54/2015 Sb.



GOVERNMENT REGULATION



of 25 June 2002. March 2015



on technical requirements for medical devices



Government orders under section 22 of Act No. 22/1997 Coll., on technical

requirements for products and amending and supplementing certain acts, as amended by

Act No. 71/2000 Coll., Act No. 204/2002 Coll., Act No. 34/2007 Coll.

Act No. 100/2013 Coll. and Act No. 64/2014 Coll. (hereinafter referred to as "the law of

technical requirements for products ") for the implementation of paragraph 2 (a). (d)), section 11

paragraph. 1, 2 and 9, section 11a. 2, section 12 and 13 of the Act on technical

requirements for products and in accordance with § 96 para. 1 of law no 268/2014 Coll.

medical devices and amending Act No. 634/2004 Coll., on

administrative fees, as amended, (hereinafter referred to as "the law of

medical devices ") to implement section 5 (b). l) and section 6 (1). 1

(a). and the law on medical devices):



§ 1



The subject of the edit



(1) this regulation incorporates the relevant provisions of the European Union ^ 1) and

regulates the technical requirements for fixed products.



(2) laid down under this regulation are products within the meaning of § 12 para.

1 (b). and) of the technical requirements for products medical

devices and their accessories.



(3) this Regulation shall not apply to



and) in vitro diagnostic medical devices and their

Accessories,



(b) active implantable medical devices).



§ 2



Definition of terms



For the purposes of this regulation, means a



and a subset of medical devices) health file

devices having a common area of the intended purpose or shared

technology,



(b)) a group of generic medical devices medical file

devices having the same or similar intended purpose or shared

the technology, which allows it to be classified generically without

taking into account the characteristics of a particular medical device.



§ 3



The General principles of



(1) a medical device shall meet the essential requirements referred to in

Annex 1 to this Regulation (hereinafter referred to as "basic requirements"), which

the specific medical device and taking account of

its intended purpose.



(2) if they are medical devices without prejudice to the other legal

the rules governing the technical requirements of the personal protective

resources ^ 2) ^ 3 and ionizing radiation), the use of these laws

It is not affected by this regulation. The basic requirements in terms of

electromagnetic compatibility are given concrete form for medical

resources in Appendix No. 1 to this regulation and in their assessment of the

not applicable government regulation, laying down technical requirements for

products in terms of their electromagnetic compatibility ^ 4).



(3) where there is a risk, the medical device which

It is also the machinery, also comply with the essential requirements of the

health and safety requirements set out in government regulation on technical

the requirements for machinery ^ 5) if it set out the basic

requirements are more specific than the essential requirements set out in this

of the regulation.



(4) the essential requirements shall be considered satisfied if a medical

the resource is in accordance with the requirements of harmonized standards ^ 6)

This medical device apply taking into account its

their intended purpose. For the purposes of this regulation includes a reference to

harmonised standards also the monographs of the European Pharmacopoeia, particularly

surgical sutures and on interaction between medicinal products and

materials used in medical devices, that these

preparations contain links which have been published in the official journal of the

Of the European Union.



§ 4



The conformity assessment procedures



(1) in the case of a medical device risk class I, which is not

individually made up a medical device or medical

device intended for clinical investigation, the manufacturer for its measures

the CE marking to be governed by the procedure laid down in annex 7 to this regulation.



(2) in the case of a medical device risk class IIa, which is not

individually made up a medical device or medical

device intended for clinical investigation, the manufacturer for its measures

the CE marking to be governed by the procedure laid down in annex 7 to this regulation in the

conjunction with the procedure laid down in



and # 4) of the annex to this regulation,



(b)) of annex 5 to this regulation, or



(c)) of annex 6 to this regulation.



Instead of the procedures referred to in points) to c) you can use the procedure described in paragraph

3 (b). and).



(3) in the case of a medical device risk class IIb, which is not

individually made up a medical device or medical

device intended for clinical investigation, the manufacturer for its measures

the CE marking to be governed by the procedure laid down in



and # 2) of the annex to this regulation, with the exception of points 8, 9 and 10, or



(b)) in accordance with annex 3 to this regulation, in combination with the procedure

According to the annex No. 4, 5 or 6 to this regulation.



(4) in the case of a medical device risk class III, that is not

individually made up a medical device or medical

device intended for clinical investigation, the manufacturer for its measures

the CE marking to be governed by the procedure laid down in



and # 2) of the annex to this regulation, or



(b)) Annex 3 to this regulation in conjunction with the procedure referred to in annex

No 4 or 5 to this regulation.



(5) before placing each individually made medical

product on the market or into service, the manufacturer shall, in accordance with Annex No. 8

to this regulation.



(6) by way of derogation from paragraphs 1 to 5, a Ministry of health on

the basis of a duly substantiated request to enable on the territory of the Czech Republic

placing on the market and putting into service of an individual medical device,

for which the procedure has not been performed in accordance with paragraphs 1 to 5 and the use of

It is in the interest of protection of health.



(7) when assessing the conformity of a medical device manufacturer,

authorized representative or notified body shall take account of the results of all

assessment and verification operations carried out, if necessary in

accordance with this regulation in the left of the production process.



(8) on the instructions of the manufacturer's authorised representative to initiate the procedure

According to annexes 3, 4, 7 and 8 of this regulation.



(9) If a conformity assessment procedure for a medical device

It includes the participation of the notified body, the manufacturer, or his authorised

representative so requests for conformity assessment by the person according to their own

selection with the corresponding scope of authorization and notification.



(10) the notified body may require, where duly justified, to request

any information or data necessary for establishing and maintaining

verification of conformity in view of the chosen procedure.



(11) the certificates issued by the certification and other decision

issued in accordance with annexes 2, 3, 5 and 6 to this regulation are

valid for a maximum period of 5 years and may be renewed for a further period in the

a maximum of 5 years, on the basis of an application submitted in time, the two

agreed in the contract signed by both parties.



(12) the documentation accompanying the medical device, the records

and correspondence relating to the procedures referred to in section 4 shall be in

Czech language or in another language acceptable to the certification

person.



(13) the conformity assessment procedures in terms of minimizing the risk of transmission

the disease transmissible spongiform encephalopathy (TSE) on a person shall be governed by

Commission Regulation 722/2012 on special requirements relating to the

the requirements set out in the Council directives 90/385/EEC and 93/42/EEC with

regard to active implantable medical devices and medical

devices manufactured utilising tissues of animal origin, as amended.



§ 5



A special procedure for systems and medical devices and kits for

implementation of sterilization



(1) for systems and kits of medical devices, section 4 shall not apply,

If it is not stipulated otherwise.



(2) any natural or legal person who puts medical

devices bearing the CE marking in order to place them on the market as a system

or in accordance with its intended purpose, shall draw up a statement in

stating that the



and he has verified the mutual compatibility of) medical devices referred to in

the instructions of their producers, and ensure that they operate in accordance with these

instructions,



(b) he has packaged the system or Kit) of medical devices and

the relevant information for the user, including instructions from the manufacturers

individual medical devices and



(c) any activity of the pertinent) methods of internal control and

inspections.



(3) are not complied with the requirements set out in paragraph 2, shall be deemed to

such a system, or a combination of medical devices under the medical

a resource that is subject to the procedure referred to in article 4.



(4) any natural or legal person who sterilised systems and

of the combination of medical devices referred to in paragraph 2 or other

CE-marked medical devices designed by their manufacturers to be

sterilised prior to use, with a view to their placing on the market, it chooses

one of the procedures referred to in annex No. 2 or 5 to this regulation. The use of the

These annexes and the activities of notified body shall be limited to the validation process


used to achieve sterility, lasting until the time of open or

damage to the sterile packaging. The person concerned shall draw up a statement in

which confirms that the sterilization has been carried out in accordance with the instructions

manufacturer.



(5) medical devices referred to in paragraphs 2 and 4 cannot be

an additional CE marking, but attached to them in accordance with the information

paragraphs 16 and 17 of annex 1 to this regulation, which contain the relevant

data producers completed medical devices. The Declaration

in accordance with paragraphs 2 and 4 shall be kept for at least 5 years

the competent administrative authorities.



§ 6



The CE Marking



(1) a medical device, with the exception of individually made

medical device and medical device intended for

Clinical exam that meets the requirements of this regulation,

before placing on the market and/or put into service, must affix the CE marking, the

graphic design provides for the directly applicable European Union ^ 7).



(2) If a medical device is the subject of the other aspects of the particular

the legislation, which lays down the obligation to affix the CE marking,

in this case, the sign that a medical device

It is in accordance with the requirements that apply to it under these

special legislation.



(3) However, if one or several of the legislation for a transitional

time concedes that the manufacturer has chosen, the provisions of which shall be governed,

CE marking shall indicate conformity only with the law, or the

their provisions applied by the manufacturer. In this case, must be in

documentation, notices or instructions required by the competent

legislation and accompanying the product, lists

used legislation and directives, as published in the

The official journal of the European Union, whose requirements were those legal

the provisions were taken.



(4) the CE marking is to be positioned in a visible, legible and indelible form on the

medical device or its sterile pack, where it is

practicable and appropriate, and on the instructions for use. If it is possible,

the CE marking shall be affixed on the packaging of the medical device, in which the

is sold.



(5) for the CE marking shall be accompanied identification number of the notified body,

who is responsible for compliance with the procedure, in accordance with the rules referred to in

Annexes 2, 4, 5 and 6 to this regulation.



(6) on the medical device, its packaging or the instructions accompanying the

medical device you can place another character, provided that it

is not reduced the visibility and legibility of the CE marking. On the medical

the resource cannot be to affix marks or inscriptions which are likely to mislead

third parties as to the meaning and form of the CE marking.



(7) medical device which is not provided with the CE marking, or

does not meet the requirements of this regulation or of the law on health care

resources can be exhibited at trade fairs, exhibitions,

demonstrations, and other similar events, provided that

a visible sign clearly indicates that this resource cannot be

on the market or put into service until brought into conformity with this

Regulation and the law on medical devices.



§ 7



Placing on the market and putting into service



(1) on the market or putting into service of a medical device may be listed,

If



and laid down with him) was the way its properties are conformity

essential requirements and the result of this assessment, it was found that

medical device corresponds to the requirements of this regulation and, where

properly installed, maintained and used in accordance with their intended

the purpose is to bear the "CE" marking, meets the other requirements referred to in § 3

paragraph. 1 to 3, and the manufacturer has issued a written statement about it (hereinafter referred to as

"Declaration of conformity"), and



(b)) were to him, accompanied by information on its use in the Czech language in the

accordance with this regulation.



(2) the medical device is intended for clinical investigations can be made available

persons carrying out clinical exam only, are subject to the conditions

provided for by the law on medical devices and annex 8 to

application of this regulation.



