) fails to comply with any of the requirements), pursuant to section 59 paragraph. 1, 3 or 4,



(c)), that the user does not provide the available instructions for use in accordance with section 60,



(d)) apply in the provision of health services medical device in

contrary to section 59 paragraph. 2, or



(e)) does not ensure that the



1. a person who operates a medical device,

education under section 61, paragraph. 1,



2. the briefing engaged the person meeting the requirements under section 61, paragraph. 2,

or



3. have been kept and maintains information about all your instruktážích

under section 61, paragraph. 3.



(2) for the administrative offence is imposed in the



1 0000 0000 Czk), with respect to the administrative offence referred to in paragraph 1 (b). and) or

(d)),



b) 500 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (b)),



(c)) 200 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (c)), or

(e)).



§ 90



Administrative delicts of legal entities and natural persons engaged in the field of

service



(1) the provider of health services has committed misconduct by

that does not make the implementation of the technical maintenance of the medical device in

the extent and frequency according to section 65 paragraph. 3.



(2) the Legal or natural person, operating as the person performing the
Service commits misconduct that does not ensure compliance with some of the

obligations under section 65 paragraph. 4.



(3) the provider of health services has committed misconduct by

contrary to section 65 paragraph. 5 does not or does not retain the registration carried out by the

service after the statutory period of time.



(4) the Legal or natural person, operating as the person performing the

Service commits misconduct that does not ensure compliance with some of the

obligations under section 66 paragraph. 2 or 3.



(5) for the administrative offence is imposed in the



and 500 000 CZK), with respect to the administrative offence referred to in paragraph 1, 3, or 4



(b)) 300 000 CZK in the case of an administrative offence referred to in paragraph 2.



§ 91



Administrative delicts of legal entities and natural persons engaged in the field of

adverse events



(1) the manufacturer, the authorised representative, distributor, importer, service provider

health services, the person performing the service, picking list or seller

is guilty of misconduct by the Institute notifies in writing

the fact within the time limit under section 70, paragraph. 1 or 2.



(2) the provider of health services has committed misconduct by

that fail to comply with the obligation under section 72, paragraph. 1.



(3) the provider of health services has committed misconduct by

that fail to comply with the obligation under article 73 (e). (b)).



(4) the manufacturer or the authorised representative commits misconduct

that fail to comply with the obligation under section 74, paragraph. 2.



(5) the manufacturer has committed misconduct that does not comply with the obligation to

under section 74, paragraph. 4.



(6) the importer, the distributor or the person performing the service commits

the administrative tort by fails to fulfil any of the obligations under section 75.



(7) for the administrative offence is imposed in the



and 500 000 CZK), with respect to the administrative offence referred to in paragraph 1, 3 or 6,



b) 200 000 CZK in the case of an administrative offence referred to in paragraph 2, 4, or 5.



section 92



Common provisions in administrative deliktům



(1) a legal person and a natural person-entrepreneur behind the administrative tort

does not match, if the shows that made every effort, which was

may be required to prevent the breach of legal obligations.



(2) in determining the acreage of the fine legal person and entrepreneurial natural

the person shall take into account the seriousness of the misconduct, in particular to the way

his committed and its consequences, and the circumstances under which it was committed.



(3) liability of legal persons and entrepreneurial natural persons in administrative

tort shall cease, if the administrative authority has commenced proceedings about him within 2 years

from the date on which it learned, but not later than 5 years from the date on which the

has been committed.



(4) administrative offences under this Act are heard by the Institute.



(5) the Fines collected by the authority which is saved.



(6) income from fines is the income of the State budget.



TITLE XV



COMMON, TRANSITIONAL AND FINAL PROVISIONS



Part 1



Common provisions



§ 93



Accessories and additional use of medical devices



(1) on the Accesories of the medical device and those with him

handling the provisions of this Act, setting out the requirements

on medical devices and on persons handling medical

Similarly, resources.



(2) the requirements for the provision of health services

through the medical resource, that are contained in the

titles VIII, IX and X, apply mutatis mutandis to persons

through medical device risk class IIa, IIb or

(III) provide other services than health.



Reimbursement of expenses



§ 94



(1) for the performance of professional acts at the request of the applicant is obliged to Institute

pay the reimbursement of expenses. For professional tasks, in particular, shall be considered as

drawing up expert opinions or opinions.



