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.