(3) Individually made medical device may be placed on

the market and/or put into service, if it have undergone conformity assessment in accordance with annex

# 8, and individually manufactured medical device was

accompanied by the statement referred to in that annex, which is available

to a particular patient.



(4) a medical device intended for clinical investigation and individually

made medical device with CE marking neopatřuje.



§ 8



Notified body



(1) the authorization of legal entities under the law on technical

requirements for products shall apply the requirements set out in annex No 10

to this regulation. Legal entities which meet the criteria laid down in

the relevant harmonized standards shall be considered as persons who satisfy

the relevant minimum criteria required to obtain credentials.



(2) the notified body and the manufacturer or his authorised representative to

pursuant to the agreement lays down the time limits for completion of the evaluation and validation

the activities referred to in annexes 2 to 6 of this regulation.



(3) If a notified body finds that the manufacturer has failed to fulfil the relevant

the requirements of this regulation or is longer, fulfilled, or if the certificate

not be published, notified, having regard to the principles of

adequacy, suspends, withdraws or restricts the use of the certificate, which

released, except in cases where the manufacturer ensure compliance with these

the requirements of the implementation of appropriate corrective measures. In the case of

suspension, withdrawal or any limitation on the certificate or in the

cases in which the intervention of the Authority may be needed for standards,

Metrology and testing (hereinafter referred to as "the authority"), notified body

inform the Office. The Office shall inform the other Member States

The European Union, Contracting States to the agreement on the European economic area,

Switzerland and Turkey (hereinafter referred to as "Member State") and the European Commission.



(4) the notified body shall inform the Office of any certificates issued, modified,

supplemented, suspended, withdrawn or refused and certificates

the notified body shall inform the other about suspended, withdrawn or

the refused certificates and, on request, about certificates issued.

Notified body shall make available, upon request, also any other relevant

information on issued certificates.



(5) the notified body shall provide to the Authority on request, all relevant

information and documents, including budgetary documents, to enable

verification of compliance with the criteria laid down in annex 10 to this regulation.



§ 9



Transitional provisions



(1) the medical device is placed on the market before the date of entry into force of

This regulation in accordance with the existing legislation, it is considered

medical device marketed in accordance with this regulation.



(2) Authorized and notified the person responsible for the activities in the

conformity assessment according to Decree-Law No 336/2004 Coll., as amended by

amended, shall be regarded as authorized and notified body

responsible for the activities of conformity assessment pursuant to this regulation.



§ 10



The effectiveness of the



This Regulation shall enter into force on 1 January 2000. April 2015.



Prime Minister:



Mgr. Sobotka in r.



Minister of health:



Mudr. Němeček, MBA, in r.



Annex 1



The basic requirements



(I).



General requirements



1. A medical device shall be designed and constructed so that, when

the use under the conditions and for the intended purpose does not undermine the clinical

condition or the safety of patients, or the safety and health of users,

where applicable, other persons, provided that any risks which

can with the intended purpose of a medical device to be related, are

acceptable in comparison with its benefit for the patient and the medical

resource corresponds to a high level of protection of health and safety. It

includes:



1.1. reduction, where possible, the risk of errors when using as a result

the ergonomic features of the medical device and the environment in

which can be a medical device being used and the



1.2. the assessment of the technical knowledge, experience, education and training

users, or even the health and physical condition of users for

that is a medical device designed.



2. the Solutions adopted by the manufacturer for the design and construction of the medical

resource must be in accordance with the principles of safety and with the current

the level of science and technology. When selecting the most appropriate solutions, the manufacturer

is based on the following principles in the following order:



2.1. eliminate or at least minimize all risks in a safe

the design and construction of the medical device,



2.2. to do so, where appropriate, the corresponding protective measures

including, if necessary, a warning against the hazards which cannot be

exclude,



2.3. inform the user about the persistence of risk as a result of failure to

the full perfection of the latest protective measures.



3. A medical device must achieve the performances intended

by the manufacturer and be designed, manufactured and packed in such a way that it was suitable for a


or more of the purposes of complying with the definition of a medical device in accordance with

the law on medical devices, and in accordance with the specifications

manufacturer.



4. when the load of the medical device, which can occur during normal

operating conditions must not be adversely affected by its

the characteristics and performances referred to in points 1, 2 and 3 of this annex to the

the extent that could endanger the health or safety of the patient

or user or other persons, for the lifetime of

indicated by the manufacturer of the medical device, if the manufacturer this time

It has specified.



5. A medical device shall be designed, manufactured and packed in such a way that

under the conditions laid down by the manufacturer for its storage and transport, as

in particular, temperature or humidity, could be adversely affected by the

its properties and performance.



6. each side effect of a medical device may pose

the only acceptable risk compared with the intended effects of the medical

resource.



7. demonstration of conformity with the essential requirements must include a clinical

reviews pursuant to the law on medical devices.



II.



Design and construction requirements



8.



Chemical, physical and biological properties



8.1. A medical device shall be designed and constructed so as to be

guarantee the characteristics and performances referred to in the General

requirements. Special attention should be paid to



8.1. 1. selection of materials intended for the manufacture and packaging of medical

resources, particularly in terms of toxicity and, where appropriate, flammability,



8.1. 2. mutual compatibility between the materials used and biological

tissues, cells and body fluids, taking account of the intended purpose, and



8.1. 3. results of the biofyzikálního or the model of research, whose

force has previously demonstrated.



8.2. A medical device shall be designed, manufactured and packed in such a way

to minimise the risk arising from the pollution side

substances and components of the radiation and their residues to users and persons

involved in the transport, storage and use of medical

resource in accordance with its intended purpose. Special attention should be

paid to the effect on the tissue, the time and the frequency of this action.



8.3. A medical device shall be designed, manufactured and packed in such a way

so that it can be safely used along with substances and gases with which the

comes into contact in normal use and practices.



8.4. In the case that the medical device is intended to administer medicinal products,

must be designed and constructed so that, when the specified purpose has been with these

medicinal products within the limits compatible provisions and limits governing this

medical device controls and to preserve its functional

capability in accordance with its intended purpose.



8.5. The provisions for medical devices with integrated medicine

or derivative of human blood



8.5. 1. If a medical device incorporates, as its

integral part, a substance, which can be used separately

considered to be a medicinal product and which is liable to act upon the body of complementary

effect to the effect of a medical device, must be quality, safety

and usefulness of that substance, verified by analogy using methods referred to in

the law on pharmaceuticals ^ 8).



8.5. 2. For the substances referred to in point 8. 5.1. of this annex, the notified

a person having verified the usefulness of the substance as part of the medical

device and taking account of the intended purpose of a medical device

requests the expert opinion on the quality and safety of the substance including

clinically certified risk-benefit ratio in the integration of the

a substance in a medical device from one of the competent authorities

the Member States or from the European Medicines Agency (hereinafter referred to

"the Agency"). If the expert opinion requested by the State Institute for

drug control (hereinafter referred to as "the Institute"), takes into account the manufacturing process and the

information about the usefulness of the inclusion of a substance in a medical device,

the notified body.



8.5. 3. If a medical device incorporates, as its

an integral part, a human blood derivative, the notified body

Having verified the usefulness of the human blood derivative as part of

the medical device and taking account of the intended purpose of the

the medical device expert opinion of the Agency on the quality and

the safety of this human blood derivative, including clinically certified

the risk-benefit ratio of the incorporation of the human blood derivative into the

the medical device.



8.5. 4. if carried out changes on additional substance incorporated into

a medical device, in particular as regards its manufacturing process,

must be informed about changes to the notified body, which requests the

expert opinion relevant competent authority that issued the original

expert opinion to confirm that the quality and safety of

additional substance is preserved. If the expert opinion required

Institute, takes into account the data related to the usefulness of incorporation of additional substances to

medical device, which notified body for the purpose of

ensure that the changes have no negative impact on clinically proven

the risk-benefit ratio in the inclusion of this additional substances to the

the medical device.



8.5. 5. If the Department, as appropriate, the competent authority which issued the

the original expert opinion, informed of additional substance that

could have an effect on a clinically proven risk-benefit ratio when

its inclusion in the medical device, the notified body shall communicate to the person

expert opinion, whether this information has an impact on the established clinically

certified risk-benefit ratio when the inclusion of additional substances to the

medical device or not. Notified body shall take account of

the updated scientific opinion when reviewing its conclusion from the

the conformity assessment procedure.



8.6. A medical device shall be designed and constructed so that the

the risks posed by substances leaking from the device

reduced to a minimum. Special attention should be paid to agents

carcinogenic, mutagenic or toxic for reproduction in accordance with the law on

chemical substances.



8.7. If part of a medical device or medical

the resource as a whole, which is intended for use by the manufacturer or

disposal of medicines, body fluids or other substances to the

the body or out of the body, or a medical device designed for transport and

storage of such body fluids or other substances containing phthalates

classified as carcinogenic, mutagenic or toxic for reproduction

category 1 or 2 in accordance with the Act on chemical substances, must be accompanied by

medical device directly identified as a medical device

that contains phthalates, or must be by each of its

a piece, or, where appropriate, its sales packaging. If the intended purpose of the

This medical resource includes treatment of children, pregnant women or

women who are breastfeeding, the manufacturer must submit, for the use of such substances in the framework of the

the technical documentation of the specific statement of reasons with respect to compliance with the

essential requirements and in the instructions for use to provide information about the

residual risks for these user groups, and if possible,

also on appropriate preventive measures.



8.8. A medical device shall be designed and constructed so that the

the risk of undesirable ingress into it, having regard to the medical

the resource and the nature of the environment in which it is to be used, has been reduced to

the lowest possible rate.



9.



Infection and microbial contamination



9.1. Medical device and its manufacturing processes must be designed

so, in order to eliminate or reduce as far as possible at the lowest possible level

the risk of transmission of infection to the patient, medical device user

and other persons or contamination of the medical device listed

persons.



9.2. Tissues of animal origin used in the manufacture of medical

the resource must come from animals which had been practiced veterinary

supervision to the extent corresponding to the intended purpose of these tissues. For information about the

the geographical origin of such animals shall keep the notified body.



9.3. Processing, preservation, testing and treatment of tissues, cells and

substances of animal origin must be carried out so as to achieve the

the optimum level of safety, in particular against viruses or other contamination

the originators of the infection in the manufacture of the medical device, and that the introduction of the

validated methods for the inactivation of viruses or virus removal

or other agents of infection.



9.4. Medical device is supplied in a sterile State must be

designed, manufactured and packaged in packaging for single use, or must

be the appropriate procedures to ensure that at launch, will be sterile and

under the conditions of storage and transportation will remain sterile until

will the protective packaging is opened or damaged.



9.5. Medical device is supplied in a sterile State must be

manufactured and sterilized by an approved accordingly.



9.6. Medical device which is intended to be sterilized must be

manufactured in appropriately controlled conditions.




9.7. Packaging systems for non-sterile aluminium of a medical device must

ensure the specified level of purity of the medical device.