(2) the person handling medical devices, is required to pay

refunds of expenditure for the operations of the Institute, the United



and with the authorization of clinical trials) and changes in the conditions of clinical trials and



(b)) with the release of a certificate of free sale.



(3) the amount of reimbursement for professional acts referred to in paragraphs 1 and 2 shall provide for

the implementing legislation.



section 95



(1) the person on whose application the technical operations to be performed, shall be obliged to

The Institute to pay the appropriate deposit in advance if it is obvious that technical operations

will be carried out.



(2) the Institute returns to the applicant



and) reimbursement of expenses in full, if



1. the applicant has paid the reimbursement without was obliged to, or



2. the Professional operation has not started, or



(b)), at its request, a proportion of the reimbursement of expenses paid by the corresponding

Professional acts were not carried out.



(3) the reimbursement of expenses under section 94 are not income of the State budget according to the

the law governing the budgetary rules ^ 7), the income of the Institute and are

kept in a special account. The Institute uses these resources solely for the

ensure your activities carried out under this Act or under other

the legislation, if this activity to the extent necessary to ensure the

the budgetary resources.



Part 2



The enabling provisions



section 96



(1) the Government shall issue the regulations for the implementation of section 5 (a). l), section 6 (1). 1 and section 24.



(2) the Ministry shall issue a decree for the implementation of section 6 (1). 2, section 19, paragraph. 2

(a). n), section 45, paragraph. 2, § 46 paragraph. 2, § 48, paragraph. 3, § 56 paragraph. 2 (a).

and, section, paragraph 59). 4, § 71 paragraph. 6, section 74, paragraph. 5, section 78, paragraph. 4 and § 94 paragraph.

3.



Part 3



Transitional provisions



§ 97



(1) a clinical examination of the medical device initiated before the date of

the entry into force of this law, and to this day the unfinished completes and

the rights and obligations related thereto shall be assessed in accordance with the existing

the legislation.



(2) the provider of health services, which was prior to the date

the effectiveness of this law established the Ethics Committee, for the purpose of the implementation of the

clinical trials of medical devices, shall, within 30 days from the

date of entry into force of this Act, to send information about the establishment of the Institute

the Ethics Commission and its current composition.



(3) the person handling medical devices,



and which announced his Ministry) the activity referred to in section 31, paragraph. 2 of the Act

No 123/2000 Coll., on medical devices and on the amendment of certain

related laws, is considered as a person registered under section 26.

The Ministry is obliged to provide all information to the notified

Medical devices registry not later than 3 months from the date of

the entry into force of this law. The person referred to in the first sentence is required to

up to 1 year from the date of entry into force of this Act may submit a request to the Institute

renewal of authorization under section 29. If the person referred to in the first sentence in the

1 year from the date of entry into force of this Act, have not made a request for

the extension of the registration, the cancellation of the registration of that person, the Institute of

Registry of medical devices,



(b)) which is subject to the reporting requirements under section 26, performs its activity

After the date of entry into force of this law and that before the date of entry into

the effectiveness of this law did not report their activities, in accordance with section 31, paragraph. 2

Act No. 121/2000 Coll., is required to submit within a period of 1 year from the date of acquisition

the effectiveness of this Act the application for marketing authorization pursuant to § 29 of this Act.



(4) a medical device, the manufacturer or his authorised

representative established in the territory of the Czech Republic announced the Ministry properly after

31. March 2011 under section 31, paragraph. 1 of Act No. 123/2000 Coll., shall be deemed to

for medical device notified under section 31. The Ministry is

required to provide all of the data in the registry reported

medical devices no later than 3 months from the date of acquisition

the effectiveness of this Act. The manufacturer or his authorized representative established in the

the territory of the Czech Republic shall, within 1 year after the date of entry into force

This law confirmed through medical Registry

means the validity of reported data referred to in the notice, or

Add missing mandatory information set out in section 32, and submit an application for

the extension of the notification. If the manufacturer or the authorised representative of

established on the territory of the Czech Republic to 1 year from the date of entry into force of

This law does not acknowledge the validity of the data referred to in the notification, the phrase

missing required information or fails to file a request for extension of the notification, the

the Institute performs the erasure from the register of medical device medical

resources.



(5) the Distributor or importer who has fulfilled its reporting obligation

According to Act No. 121/2000 Coll. and intends to continue to disclose or supply on the

the market in the Czech Republic medical device which stated or added

on the market in the Czech Republic before the date of entry into force of this Act, and

that is subject to the obligation of notification according to § 33 shall be obliged to submit an application

notification of this medical device no later than



and) 1 year after the date of entry into force of this Act in the case of

risk class III medical device or the active

implantable medical device,



(b)) 2 years from the date of entry into force of this Act in the case of

medical device risk class IIb or diagnostic

in vitro medical device belonging to the list A or B,



c) 3 years after the date of entry into force of this Act in the case of

medical device risk class IIa or medical

the device for self-testing.



(6) on an application submitted in accordance with paragraph 5 shall be decided by the Institute

not later than 90 days from the date of submission of the application.



(7) Any certificate of compliance with the requirements for the placing of the medical
device on the market in the Czech Republic or other certificate having a similar

character as a certificate of free sale according to § 37 issued

the Ministry before the date of entry into force of this Act are valid for

period of 1 year from the date of entry into force of this Act.



§ 98



(1) a medical device shall be issued on the basis of a medical prescription

issued before the date of entry into force of this Act, in accordance with the existing

the legislation.



(2) in the case of instruction under section 61, paragraph. 2 it is possible for the medical

the resource whose manufacturers have already disappeared, replace the lessons by the manufacturer

the lesson from the person who has the use of the medical

resource of at least five years ' experience.



(3) a medical device that is CE marked and which

was put into service before the date of entry into force of this Act in the

accordance with section 52 of the Act No. 121/2000 Coll., can also be used when

compliance with the other conditions laid down in this law for the use of

medical devices.



(4) for a period of 2 years from the date of entry into force of this law may support

maintenance carried out, the person who does not meet the requirements set out in section 65 paragraph.

4 (b). and (b)),) and if this activity carried out prior to the date

the effectiveness of this law in accordance with the law No. 121/2000 Coll.



(5) the investigation of adverse events reported in accordance with section 32 of the Act

No 123/2000 shall be completed according to the existing legislation.



(6) Control initiated by the Institute before the date of entry into force of this Act

pursuant to section 42 of the Act No. 121/2000 Coll., completes the existing legal

regulations.



(7) Check initiated by the Czech commercial inspection prior to the date

the effectiveness of this law, whether they are medical devices marketed and

placed on the market or put into service in accordance with the technical requirements, and whether the

are not improperly equipped with relevant CE marking, and to this day been

the unfinished, completed according to the existing legislation. The management of the

administrative offenses committed before the date of entry into force of this

the law in the area of medical devices according to the law governing the

technical requirements on products as shall be discussed by the Czech trade inspection

the existing legislation.



(8) proceedings for administrative offences, initiated by the Institute before the date of entry into

the effectiveness of this law, and to this day been the unfinished,

completes the existing legislation.



Part IV



Final provisions



§ 99



(1) if it is not on the market of the corresponding medical device that meets the

the requirements of this Act and the Act relating to the technical requirements for

products, the Ministry in case of serious threats to human life

or, exceptionally, at the request of the health provider of health

the use of the services of the medical device, these requirements

does not meet; This request must be duly substantiated. On the procedure for

deciding on the authorisation referred to in the first sentence shall not apply the administrative code.



(2) To permit exceptions is not a legal right.



§ 100



Confidentiality



(1) persons who provide and carry out clinical trials

medical devices, members of ethics committees, the person

provide and carry out investigation of adverse events, inspectors

carrying out control activities in accordance with this law and the relevant

staff of the Institute and the Ministry are required to maintain the confidentiality of any

confidential information learned in carrying out its tasks

arising from this Act. This does not affect the obligations with regard to

the mutual information of the public authorities and the dissemination of warnings, nor the

the obligations of the persons concerned to provide information under criminal law.



(2) confidential information shall not be considered fact



and) relating to the registration of persons and notification of medical devices,



(b)) was by the manufacturer, authorised representative or distributor in

the measures to minimize the recurrence of undesirable

events and



(c)) contained in certificates issued, modified, supplemented, suspended or

withdrawn certificates.