If the medical device is to be sterilized prior to use,

packaging systems must reduce the risk of microbiological contamination

the lowest possible rate. Packaging systems must be suitable for use

sterilization methods specified by the manufacturer.



9.8. Identical or similar to medical devices that are

sold in a sterile condition, even in non-sterile must be mutually

differentiated packaging or labelling.



10.



Construction and properties in relation to the environment



10.1. In the case that it is a medical device designed to be used in the

conjunction with another medical device, or to the relevant equipment,

thus created must be set, including the connection system, safe and

must not interfere with established performance requirements of medical

resources. Any restrictions must be indicated in the labelling

medical device or in the instructions for use.



10.2. A medical device shall be designed and constructed so that the

deleted, or at the lowest possible level of reduced risk



10.2. 1. injuries resulting from the physical properties of the medical

device, including the volume and pressure ratio, dimensional, or even

ergonomic features,



10.2. 2. associated with predictable conditions of ambient zdůvodněně

environment, in particular magnetic fields, external electrical influences,

electrostatic discharge, pressure, temperature or variations in pressure and

acceleration,



10.2. 3. interaction with other medical devices

commonly used when a specific investigations or treatment,



10.2. 4. arising from ageing of materials used or loss of

the accuracy of the measuring or control mechanism as well as from the fact

the medical device cannot maintain or calibrate (implants).



10.3. A medical device shall be designed and constructed so that the

deleted or reduced to the lowest possible level of risk of fire or

explosion during normal use and in single fault occurs. Special

attention should be paid to the medical device, which is designed

for use in an environment of inflammable substances, or substances that can

cause burning.



11.



Measuring functions



11.1. Medical device with a measuring function must be designed and

constructed so as to provide sufficient accuracy and stability in the

accuracy limits with regard to its intended purpose. The limits of accuracy provides

manufacturer.



11.2. The scale of the measuring instruments and displays shall be dealt with in accordance with the

ergonomic principles with regard to the intended purpose.



11.3. The results of the measurements carried out in a medical device with a measuring

function must be expressed in legal units under the legislation

the provisions governing metrology ^ 9).



12.



Radiation protection



12.1. A medical device shall be designed and constructed so that the

exposure of patients, users and other persons to the effects of radiation, it was with

regard to the intended purpose of the reduced to the lowest possible level, without

was limited to use of the necessary levels of radiation for diagnostic and

therapeutic purposes.



12.2. If there is a medical device designed to emit radiation in the

dangerous levels, but necessary for a specific medical

the purpose of the benefit of which is considered appropriate for this risk, you must have

staff the ability to control the level of such emissions. Such

a medical device shall be designed and constructed so that the

guaranteed reproducibility and tolerance of relevant variables

parameters.



12.3. In the case that it is a medical device designed to emit

potentially dangerous radiation, must be, where possible, provided with a

Visual or audible alerts that notify you when these emissions.



12.4. A medical device shall be designed and constructed so that the

exposure of patients, users and other persons, accidental or

scattering unwanted radiation is limited to the lowest possible level.



12.5. Manual or operating instructions for use of the medical

emitting the radiation resource must contain detailed information about the

the nature of the emitted radiation, means of protecting the user, and about

ways to prevent misuse of this radiation and the risks of exclusion

from the installation of such a device.



12.6. Medical device intended to emit ionizing radiation

must be designed and constructed so that, where this is intended,

It was possible to change and control the quantity, geometry and quality of the emitted

radiation.



12.7. Medical device emitting ionizing radiation intended for

radiodiagnostiku must be designed and constructed so that the appropriate quality

to display or output for the intended medical purpose has been made in

the smallest possible radiation load of the patient and of the user, or a third

of the person.



12.8. Medical device emitting ionizing radiation intended for

radiotherapy must be designed and constructed so that it can be reliable

monitoring and control of the delivered dose, the type and energy of radiation, volume

where necessary, as well as the quality of the radiation.



13.



Electrical safety and electromagnetic compatibility



13.1. Medical device containing electronic programmable

systems must be designed to ensure the functional stability,

the reliability and performance of these systems according to the intended

the purpose of. On the occurrence of defects in this system must be appropriately

eliminated or reduced the subsequent risk to the lowest possible level.



13.2. In the case of a medical device, which contains the program

equipment, or that is in itself a medical softwares,

the software must be validated according to the latest findings with

taking into account the principles of development lifecycle, risk management, validation

and authentication.



13.3. Medical device for which depends on patient safety

internal energy sources, must be fitted with a device allowing to determine the

the status of energy sources.



13.4. Medical device for which depends on patient safety

external energy sources, must be equipped with a warning system to

signalling the failure of this resource.



13.5. Medical device intended to monitor one or more

clinical data of a patient must be equipped with the corresponding warning

systems that will report the emergence of a situation that could lead to death

to the patient or to a serious deterioration in his State of health.



14.



14.1. A medical device shall be designed and constructed so that the

at the lowest possible level of reduced risk of electromagnetic fields,

which could impair the operation of other medical devices or

devices in their usual environment.



14.2. A medical device shall be designed and constructed so that, under

provided the proper installation and use it if possible

eliminate the risk of accidental electric shocks during normal

use on the occurrence of any faults.



14.3. A medical device shall be designed and constructed so that the

guarantee the protection of the patient, user and third parties against risks

related to mechanical properties, in particular with the strength,

stability and movement of certain parts.



14.4. A medical device shall be designed and constructed so that the

It was, taking into account the current level of science and technology and the available

options to reduce vibration at their source, reduced to the lowest possible

the risk arising from vibration induced by medical

means, unless the vibrations are part of the specific specific

the purpose of the.



14.5. A medical device shall be designed and constructed so that the

It was, taking into account the current level of science and technology and the available

to reduce noise, particularly at source, reduced to the lowest

possible hazards arising from the noise emitted by it, if this

noise is not a specific part of the intended purpose.



15.



15.1. A medical device shall be designed and constructed so that the

reduced to the lowest possible level the risks arising from the end and

the connecting parts of this medical device resources

electrical energy, pressure of the fluid, air and gas, which must

the user or the staff to handle.



15.2. A medical device shall be designed and constructed so that its

accessible parts and their surroundings, with the exception of the parts or areas intended to

supply heat or reach given temperatures, reaching for

normal operating conditions potentially dangerous temperatures.



15.3. Medical device intended to supply energy or substances

the patient must be designed and constructed so that the delivery might

be regulated with precision that ensures the safety of the patient and

the user.



15.4. Medical device intended to supply energy or substances

the patient must be equipped with a device to indicate, where appropriate,

prevents the delivery of a disproportionate amount of energy or substances that could

could be dangerous. Medical device must be equipped with appropriate


the device, which is capable of to the extent possible to avoid accidentally

the release of dangerous quantities of energy or substance from its sources.



15.5. The medical device must be clearly stated feature

controls and indicators. If the medical device

located instructions needed for its operation or indicate operating or

setting parameters via the Visual system, these must be

information understandable to the user and, where appropriate, the patient.



Information provided by the manufacturer



16.



16.1. Each device must be accompanied by the information

necessary for its safe and proper use, taking into account the

training and knowledge of the potential users, where appropriate, the operator

personnel, and to identify the manufacturer. Such information comprises

the information on the label of a medical device and in the operating instructions.



16.2. Where practicable and appropriate, the information must be in accordance with section

16.1. This annex to the medical device, the

the packaging of each piece, or on the packaging in which it is sold.

If the unit is not practicable, the packaging information must be contained in the

operating instructions supplied with one or more medical devices.



16.3. The packaging of each medical device must be accompanied by

instructions for its use; This does not apply for medical device risk

class I or IIa if the instruction manual is not needed for its safe

the use of.



16.4. If it is appropriate to ensure that the information referred to in point 16. 1. have been in

the form of the symbols used must be a symbol (marker) or identification color

comply with the harmonised standards. In the areas for which the harmonised

standards exist, the symbols and colours must be described in the documentation

supplied with a medical device.



17.



17.1. Marking medical device contains



17.1. 1. the name or business name and address of the registered office, if the

the manufacturer of a legal person; name or business name and registered office

where appropriate, the address of its principal business establishment, where appropriate, the address of the

residence, if the producer is a natural person; for medical devices

imported into the Member States of the European Union with a view to their

distribution within the European Union, the label, or the outer packaging, or instructions for

use also contain the name or business name and address

the place of business of the manufacturer's authorised representative, if

does not have a registered office in a Member State,



17.1. 2. detailed information that the user needs to

identification of the medical device and the content of the packaging,



17.1. 3. the inscription "STERILE" ("sterile"), in the case of sterile medical

resource,



17.1. 4. If necessary, the manufacturing batch number (hereinafter referred to as "the lot"),

preceded by the word ' LOT ', or the serial number,



17.1. 5. If necessary, specify the date by which it can be medical

device should be used, expressed as the year and month



17.1. 6. indicate that this is a medical device for the

single use, with information about the manufacturer, that it is a

single-use medical device, must be within the

The European Union stands United,



17.1. 7. the inscription "Individually made medical device"

in the case of individually prepared medical device



17.1. 8. the inscription "Only for clinical trials", if the medical

the device is intended for this purpose,



17.1. 9. special conditions for storage or handling,



17.1. 10. special operating instructions,



17.1. 11. the alerts, or other necessary measures,



17.1. 12. year of production, in the case of any active medical device, if the

It does not indicate the expiry date; This information may be included in

lot numbers or serial numbers, if these data easily

an inheritable,



17.1. 13. the method of sterilization of the device, if it comes

into account, and



17.1. 14. indicate that the device contains a derivative of

human blood, if it comes to such a medical device.



17.2. If you can reasonably assume that the intended purpose of medical

the resource may not be obvious to the user, the manufacturer shall indicate in the labelling

the medical device and the instructions for its use.



17.3. If it is appropriate and feasible, it must be medical

resource and its removable components, in particular data on

production lot or batch, when the specified purpose of use would be

determine the risks posed by the medical device and its

components.



17.4. Instructions for use, if this is not the nature of the medical device

out of the question, it must contain



17.4. 1. the particulars referred to in paragraph 17. 1 of this annex, with the exception of

paragraph 17.1.4. and 17. 1.5,



17.4. 2. information on the performance of a medical device in accordance with

point 3 of this annex, as well as about side effects



17.4. 3. detailed information on the characteristics of the medical device to

It was possible to determine the appropriate medical devices or equipment, the

using a secure system or a combination of, in the case of medical

resources, which, according to the intended purpose of use must be installed

or connected to other medical devices or equipment



17.4. 4. the information needed to verify whether the medical device

properly installed and can be operated correctly and safely, including

the necessary data on the nature and frequency of the maintenance and calibration

necessary to properly and safely,



17.4. 5. information about how to avert the dangers associated with

the implantation of a medical device if necessary,



17.4. 6. information regarding the risks of reciprocal influence between the

medical devices present during specific investigations or

treatment,



17.4. 7. the necessary instructions in the event of damage to the sterile packaging,

where appropriate, information on the appropriate processes in the re-sterilization,



17.4. 8. information on the appropriate processes to allow for repeated

the use of the medical device, including cleaning, disinfection,

packaging, or on the appropriate processes re-sterilisation

medical device, and recommend the number of repeated use,

If the medical device is intended for repeated use;

If the medical device is supplied with it, it has to be before

the use of sterilised must be instructions for cleaning and sterilization of such

compliance with the medical device permanently suit

General requirements; If the medical device is identified as

single-use medical device, must contain

information on known characteristics and technical factors medical

resource that producers are aware of and which could, with repeated

the use of the medical device constitute a risk; If may not be

instructions for use, this information must be available to the user on the

upon request,



17.4. 9. data on the treatment of a medical device prior to its

to use it, especially about the sterilization, final report

medical devices,



17.4. 10. data on the nature, type, intensity and distribution of the issuing

radiation for medical device emitting radiation for medical

purposes, and



17.4. 11. date of issue or the date of the last revision of the instructions for use.



17.5. Instructions for use, if this is not the nature of the medical device

excluded, must also include details that will allow

health-care professionals refer the patient on any contra-indications and

necessary preventive measures. These figures fall



17.5. 1. the measures to be taken in the event of changes in functional

the competence of the medical device,



17.5. 2. the measures to be taken under the foreseeable conditions

respect the environment, in particular with regard to the effects of the magnetic

fields, external electrical influences, electrostatic discharge, pressure or

changes in pressure, acceleration, thermal ignition sources,



17.5. 3. adequate information regarding the medicinal product or products

substances that are applied through the medical device,

including limitations in the choice of substances to be administered,



17.5. 4. the measures necessary for the safe removal of the medical

resource, in particular in case of unusual risks related with this

activities,



17.5. 5. information on medicinal substances, or human blood derivatives

contained in a medical device as an integral part of the

accordance with point 8. 5 of this annex, and



17.5. 6. information on the degree of precision required for medical

a resource with a measuring function.



Annex 2



EC declaration of conformity



The full quality assurance system



1. The manufacturer ensures the implementation and operation of the quality system approved

for the design, manufacture and final inspection of the medical device according to the

section 6 of this annex.



2. The quality system shall be subject to audit in accordance with point 7 of this annex, and shall be subject to

surveillance as specified in point 11 of this annex.



3. full quality assurance System is the procedure whereby the manufacturer who

procedure referred to in point 1 of this annex ensures and declares that the


the medical device conforms to the provisions of this regulation,

which apply to it.



4. the manufacturer affixes the CE marking medical device in accordance with §

6, draws up and maintains a written declaration of conformity.



5. Declaration of conformity applies to one or more produced

clearly marked medical devices called medical

resource, the product code of the medical device or other

a unique reference.



6.



The quality system



6.1. The manufacturer shall submit a written request to the notified person assessment

(evaluation and approval) of its quality system.



6.2. The request contains



6.2. 1. the name or business name, address of the registered office or the address of the

the main race, where appropriate, place of residence, if the producer is a natural

the person; the name or business name and address of the registered office, in the case of legal

person; in both cases, including the addresses of manufacturing sites, in which the system

the quality of the subject,



6.2. 2. all information on the medical device or category

medical devices, which are covered by the quality system,



6.2. 3. a written declaration that the notified body on the other has not been submitted

the request for the same quality system related to the same

medical device,



6.2. 4. the quality system documentation,



6.2. 5. an undertaking to proceed in accordance with the approved system

the quality,



6.2. 6. an undertaking to maintain the quality system in a usable and

efficacious, and



6.2. 7. an undertaking shall implement and update systematic

procedure to review experience gained from medical devices

placed on the market, including the clinical trial in accordance with the law on

medical devices, and in an appropriate manner to implement the necessary

corrective measures; part of this commitment, the manufacturer is notified to the Institute

adverse events according to the law on medical devices

without delay, but not later than within 15 days from the date of the finding.



6.3. The application of the quality system ensures that medical device

corresponds to the provisions of this regulation, and that at each stage of its

design to final inspection.



6.4. The elements, requirements, and measures taken by the manufacturer for it

applicable quality system must be documented in a systematic and

in the form of writing developed by the programs and procedures which are programs

quality, quality plans, quality manuals and quality records. It

includes the corresponding documentation, data and records arising from the

the procedures referred to in point 6. 5.3 of this annex.



6.5. The quality system documentation shall contain in particular an adequate description of



6.5. 1. the objectives of the quality specified by the manufacturer,



6.5. 2. the Organization of the establishment, in particular



6.5. 2.1. organisational structures, the responsibilities of executive employees

and their powers in relation to the quality of design and manufacture

medical device,



6.5. 2.2. the methods of monitoring the effectiveness of the quality system, in particular its

the ability to achieve the desired quality of design and produced

the medical device, including the inspection of the medical device, u

which has not been reached,



6.5. 2.3. where the design, manufacture and/or final inspection of the medical

the device or its parts is performed by a third party, the methods of monitoring the

the efficient operation of the quality system and in particular the manner and extent of checks

carried out by over a third party,



6.5. 3. the procedures for monitoring and verifying the design of the medical

the device, including adequate documentation, in particular



6.5. 3. the 1. a general description of the medical device, including all

variants planned, and its intended use,



6.5. 3.2. the design specifications, including the harmonised standards which are

apply the results of the risk analysis and a description of the solutions adopted to meet the

the essential requirements applicable to the medical device, if the

the harmonised standards are not applied in full,



6.5. 3.3. techniques used to control and verify the design, procedures

and systematic measures that will be used when designing the

medical device,



6.5. 3.4. If the medical device is connected to another

medical device or medical devices for the purpose of

intended, proof must be provided that it conforms to the basic

requirements when connected to any such medical device or

medical devices that have the characteristics specified by the manufacturer,



6.5. 3. the 5. a statement of whether a medical device contains as its

integral part, a substance or human blood derivative referred to in section 8.

5. Annex 1 to this regulation, and the data on the tests conducted in

this connection required to assess the safety, quality and

the usefulness of that substance or human blood derivative, taking account of the

the intended purpose of a medical device,



6.5. 3.6. a statement indicating whether it is a medical device made with

the use of tissues of animal origin referred to in Commission Regulation No 722/2012

specific requirements relating to the requirements set out in

Council directives 90/385/EEC and 93/42/EEC with respect to the active

implantable medical devices and medical devices

manufactured utilising tissues of animal origin



6.5. 3.7. the solutions adopted as referred to in part I, point 2 of Annex No.

1 to this regulation,



6.5. 3.8. the pre-clinical evaluation,



6.5. 3.9. clinical trial under the law on health care

resources,



6.5. 3.10. a proposal for labelling or instructions for use,



6.5. 4. methods of examination and quality assurance in the stage production

a medical device, in particular



6.5. 4. the 1. the methods and procedures which will be used primarily for

sterilization and the purchase and other relevant documents,



6.5. 4.2. How to identify medical device

drawn up and updated in all stages of production on the basis of

drawings, specifications or other relevant documents, and



6.5. 5. the tests and trials which will be carried out before,

during and after manufacture of the medical device, their frequency and

used test equipment; must be able to adequately backward

the calibration of the test equipment.



7.



Audit



7.1. Notified body must audit the quality system in order to

determine whether a quality system satisfies the requirements set out in section 6 of this

of the annex. Compliance with these requirements for quality systems

that use the corresponding harmonised standards.



7.2. In a team responsible for assessment of the quality system must be at least

one Member, who has experience in assessing technology

the medical device. Part of the assessment is the assessment of the dossier

the design of the relevant medical device on a representative

the basis of an inspection tour of the manufacturing processes in the cutting rooms

and manufacturer in justified cases and review of the production processes in the

the suppliers premises or other contractual partners

manufacturer.



7.3. Notified body shall notify the manufacturer, after completion of the audit

the decision, which must contain the conclusions of the inspection and the reasoned

assessment decision.



7.4. The manufacturer shall inform the person who approved the certification system

quality of plan for substantial changes to the quality system or covered with

range of medical devices. Notified body shall evaluate the proposed

changes, verify whether after these changes the quality system still complies with the

the requirements referred to in point 6 of this annex, and its decision, which must

contain the conclusions of the inspection and a reasoned assessment, it shall notify the manufacturer.



8.



Examination of the design



8.1. The manufacturer so requests, in addition to its tasks under paragraph 6 of this annex,

by the person for examination of the design dossier relating to the

a medical device that has the manufacturer intends to produce, and that

It is listed in points 6. 1. and 6. 2 of this annex.



8.2. The application contains a description of the design and manufacture of the medical device,

that has the manufacturer intends to produce, including details of its functional

eligibility. The application also contains information that will allow to assess whether

medical device complies with the requirements referred to in point 6. 5.3 of this

of the annex.



8.3. Notified body shall examine the application, and if a medical

the resource meets the requirements of this regulation, shall issue a certificate to the applicant

EC design examination. Notified body may ask for tweens

request other tests or evidence to enable it to assess the conformity of the

the medical device with the requirements of this regulation. The EC certificate of

design review must contain the conclusions of the examination, the conditions of

its validity, the data needed for identification of the approved design

medical device, where applicable, a description of its intended purpose.



9.



The drug or human blood derivative, as an integral part of the



9.1. In the case of a medical device referred to in point 8. 5.1.

Annex 1 to this regulation, shall request the notified body before the adoption of

the decision of the expert opinion by one of the competent authorities designated

the Member States, the Czech Republic, the Institute, or the Agency. If it is about

expert opinion requested by the Institute, the scientific opinion shall draw up to 210

days from the date of receipt of the complete documentation. The professional opinion of the competent


authority of the Member State or the Agency must be included in the documentation

relating to the medical device. Notified body for the adoption

the decision devotes due attention to this opinion and its

the final decision shall notify the institution that this expert opinion

has released.



9.2. In the case of a medical device referred to in point 8. 5.2.

Annex 1 to this regulation must be professional opinion of the Agency

included in the documentation concerning the device.

Notified body when adopting decision devoted to the opinion

The Agency, due attention. Notified body shall not issue a

the certificate if the Agency's scientific opinion is unfavourable.

Notified body shall inform the Agency of its final decision.



10.



Changes



10.1. Changes to the approved design that may affect the conformity with the

the essential requirements of this regulation or the conditions prescribed for the

the use of a medical device must receive further approval

certification that issued the EC design examination certificate.

The applicant shall inform by the person who issued the certificate the EC

examination of the design of all modifications to the approved design.



10.2. The additional approval of the proposal referred to in point 10. 1. this annex shall issue

notified body as a supplement to the EC design examination certificate.