§ 101



This law has been notified in accordance with the directive of the European Parliament and of the

Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision

information in the field of standards and technical regulations and regulations for services

the information society, as amended.



Part 5



Cancellation provisions



§ 102



Shall be repealed:



1. Act No. 121/2000 Coll., on medical devices and on the change

some of the related laws.



2. the first Part of Act No 130/2003 Coll., amending Act No. 123/2000

Coll., on medical devices and on the amendment of certain related

laws, and some other laws.



3. Section 17 of the Act No. 274/2003 Coll., amending certain laws

in the field of the protection of public health, and some other laws.



4. the first Part of Act No. 58/2005 Coll., amending Act No. 123/2000

Coll., on medical devices and on the amendment of certain related

laws, as amended, and Act No 455/1991 Coll., on the

trades (Trade Act), as amended

regulations.



5. the second part of the 1990s Act No 227/2009 Coll., amending certain

laws in connection with the adoption of the law on basic registers.



6. Law No 196/2010 Coll., amending Act No. 123/2000 Coll., on the

medical resources and on the amendment of certain related laws

in the wording of later regulations.



7. Part of the forty-eighth law No 375/2011 Coll., amending certain

laws in connection with the adoption of the law on health services, the law on the

specific health services and the health emergency Act

the service.



8. Government Decree No 342/2000 Coll., laying down the health

resources that can threaten human health.



9. Government Regulation No 154/2004 Coll., laying down the technical

requirements for active implantable medical devices and

Regulation of the Government No. 251/2003 Coll., amending certain regulations

the Government issued for the implementation of law No. 22/1997 Coll., on technical

requirements for products and amending and supplementing certain acts, as amended by

amended.



10. Government Regulation No. 307/2009 Coll., amending Decree-Law No.

154/2004 Coll., laying down technical requirements for active

implantable medical devices and amending the regulation of the Government

No 251/2003 Coll., amending certain regulations issued by the Government to

implementation of the law No. 22/1997 Coll., on technical requirements for products and

amending and supplementing certain acts, as amended.



11. Government Regulation No. 66/2011 Coll., amending Decree-Law No.

154/2004 Coll., laying down technical requirements for active

implantable medical devices and amending the regulation of the Government

No 251/2003 Coll., amending certain regulations issued by the Government to

implementation of the law No. 22/1997 Coll., on technical requirements for products and

amending and supplementing certain acts, as amended, in

amended by Decree-Law No 307/2009 Sb.



12. Decree-Law No 336/2004 Coll., laying down the technical

requirements for medical devices and amending Government Ordinance No.

251/2003 Coll., amending certain regulations issued by the Government for the implementation of

Act No. 22/1997 Coll., on technical requirements for products and amending and

supplementing certain acts, as amended.



13. the regulation of the Government No. 212/2007 Coll., amending Decree-Law No.

336/2004 Coll., laying down technical requirements for medical

resources and amending Government Decree No. 251/2003 Coll., amending

amending certain regulations issued by the Government to the implementation of the law No. 22/1997 Coll., on

technical requirements for products and amending and supplementing certain

laws, as amended.



14. Government Regulation No 245/2009 Coll., amending Decree-Law No.

336/2004 Coll., laying down technical requirements for medical

resources and amending Government Decree No. 251/2003 Coll., amending

amending certain regulations issued by the Government to the implementation of the law No. 22/1997 Coll., on

technical requirements for products and amending and supplementing certain

laws, as amended by later regulations, as amended by Decree-Law No.

212/2007 Sb.



15. Government Regulation No. 65/2011 Coll., amending Decree-Law No.

336/2004 Coll., laying down technical requirements for medical

resources and amending Government Decree No. 251/2003 Coll., amending

amending certain regulations issued by the Government to the implementation of the law No. 22/1997 Coll., on

technical requirements for products and amending and supplementing certain

laws, as amended, as amended.



16. Decree-Law No 453/2004 Coll., laying down the technical

requirements for in vitro diagnostic medical devices.



17. the regulation of the Government No. 246/2009 Coll., amending Decree-Law No.

453/2004 Coll., laying down technical requirements for diagnostic

in vitro medical devices.