11.



Supervision



11.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



11.2. The manufacturer authorizes the person to perform the necessary by the notified body

checks and provides it with the relevant information, in particular



11.2. 1. the quality system documentation,



11.2. 2. the data stipulated in the part of the quality system relating to design,

such as results of analyses, calculations, tests, the solutions adopted in part

I. section 2 of annex 1 to this regulation, pre-clinical and clinical

reviews, plan subsequent clinical tracking after placing on the market and

where appropriate, the results of subsequent clinical tracking after placing on the market, and



11.2. 3. data defined quality system for the production area

medical devices, in particular, inspection reports, test results,

data, calibration data, and reports on the qualifications of the staff concerned, etc.



11.3. Notified body performs



11.3. 1. appropriate examinations and assessment on a regular basis so as to

make sure that the manufacturer applies the approved quality system, and provides

the producers of the evaluation report, and



11.3. 2. unannounced inspection, which is entitled, in the case of

of necessity, carry out or ask for tests in order to

check that the quality system is effective, and properly carried out the inspection,

where appropriate, of the outcome of the test, if carried out, provides

manufacturers report.



12.



Retention of documents



The manufacturer of the medical device or his authorised representative

kept for at least 5 years from the date of manufacture of the medical

a resource at the disposal of the competent authorities



12.1. a declaration of conformity,



12.2. documentation of the quality system in accordance with section 6. 2. the 4. of this annex, and

in particular the documentation, data and records arising from the procedures

referred to in point 6. 5.3. of this annex,



12.3. documentation of changes in accordance with point 7. 4. of this annex,



12.4. the documentation referred to in point 8. 2. of this annex,



12.5. certificates and other documents issued by a person referred to

in points 7. 3., 8. 3., 10. 2. (a) 11. 3. of this annex.



13.



The application procedures for medical device risk class IIa or

IIB



13.1. In accordance with article 4, paragraph 2. 2 and 3 may be the procedures set out in this

Annex applied for medical device risk class IIa and

IIB. Provisions on the examination of the design of a medical device in accordance with

points 8 and 10 of this annex shall not apply in this case.



13.2. In the case of a medical device risk class IIa shall examine the

notified body as part of the assessment referred to in point 7 of this annex

the technical documentation of at least one representative sample from each

a subgroup of medical devices, as specified in point 6. 5.3. with a view to

to assess compliance with the provisions of this regulation.



13.3. In the case of a medical device risk class IIb shall examine the

notified body as part of the assessment referred to in point 7 of this annex

the technical documentation of at least one representative sample from each

a group of generic medical devices, as specified in point 6. 5.3. This

the annexes, in order to assess compliance with the provisions of this regulation.



13.4. In choosing representative sample (s) notes

notified body into account the novelty of the technology, similarities in design,

technology, manufacturing and sterilisation methods, the intended use and the results of the

of any previous relevant assessments, in particular as regards the

physical, chemical or biological properties. Notified body

shall be documented and retained for the disposal of the competent administrative authorities of the reasons

the selection of a representative sample or samples.



13.5. Further samples shall be assessed as part of the supervision of the notified body

According to section 11 of this annex.



14.



Batch release



After completing the manufacture of each batch of a medical device, which

contains, as an integral part, a substance, which can be

used alone, considered to be a medicinal product constituent or a medicinal product

product derived from human blood or human plasma, in the case that

its action is only an additional effect to the effect

medical device, the manufacturer shall inform the person of the certification

batch release of these medical devices and shall forward to it the certificate

concerning the release of the batch of human blood derivative used in this

medical device, issued by the competent laboratories designated for this

the purpose by the Member State, in the Czech Republic in accordance with the law on

pharmaceuticals.



Annex 3



EC type-examination



1.



Medical device type-examination is the procedure whereby the

notified body finds that a representative sample of assessed

manufacture of the medical device (hereafter named the type) satisfies the relevant

the provisions of this regulation that apply to it. In connection with the

the manufacturer ensures and declares that the medical devices supplied

on the market correspond to the certified type.



2.



Procedure the manufacturer



2.1. The manufacturer, or authorised representative so requests by

a person of the type-examination of the medical device.



2.2. The request contains



2.2. 1. the name or business name and the address or registered office address

the main business establishment, where appropriate, place of residence, if the manufacturer

is a natural person; the name or business name and address of the registered office, in the case of

the legal entity,



2.2. 2. the name and address of the authorised representative if the

a natural person; business name or the name and address of the registered office, in the case of

legal person



2.2. 3. the documentation referred to in point 2. 3. of this annex, which is

needed to assess the conformity with the requirements of this regulation; the applicant

pass the type of the notified person may request further samples, and



2.2. 4. a written declaration that the same application has not been lodged other

the notified person.



2.3. The documentation must be processed so as to enable an understanding of the

the design, manufacture and performances of the medical device and must

contain



2.3. 1. General description of the type, including any variants planned, and its

intended use,



2.3. 2. design drawings, manufacturing technology estimated,

in particular as regards sterilization, and diagrams of components, sub-assemblies and

circuits,



2.3. 3. the descriptions and explanations necessary for the understanding of the drawings and schemes

the functioning of the medical device,



2.3. 4. a list of the harmonised standards which have been fully or partially

used and a description of the solutions adopted to meet the essential requirements,

where the harmonised standards are not applied in full,



2.3. 5. results of the design calculations, risk analysis,

research, technical tests,



2.3. 6. a statement that the medical device contains as its

integral part, a substance or human blood derivative referred to in section 8.

5. Annex 1 to this regulation, and the data on the tests conducted in

this connection required to assess the safety, quality and

the usefulness of that substance or human blood derivative, taking account of the

the intended purpose of a medical device,



2.3. 7. a statement that the medical device is manufactured using

tissues of animal origin referred to in Commission Regulation on special requirements

related to the requirements laid down in Council directives 90/385/EEC and

93/42/EEC with respect to active implantable medical devices and

medical devices manufactured utilising tissues of animal origin



2.3. 8. the solutions adopted according to part I, point 2 of annex 1 to this

Regulation,



2.3. 9. the pre-clinical evaluation,



2.3. 10. a clinical trial according to the law on medical devices

and



2.3. 11. the proposal for the designation, where appropriate, instructions for use.



3.



How to obtain



3. the 1. Notified body shall examine and assess the documentation and verify that the

the type has been manufactured in accordance with that documentation. Notified body

captures all the components that are designed in accordance with


relevant harmonised standards, as well as those which, according to

the following harmonised standards are designed.



3.2. Notified body shall carry out or have carried out inspections and tests

necessary to verify whether the solutions adopted by the manufacturer meet the essential

the requirements under this regulation, where the harmonised standards are not

used. If the intended purpose is to be a health

resource associated with another medical device, or other

medical devices, it must be demonstrated that, in connection with such

a medical device or medical devices with

the characteristics specified by the manufacturer, the system, or a combination

as all the basic requirements.



3.3. Notified body shall carry out or have carried out appropriate checks

or the tests necessary to verify whether the manufacturer has chosen to apply the

harmonised standards, these have actually been applied.



3.4. Notified body agree with the applicant the location where the necessary

the examinations and tests carried out.



4.



The conditions for release of documents certification



4. the 1. If the type satisfies the provisions of this regulation, the

notified body EC type-examination certificate to the applicant. To

type-examination certificate shall be accompanied by the corresponding part of

documentation, the notified body shall keep a copy of the 1.



4.2. EC type-examination certificate contains



4.2. 1. the name or business name and the address or registered office address

the main business establishment, where appropriate, place of residence, if the manufacturer

is a natural person; the name or business name and address of the registered office, in the case of

the legal entity,



4.2. 2. the conclusions of the examination, conditions for its validity and the data

necessary to identify the approved type.



4.3. In the case of a medical device referred to in point 8. 5.2.

Annex 1 to this regulation, shall request the notified body before the adoption of

the decision of the expert opinion by one of the competent authorities designated

the Member States, the Czech Republic, the Institute, or the Agency. If it is about

expert opinion requested by the Institute, the scientific opinion shall draw up to 210

days from the date of receipt of the complete documentation. The professional opinion of the institution or

The Agency must be included in the documentation concerning the medical

resource. Notified body when adopting decision devoted to this

the opinion of the appropriate attention and its final decision to

body of this expert opinion.



4.4. In the case of a medical device referred to in point 8. 5.3.

Annex 1 to this regulation must be professional opinion of the Agency

included in the documentation concerning the device.

Notified body when adopting decision devoted to the opinion

The Agency, due attention. Notified body shall not issue a

the certificate if the Agency's scientific opinion is unfavourable.

Notified body shall inform the Agency of its final decision.



5.



Changes



5.1. The manufacturer, or the authorised representative shall inform the certification body

the person who issued the EC type-examination certificate of any

significant change made to the approved medical device.



5.2. Changes to the approved product must receive further

approval of certification that issued the EC type-examination certificate

where such changes may affect the conformity with the essential requirements

or with the conditions prescribed for use of the medical device.

Additional approval has the form of a supplement to the initial EC certificate

type-examination.



6.



The transmission and retention of documents



6.1. Other notified the person may obtain a copy of the certificate

type-examination, where applicable, their additions. Annex the following certificates

must be available to the other notified parties on the basis of a reasoned

request the prior informing the manufacturer.



6.2. The manufacturer or his authorized representative shall keep with the

the technical documentation copies of type-examination certificates and their

additions for a period of at least 5 years from the date of manufacture of the medical

resource.



Annex 4



EC verification



1.



Verification is the procedure whereby the manufacturer or his authorised representative

ensures and declares that the medical device which was

tested by the person corresponds to the type described in the certificate

the type-examination and satisfies the requirements of this regulation, the

apply.



2.



Procedure the manufacturer



2.1. Manufacturer shall carry out the necessary measures to ensure that the manufacturing

process produces medical devices corresponding to the type referred to in

type-examination certificate and satisfies the requirements of this regulation,

which apply to it.



2.2. The manufacturer prepares the documentation before you start the production

characterizing the



2.2. 1. the manufacturing process, in particular as regards sterilization, if it is

It must,



2.2. 2. the routine, pre-established provisions to be

introduced to ensure the homogeneity of the production, and



2.2. 3. where appropriate, the conformity of the medical device with the type

as described in the type-examination certificate and with the requirements that apply to

subject to this regulation.



2.3. The manufacturer or his authorised representative shall affix the CE marking and

draw up a written declaration of conformity.



2. the 4. The manufacturer ensures and maintains sterility in the manufacture of medical

resource placed on the market in a sterile State, for this purpose, proceed

In addition to the above, and pursuant to sections 2 to 4 of annex 5 to this

of the regulation.



2.5. The manufacturer shall undertake to Institute and keep updated a systematic

procedure to review experience gained from medical devices

placed on the market, including the clinical trial in accordance with the law on

medical devices. Part of this commitment, the manufacturer is

to report adverse events to the Institute, and it promptly, but not later than

15 days from the date of their findings and further and appropriate way to implement

the necessary corrective measures.



3.



How to obtain



3. the 1. Notified body performs the corresponding appropriate examinations and

tests in order to check the conformity of the medical device with the requirements of

This regulation in accordance with the decision of the manufacturer



3. the 1. 1. by checking and testing of each medical device according to the

point 4 of this annex, or



3. the 1. 2. by checking and testing of medical devices on the basis of

statistical methods as specified in point 5 of this annex.



3.2. Such checks shall not apply to components of the production process,

that apply to ensure sterility.



4.



Verification by examination and testing of each piece



4. the 1. Notified testing of every medical device

individually, in order to verify the conformity of each medical device

with the type described in the type-examination certificate and with the requirements of this

the regulation, which is applicable to it. Notified body performs

the appropriate tests as set out in the relevant harmonised standard, and in

If necessary, performs the equivalent of the test.



4.2. Notified body shall affix or cause to be placed on each approved

medical device your identification number and with reference to the

tests carried out shall draw up a written certificate of conformity of each

the medical device with the type-examination certificate as referred to in

type, and with the requirements stemming from this regulation.



5.



Statistical verification



5.1. The manufacturer shall submit to the medical devices manufactured in homogeneous

the batches.



5.2. Notified body removes from each batch of a randomly selected sample,

individual medical devices from this sample examines individually,

with the procedure referred to in point 4 of this annex, or individual

medical devices shall be subjected to an equivalent tests to assess the

the conformity of medical devices with the type as described in the certificate of

type-examination and with the requirements of this regulation, the

apply, for the purpose of determining whether the batch is to be approved, or

disapproved.



5.3. Statistical verification juxtaposition, or medical devices

the measurement uses sampling plans with the operational characteristics of which

ensure a high level of safety and performance according to the

the latest knowledge of science and technology. Sampling plans are set out

accordance with harmonised standards, taking into account the nature of the groups

medical devices.



5.4. If the notified body shall approve the batch, place or leave

place it on any medical device your identification number and

shall draw up a written certificate of conformity with reference to the tests carried out.

All medical devices in the batch may be placed on the market with

the exception of medical devices in the selected sample that were

found to be unsatisfactory.



5.5. If the notified body the lot does not approve, shall take measures to

avoid putting such a lot on the market.



5.6. Notified body may suspend the statistical verification, the

case of frequent failure to approve batches.



5.7. The manufacturer may place the device identification

the number of the notified body to its liability in the course of the

process.



6.



Retention of documents



The manufacturer of the medical device or his authorised representative


kept for at least 5 years from the date of manufacture of the medical

resource for the disposal of the competent administrative authorities



6.1. Declaration of conformity,



6.2. the documentation referred to in point 2 of this annex,



6.3. the certificates referred to in points 4. 2. and 5. 4. of this annex,

where appropriate, the



6.4. EC type-examination certificate referred to in annex 3 to this

of the regulation.



7.



The application procedures for medical device risk class IIa



In accordance with article 4, paragraph 2. 2 may be the procedures set out in this annex

applied in medical device risk class IIa with the fact that

by way of derogation



7.1. from points 1 and 2. 1. up to 2. 4. this annex on the basis of

Declaration of conformity the manufacturer ensures and declares that the medical

resource risk class IIa is made in accordance with the technical

documentation referred to in point 2 of annex 7 to this regulation and meets the

the requirements of this regulation, which is applicable to it, and



7.2. from points 1, 2. 1. up to 2. 4., and points 4 and 5 of this annex,

verification carried out by the person intended to confirm the conformity of the

medical device risk class IIa with the technical documentation

referred to in point 2 of annex 7 to this regulation.



8.



Batch release



In case of verification referred to in point 4 of this annex, upon completion of the production

each lot of a medical device that has as its

integral part, a substance, which can be used separately

considered to be a medicinal product constituent or a medicinal product

derived from human blood or human plasma, in the case that its

the action represents the only additional effect to the effect of the medical

resource, and in the case of verification referred to in point 5 of this annex, the manufacturer

by the notified body shall inform the person about the release of this batch of medical

resource and shall forward to it the official certificate concerning the release of the batch

human blood derivative used in the device issued by a

appropriate laboratory designated for this purpose by the Member State, in the United

Republic, in accordance with the law on pharmaceuticals.



Annex 5



EC declaration of conformity



Production-quality assurance



1.



1.1. The manufacturer ensures the implementation and operation of the quality system

approved for the manufacture and final inspection of the relevant medical

the means referred to in point 2 of this annex. The quality system shall be subject to audit

referred to in point 3 and to the surveillance as specified in point 4 of this annex.



1.2. The production quality is part of the security procedure by which the manufacturer,

acting in accordance with point 1. 1. ensures and declares that the

medical device corresponds to the type described in the certificate of

type-examination and splňujě requirements of this regulation, the

apply.



1.3. The manufacturer affixes the CE marking medical device in accordance with the

§ 6, draws up and maintains a written declaration of conformity.



1.4. The Declaration of conformity shall be drawn up for one or more produced

clearly marked medical devices called medical

the resource code, medical device or other unique

by reference.



2.



The quality system



2.1. The manufacturer shall submit a written request to the notified person about his

the quality system.



2.2. The request contains



2.2. 1. the name or business name and address of the registered office or the address of the

the main business establishment, where appropriate, place of residence, if the manufacturer

is a natural person; the name or business name and address of the registered office, in the case of

the legal person; in both cases, including the addresses of manufacturing sites

which are covered by the quality system,



2.2. 2. all relevant information on the medical device or the

the category of medical devices, on which the quality system applies,



2.2. 3. a written declaration that the notified body on the other has not been submitted

the request for the same quality system related to the same

medical device,



2.2. 4. the quality system documentation,



2.2. 5. an undertaking to proceed in accordance with the approved system

the quality,



2.2. 6. an undertaking to maintain the quality system in a usable and

efficacious,



2.2. 7. where appropriate, the technical documentation of the approved type

medical device and a copy of the type-examination certificate and



2.2. 8. an undertaking shall implement and update systematic

procedure to review experience gained from medical devices

placed on the market, including the clinical trial in accordance with the law on

medical devices; part of this commitment, the manufacturer is

to report adverse events to the Institute, and it promptly, but not later than

15 days from the date of their findings and further and appropriate way to implement

the necessary corrective measures.



2.3. The application of the quality system ensures that medical device

corresponds to the type described in the type examination certificate.



2. the 4. Requirements and measures used by the manufacturer for the system

quality must be systematically and duly documented in writing

established policies and practices. This quality system documentation

must allow the uniform interpretation of the concept of quality of medical devices

and procedures, in particular the quality programmes, plans, manuals and quality

quality records.



2.5. The quality system documentation contains a description of



2.5. 1. the objectives of the quality specified by the manufacturer,



2.5. 2. the Organization of the establishment, especially



2.5. 2.1. organisational structures, the responsibilities of executive employees

and their powers in relation to the manufacture of medical devices,



2.5. 2.2. the methods of monitoring the efficient operation of the quality system and in particular

its ability to achieve the desired quality of the medical device,

including control of medical devices that the required quality

below,



2.5. 2.3. the methods of monitoring the efficient operation of the quality system, and

in particular, the manner and extent of the checks carried out by over a third party, if

a third person conducts production or final inspection and testing

medical devices or their parts,



2.5. 3. techniques of checks and quality assurance of medical devices

in the stage of their production, in particular



2.5. 3. the 1. procedures that will be used, particularly as regards the

sterilization, the sale and the relevant documents,



2.5. 3.2. procedures for the identification of medical devices

developed and updated to all stages of production on the basis of drawings,

specifications and other relevant documents, and



2.5. 4. the appropriate tests and trials which will be carried out before,

during and after the production of medical devices, their frequency and

used test equipment; must be able to adequately backward

the calibration of the test equipment.



3.



Audit



3. the 1. Notified body must audit the quality system in order to

determine whether a quality system satisfies the requirements set out in paragraph 2. 3.

of this annex. Compliance with these requirements shall be presumed for systems

quality, for which the corresponding harmonised standards are used.



3.2. In a team responsible for assessment of the quality system must be at least

one member with experience of assessing the relevant technologies.

Evaluation procedure includes a tour of the premises of the manufacturer, and in

duly substantiated cases, control of the production processes in the operating

areas, or its suppliers, the manufacturer of the other Contracting Parties.



3.3. Notified body shall notify the manufacturer, after completion of the audit system

quality, its result, which must contain the conclusions of the inspection and

a reasoned assessment.



3.4. The manufacturer shall inform the person who approved the certification system

quality of plan for substantial changes to the quality system or covered with

range of medical devices. Notified body shall evaluate the proposed

changes, verify whether after these changes the quality system still complies with the

the requirements referred to in point 2. 3. of this annex and its decision, which

must contain the conclusions of the inspection and a reasoned assessment, it shall notify the manufacturer.



4.



Supervision



4. the 1. The aim of surveillance is to ensure that the manufacturer duly fulfils the requirements

arising out of the approved quality system.



4.2. The manufacturer authorizes the person to perform the necessary by the notified body

checks and provides it with the relevant information, in particular



4.2. 1. the quality system documentation,



4.2. 2. the technical documentation,



4.2. 3. data defined quality system for the production area

medical devices, especially the inspection report, the results of

and test data, calibration data, and reports on the qualifications of the relevant

employees.



4.3. Notified body performs



4.3. 1. appropriate examinations and assessment periodically, so that the

make sure that the manufacturer applies the approved quality system, and provides a

inspection and assessment report



4.3. 2. at its discretion, well in advance of unannounced checks

in which, if necessary, carry out or have carried out tests for

to check that the quality system is effective, and properly made

control and of the outcome of the test, if carried out, provides

manufacturers of a written report.



5.



Retention of documents



The manufacturer of the medical device or his authorised representative

at the disposal of the competent administrative authorities for a period of at least 5 years

from the date of manufacture of the medical device



5.1. Declaration of conformity,




5.2. the quality system documentation,



5.3. changes in accordance with point 3. 4. of this annex,



5.4. the technical documentation of the approved type and a copy of the certificate of

type-examination,



5.5. the decisions and reports of the notified body referred to in points 3. 4. and 4. 3.

of this annex,



5.6. where appropriate, EC type-examination certificate referred to in annex 3 to the

application of this regulation.



6.



The application procedures for medical device risk class IIa



6.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this

Annex applied for medical device risk class IIa with

by way of derogation from points 1. 2. up to 1. 4. in paragraph 2 of this annex for the

the basis of the Declaration of conformity the manufacturer ensures and declares that the

medical device risk class IIa are manufactured in accordance with

the technical documentation referred to in point 2 of annex 7 to this regulation, and

meets the requirements of this regulation which apply to it.