18. Government Regulation No. 67/2011 Coll., amending Decree-Law No.
453/2004 Coll., laying down technical requirements for diagnostic

in vitro medical devices, as amended by regulation of the Government No. 246/2009

SB.



19. Government Regulation No. 223/2012 Coll., amending Decree-Law No.

453/2004 Coll., laying down technical requirements for diagnostic

in vitro medical devices, as amended.



20. Decree No 316/2000 Coll., laying down the requirements of the final

reports on the clinical evaluation of the medical device.



21. Decree No 501/2000 Coll., laying down the forms, methods

reporting of adverse events of medical devices, their

registration, investigation and evaluation, documentation and preservation and

follow-up with a view to the prevention of adverse events,

in particular, their recurrence (Decree on incidents

medical devices).



22. Decree No. 304/2003 Coll., amending Decree No 501/2000 Coll.

laying down the forms, methods of reporting adverse events

medical devices, their registration, investigation and evaluation,

documentation and its retention and follow-up with a view to the prevention of

the emergence of adverse events, particularly their recurrence (the Decree on the

adverse events of medical devices).



23. Decree No 356/2001 Coll., on the authorisation of exemptions from compliance with the

technical requirements on medical device for use in the

the provision of health care and the extent of the published data on their

the authorization.



24. Decree No. 11/2005 Coll., which sets out the types of medical

funds with an increased risk for users or third parties and the

monitoring of these funds, after placing them on the market.



25. Decree No. 100/2012 on the prescribing of medical devices

and on the conditions for dealing with them.



PART THE SECOND



Amendment of the Act on administrative fees



section 103



In item 97 of annex to the Act No 634/2004 Coll., on administrative fees,

the following point 3 is added:



"3. The adoption of the



and requests for notification or) extension

notification of serially produced by the medical

the device or accessories of the medical

resource placed on the market by the manufacturer or

authorized representative of Czk 500



request for change notifications in series

produced by medical device or

medical device accessories

placed on the market by the manufacturer or

authorised representative Czk 50



(b) notification of the activities of the producer series)

the manufactured medical devices Czk 2 500

the manufacturer individually made

medical devices Czk 2 500

authorised representative, according to the law

Czk 2 500 on medical devices

distributor of medical devices Czk 2 500

the person performing the service of health

Czk 2 500 resources

importers of medical devices Czk 2 500

sponsor clinical trials

medical device Czk 2 500



(c)) the applications for authorisation of clinical trials

medical device Czk 500



(d) a certificate request) free

the sale of the medical device is CZK 500.



PART THE THIRD



The EFFECTIVENESS of the



section 104



This law shall enter into force on 1 January 2005. April 2015, with the exception of the provisions

section 9 (a). (d)) and section 77, which shall take effect on 1 January 2005. April 2018.



In r. hamáček.



Zeman in r.



Sobotka in r.



1) Council Directive 93/42/EEC of 14 June 1993. June 1993 on medical

of transport, as amended. Council Directive 90/385/EEC of 20 December.

June 1990 on the approximation of the laws of the Member States relating

active implantable medical devices, as

the text of the. European Parliament and Council Directive 98/79/EC of 27 June 2002. October

1998 on in vitro diagnostic medical devices, as

the text of the. Commission decision 2010/227/EC of 19 June 2000. April 2010 on the European

database of medical devices (Eudamed).



section 13, paragraph 2). 3 of Act No. 22/1997 Coll., on technical requirements for

products and amending and supplementing certain acts, as amended

regulations.



3) for example, the communication from the Ministry of Foreign Affairs No. 96/2001 Coll., m.

with the adoption of the Convention on the protection of human rights and dignity of the human

being in relation with the application of biology and medicine.



4) the Constitutional Act No. 110/1998 Coll., on the safety of the Czech Republic, in the

the text of the amended constitutional laws.



5) the Constitutional Act No. 1/1993 Coll., Constitution of the Czech Republic, as amended by

later the constitutional laws.



6) Act No. 219/1999 Coll., on the armed forces of the Czech Republic, in the

as amended.



7) section 6 (1). 1 of law No 218/2000 Coll., on the budgetary rules and the

changes to some related laws, as amended.