6.2. In the case of a medical device risk class IIa shall examine the

notified body as part of the assessment referred to in point 3. 1. up to 3. 3.

of this annex, the technical documentation referred to in point 2 of annex 7 to this

Regulation of at least 1 representative sample from each subgroup

medical devices in order to assess compliance with the provisions of this

of the regulation.



6.3. In choosing representative sample (s) notes the notified

the person in the account of the novelty of the technology, similarities in design, technology,

manufacturing and sterilisation methods, the intended use and the results of all

previous related reviews, in particular as regards the physical,

chemical and biological properties, which was carried out in accordance with the

This regulation. Notified body shall document and must, for

the competent administrative authority reasons for choosing representative sample

samples.



6.4. Further samples shall be assessed as part of the supervision of the notified body

According to paragraph 4. 3.2. of this annex.



7.



Batch release



After completing the manufacture of each batch of a medical device, which

contains, as an integral part, a substance, which can be

used alone, considered to be a medicinal product constituent or a medicinal product

product derived from human blood or human plasma, in the case that

its action is only an additional effect to the effect

medical device, the manufacturer shall inform the person of the certification

the release of this batch of medical device and shall forward to it official

certificate concerning the release of the batch of human blood derivative used

in the medical device issued by the competent laboratory designated for

this purpose by the Member State, in the Czech Republic in accordance with the law on

pharmaceuticals.



Annex 6



EC declaration of conformity



Quality assurance of medical device



1.



1.1. The manufacturer ensures the implementation and operation of the quality system

approved for the final inspection and testing by a competent medical

resource under points 2 and 3 of this annex and shall be subject to surveillance as specified in point 4

of this annex.



1.2. In the case of a medical device marketed in a sterile

the State claims the manufacturer points 2 to 4 of annex 5 to this

Regulation, and only for the properties of the process intended for

secure and maintain sterility.



1.3. Medical device quality assurance is part of the procedure,

which the manufacturer, who shall proceed in accordance with point 1. 1. this annex provides

and declares that the medical device conforms to the type

as described in the type-examination certificate and satisfies the requirements of this

the regulation, which is applicable to it.



1.4. The manufacturer affixes the CE marking medical device in accordance with the

§ 6, where the CE marking is accompanied by the identification number of the notified

the person who is involved in the conformity assessment, draws up and maintains

written declaration of conformity.



1.5. The Declaration of conformity shall be drawn up for one or more produced

clearly marked medical devices called medical

the resource code, medical device or other unique

by reference.



2.



The quality system



2.1. The manufacturer shall submit a written request to the notified person assessment

evaluation and approval of their quality system.



2.2. The request contains



2.2. 1. the name or business name and the address or registered office address

the main business establishment, where appropriate, place of residence, if the manufacturer

is a natural person; the name or business name and address of the registered office, in the case of

the legal entity,



2.2. 2. the required information on the medical device or category

medical devices, which are covered by the quality system,



2.2. 3. a written declaration that the notified body on the other has not been submitted

application for assessment of his quality system for the same medical device



2.2. 4. the quality system documentation,



2.2. 5. an undertaking to proceed in accordance with the approved system

the quality,



2.2. 6. an undertaking to maintain the approved quality system in

applicable and efficacious,



2.2. 7. where appropriate, the technical documentation of the approved type and

a copy of the type-examination certificate,



2.2. 8. an undertaking shall implement and update systematic

procedure to review experience gained from medical devices

placed on the market, including the clinical trial in accordance with the law on

medical devices; part of this commitment, the manufacturer is

to report adverse events to the Institute, and it promptly, but not later than

15 days from the date of their findings and further and appropriate way to implement

the necessary corrective measures.



2.3. The manufacturer's quality system in the framework of this



2.3. 1. examine any medical device or a representative

a sample from each batch,



2.3. 2. carry out the appropriate tests as set out in the corresponding

harmonised standard, or equivalent tests, to make sure that the

medical device corresponds to the type described in the certificate of

type-examination certificate and satisfies the requirements laid down in this regulation that apply to

it, and



2.3. 3. systematically and properly documents all the

the elements, requirements and provisions, in the form of written measures, procedures

and instructions.



2. the 4. The documentation must allow uniform interpretation of the quality plan program

quality manuals and quality records.



2.5. The documentation contains adequate description



2.5. 1. the objectives of the quality specified by the manufacturer,



2.5. 2. organizational structures, responsibilities and powers of the managerial

staff in terms of production quality,



2.5. 3. the examination and testing of the medical device when the

manufacture; must be able to adequately trace the accuracy of

the calibration of the test equipment,



2.5. 4. the methods of monitoring the effectiveness of the quality system,



2.5. 5. quality records, primarily of the inspection reports, reports of the

test and calibration and the qualifications of the staff concerned, and



2.5. 6. where the production and/or final inspection and testing of the medical

the device or its parts is performed by a third party, the methods of monitoring the

the effective operation of the quality system, and the type and range checks

carried out by over a third party.



2.6. The checks referred to in point 2. 5.6. This annex shall not apply to the part of the

the manufacturing process designed to secure sterility.



3.



Audit



3. the 1. Notified body must audit the quality system to the manufacturer with the

to determine if the system satisfies the requirements laid down in points 2. 3. up to

2.6. of this annex. Compliance with these requirements shall be presumed for systems

quality, in which the use of harmonized standards.



3.2. In a team responsible for assessment of the quality system must be at least

one Member, who has experience with the assessment of the relevant technologies.

Evaluation procedure includes a check of the premises of the manufacturer, and in

duly substantiated cases, control of the production processes in the operating

vendor spaces of the manufacturer.



3.3. Notified body shall notify the manufacturer, after completion of the audit system

the quality of the result, which must contain the conclusions of the inspection and

a reasoned assessment.



3.4. The manufacturer shall inform the person who approved the certification system

the quality, of the intention to significantly change this system. Notified body

shall evaluate the changes proposed and verify whether after these changes the quality system

still complies with the requirements referred to in points 2. 3. up to 2. 6. of this annex

and shall notify the manufacturer of its decision to the manufacturer that must contain the conclusions

the inspection and a reasoned assessment.



4.



Supervision



4. the 1. The aim of surveillance is to ensure that the manufacturer duly fulfils the requirements

arising out of the approved quality system.



4.2. The manufacturer allows the notified person access to control,

testing and storage spaces that are used in the manufacture of

medical device, and provides the appropriate person notified

information, in particular



4.2. 1. the quality system documentation,



4.2. 2. the technical documentation, and



4.2. 3. data defined quality system for the production area

medical devices, especially the inspection report, the results of

and test data, calibration data, and reports on the qualifications of the relevant

employees.



4.3. Notified body performs



4.3. 1. appropriate examinations and assessment periodically, so that the

make sure that the manufacturer applies the approved quality system, and provides a

inspection and assessment report




4.3. 2. at its discretion, well in advance of unannounced checks

in which, if necessary, carry out or have carried out tests for

to check that the quality system is effective and properly manufacture

the medical device conforms to the requirements of this regulation.



4.4. During the checks referred to in point 4. 3.2. of this annex, shall be verified

an adequate sample of medical devices manufactured for the removed

manufacturer certification, and appropriate tests shall be carried out according to the

the relevant harmonized standards or shall be equivalent to

of the test. If one or more of the samples do not match, the

notified the appropriate measures. Notified body shall provide the

the manufacturer with a visit report and, if tests have been carried out and the test

the message.



5.



Retention of documents



The manufacturer of the medical device or his authorised representative

at the disposal of the competent administrative authorities for a period of at least 5 years

from the date of manufacture of the medical device



5.1. Declaration of conformity,



5.2. the documentation referred to in point 2. 2. the 4. of this annex,



5.3. changes in accordance with point 3. 4. of this annex,



5.4. the decisions and reports of the notified body referred to in points 3. 4., 4. 3.

4.4. of this annex,



5.5. where appropriate, the certificate of conformity referred to in annex 3 to this regulation.



6.



The application procedures for medical device risk class IIa



6.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this

Annex applied for medical device risk class IIa with

by way of derogation from points 1. 3. up to 1. 5. (a) 2 of this annex on the basis of

Declaration of conformity the manufacturer ensures and declares that the medical

resource risk class IIa is made in accordance with the technical

documentation referred to in point 2 of annex 7 to this regulation and complies with the

the requirements of this regulation which apply to it.



6.2. In the case of a medical device risk class IIa shall examine the

notified body as part of the assessment referred to in point 3. 1. up to 3. 3.

of this annex, the technical documentation referred to in point 2 of annex 7 to this

Regulation of at least one representative sample from each subgroup

medical devices in order to assess compliance with this regulation.



6.3. In choosing representative sample (s) notes the notified

the person in the account of the novelty of the technology, similarities in design, technology,

manufacturing and sterilisation methods, the intended use and the results of all

previous related reviews, in particular as regards the physical,

chemical and biological properties, which was carried out in accordance with the

This regulation. Notified body shall document and must, for

the competent administrative authority reasons for choosing representative sample

samples.



6.4. Further samples shall be assessed as part of the supervision of the notified body

According to paragraph 4. 3. the 1. of this annex.



Annex 7



EC declaration of conformity



The basic conformity assessment



1.



Basic assessment of conformity is the procedure whereby the manufacturer or his

authorised representative, who shall proceed in accordance with section 2 of this annex, and in

the case of the medical device placed on the market in a sterile condition

or a medical device with a measuring function shall proceed in accordance with point 4

of this annex ensures and declares that the medical

the resource meets the requirements of this regulation which apply to it.



2.



The technical documentation



2.1. The manufacturer shall establish the technical documentation must enable the

assessment of the conformity of the medical device with the requirements of this regulation.



2.2. Technical documentation shall contain, in particular,



2.2. 1. General description of the medical device, including all

variants planned, and its intended purpose,



2.2. 2. design drawings, manufacturing technology and

schemas, subassemblies, or circuits,



2.2. 3. the descriptions and explanations necessary for the understanding of the above

drawings, diagrams and the function of the medical device,



2.2. 4. the results of the risk analysis and a list of the harmonised standards

used in full or in part, and descriptions of the solutions approved for

meet the essential requirements where the harmonised standards are not applied

in its entirety,



2.2. 5. in the case of a medical device marketed in the

sterile condition, description of the methods used and the validation report,



2.2. 6. the results of the design calculations and of the inspections carried out; If

to meet the intended purpose of the device is to be combined with other

medical device, where appropriate, with other health

resources, it must be demonstrated that the medical device meets the

the basic requirements in connection with the medical device or

other medical devices that have properties specified

by the manufacturer,



2.2. 7. the solutions adopted according to part I, point 2 of annex 1 to this

Regulation,



2.2. 8. preclinical evaluation,



2.2. 9. a clinical trial according to the law on medical devices,



2.2. 10. medical device labeling and instructions for its use in

the Czech language.



2.3. The manufacturer of the medical device or his authorised representative

must for at least 5 years from the date of manufacture of the medical

resource to keep at the disposal of the competent authorities, the technical

documentation and the latest version of the written declaration of conformity.



3.



Obligation after the placing on the market



The manufacturer shall establish and update a systematic procedure to review

the experience gained from medical devices placed on the market,

including the clinical trial in accordance with the law on health care

resources. Part of this commitment, the manufacturer is notified to the Institute

adverse events, and it promptly, but not later than within 15 days from the date of

their findings, and on and in an appropriate manner to implement the necessary corrective

measures.



4.



Application of the procedures for sterile medical device and

medical device with measuring functions



4. the 1. For medical device placed on the market in a sterile State and

for medical device risk class I with measuring function, the manufacturer

adheres to in addition to the provisions of this annex as well as one of the procedures referred to in annex

2, 4, 5 or 6 to this regulation.



4.2. Application of the procedures and measures of the notified body referred to in no attachments.

2, 4, 5 or 6 to this Regulation shall be confined in a medical device



4.2. 1. put on the market in sterile condition, only the aspects of production,

touching the provisioning and maintaining sterile conditions,



4.2. 2. with a measuring function, only the aspects of production, which are related to the

This happens to be a medical device with the metrological requirements



and you can apply the provisions of point 5 of this annex.



5.



The application procedures for medical device risk class IIa



5.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this

Annex applied for medical device risk class IIa with

by using this annex in connection with the procedure according to annexes 4,

5 or 6 to this Regulation shall be the Declaration of conformity pursuant to those

attachments to a single declaration of conformity.



5.2. In the Declaration of conformity is drawn up pursuant to this annex,

the manufacturer ensures and declares that the medical device design

meets the requirements of this regulation which apply to it.



Annex 8



Statement on medical devices for special purposes



1.



Declaration of individually made medical device



1.1. The manufacturer or his authorised representative shall draw up on individually

medical device made a statement.



1.2. The Declaration contains



1.2. 1. the name or business name and the address or registered office address

the main business establishment, where appropriate, place of residence, if the manufacturer

is a natural person; the name or business name and address of the registered office, in the case of

the legal entity,



1.2. 2. the data allowing identification of the medical

resource,



1.2. 3. a statement that the medical device is designed exclusively

for a particular user, together with an indication of his name and surname,



1.2. 4. name of medical practitioner or other authorized person, that issued the

a prescription to this medical device and the name or business

name and address of the provider of health care services,



1.2. 5. specific properties of medical device, as they are

listed in the medical prescription,



1.2. 6. a statement that the medical device meets the

the basic requirements, where necessary, details of which of these fundamental

requirements are not fully met, including in the preamble.



1.3. The manufacturer of a medical device made of individually leads and

exposes the relevant administrative authorities individually documentation

made of medical device and makes the necessary arrangements to

ensure that from its production process is based on an individually prepared

a medical device in accordance with that documentation.



1.4. The documentation referred to in point 1. 3. this annex contains the



1.4. 1. the place or places of production,



1.4. 2. information that allows to understand the design, manufacture and performance

the eligibility of a medical device, in order to assess the conformity with the

the requirements of this regulation.



1.5. The manufacturer shall take all necessary measures to ensure that the manufacturing process


ensures compliance of the manufactured medical device documentation

in accordance with point 1. 4 of this annex.



1. the 6. Manufacturer evaluates and documents the experience gained with the

individually-crafted medical devices after their transmission

the patient to use, including the evaluation of information relating to the

clinical trial according to the law on medical devices.

Part of this commitment, the manufacturer is notified to the Institute of adverse events,

and it shall, without delay, but not later than within 15 days from the date of their findings and

Furthermore, an appropriate way to implement the necessary corrective measures.



2.



Statement of medical device intended for clinical investigation



2.1. The manufacturer or his authorised representative shall draw up on healthcare

a resource intended for clinical investigations the statement.



2.2. The Declaration contains



2.2. 1. the data allowing identification of the medical

resource,



2.2. 2. the clinical investigation plan,



2.2. 3. the investigator's brochure,



2.2. 4. the confirmation of insurance of subjects,



2.2. 5. the documents used to obtain informed consent,



2.2. 6. a statement that the device incorporates, as an integral

part, a substance or human blood derivative referred to in section 8. 5. annexes

# 1,



2.2. 7. a statement whether the device is manufactured utilising tissues of

of animal origin as referred to in section 4 of this regulation,



2.2. 8. the opinion of the Ethics Committee and the details of the

aspects, which are covered by this opinion,



2.2. 9. the name of the medical practitioner or other authorized person and of the institution responsible for

clinical trials,



2.2. 10. the place, starting date and scheduled duration of clinical trials,



2.2. 11. a statement that the device complies with the essential requirements

In addition to the aspects, which are the subject of clinical trials, and with a view

on this point of view has taken all the precautionary measures for the protection of

the health and safety of the patient.



2.3. The manufacturer makes the relevant administrative authorities with documentation

medical device intended for clinical investigation.



2. the 4. The documentation of the medical device intended for clinical

the test described in point 2.3. contains



2. the 4. 1. a general description of the medical device and its intended purpose,



2. the 4. 2. design drawings, manufacturing technology estimated,

in particular as regards sterilization, and diagrams of components, sub-assemblies and

circuits,



2. the 4. 3. the descriptions and explanations necessary for the understanding of said drawings and

schemes and the operation of the medical device,



2. the 4. 4. the results of the risk analysis and a list of the harmonised standards

were used wholly or in part, and descriptions of the solutions adopted to meet the

the essential requirements of this regulation, if not used

harmonised standards,



2. the 4. 5. If a medical device incorporates, as an integral

part, a substance or human blood derivative referred to in section 8. 5. annexes

No 1 to this regulation, the data on the tests conducted in this

connection required to assess the safety, quality and usefulness of

of that substance or human blood derivative, taking account of the intended purpose of the

medical device,



2. the 4. 6. If a medical device is manufactured utilising tissues of

animal origin referred to in paragraph 4, the risk management measures in this

the context that was applied in order to reduce the risk of transmission

the disease,



2. the 4. 7. the results of the design calculations, checks,

technical tests.



2.5. The manufacturer shall take all measures necessary to ensure that

the result of the production process was a medical device which corresponds to the

the documentation referred to in point 2. 4.



2.6. The manufacturer shall permit an assessment or audit of the effectiveness of these

measures.



3.



Documentation and declarations referred to in this annex shall be kept for a period of

at least 5 years and in the case of implantable devices at least 15

years of age.



Annex 9



The classification rules



(I).



Basic concepts



1.



For the purposes of this annex, means the



1.1. temporary duration of continuous use of the medical device

After a period of less than 60 minutes,



1.2. the short duration of continuous use of the medical device

for less than 30 days,



1.3. the long-term duration of continuous use of the medical device

For more than 30 days,



1.4. body hole natural opening in the body, including the external surface

the eyeball or permanent, artificially created opening,



1.5. invasive medical device medical device

that completely or in part, penetrates inside the body through a body orifice or the surface

of the body,



1. the 6. invasive medical device surgically invasive

medical device which penetrates inside the body using his surface

surgical intervention or in connection with the



1.7. implantable medical device medical device

to be totally introduced into the human body or to replace

the epithelial surface or the surface of the eye surgery, after which the

remain in place; for implantable medical device is also

a medical device shall be deemed to be the surgical procedure

partially introduced into the human body, and after the procedure there remain at least 30

days,



1.8. a surgical instrument for the repeated use of a tool designed to

surgical use by cutting, drilling, sawing, scratching, scraping,

retracting, the scent, switching and similar practices, which is not associated

with active medical device and can be after the execution

of the processes used,



1. the 9. active medical device medical device, which

activity depends on a source of electrical energy or any source that is not directly

created by the human body or gravity and which acts via

converting this energy; medical devices intended to transmit energy

or substances between active medical device and the patient without

any significant change for active medical device

not be considered; separate software is considered to be active

medical device,



1.10. Active therapeutical device any active medical device

whether used alone or in combination with other medical devices

to support, modify, restore, or modify biological functions

or structures with a view to treatment or alleviation of disease, injury or

disability,



1.11. Active diagnostic medical device active

medical device, whether used alone or in combination with other

medical devices, to supply information to diagnose,

monitoring, detection or treatment of a physiological state, State of health,

diseases or birth defects,



1.12. Central circulatory system the following vessels: arteriae pulmonales,

the aorta, transverse, arcus aortae aorta descendens to the bifurcatio, aortae,

arteriae coronariae, arteria carotid communis, arteria carotid externa,

internal carotid artery, arteriae cerebrales, truncus

brachiocephalicus, venae cordis, venae pulmonales, vena cava superior,

vena cava inferior,



1.13. central nervous system-the brain, the brain's diapers and backbone

spinal cord,



1.14. Endoprosthesis of the hip, knee and shoulder Endoprosthesis Endoprosthesis

The implantable components of total hip replacements, whose task is to

provide a function similar to a natural hip joint, the natural

the knee joint, a natural shoulder joint; This definition is

not apply to ancillary components such as screws, wedges, plates or

Tools.



II.



DETAILED RULES



2.



Detailed rules



2.1. The classification rules shall be governed by the intended purpose of medical

resource.



2.2. If the medical device is intended to be used in combination with

other medical device, the classification rules shall apply for

each device separately.



2.3. Accessories are classified separately from the medical

the resource with which it is used.



2. the 4. Software, which drives a device or influences the use of

medical device belongs to the same class as the this

medical device.



2.5. If there is a medical device designed exclusively or principally to the

use for a specific part of the body, it and is classified by the

the principle of the most critical specified use.



2.6. If the classification of a medical device for several

rules based on the performance of this medical

resource and intended purpose specified by the manufacturer, the

the most stringent rules in the higher risk class.



2.7. In the calculation of the period referred to in point 1. 1. up to 1. 3. of this annex

continuous use means the actual continuous use

medical device for the purpose intended. However, if you use

the medical device is interrupted for the purpose of instant Exchange

the medical device with the same or identical medical

the resource, it is considered a continuation in continuous use

the medical device.



III.



CLASSIFICATION



3.



Classification of non-invasive medical device



3. the 1. Rule 1



Non-invasive medical device belongs to a risk class I, if

subject to rule no. 2, 3 or 4.



3.2. Rule 2




Non-invasive medical device intended for draining or

the collection of blood, body liquids or tissues, liquids or gases for

the eventual infusion, administration or introduction into the body belongs to a risk

class IIa



3.2. 1. can be connected to an active medical device

risk class IIa or a higher class of risk, and



3.2. 2. is designed for evacuation or collect blood or other

body liquids or for storing organs, parts of organs or body

tissue; in all other cases, belongs to a risk class I.



3.3. Rule 3



Non-invasive medical device intended for the modification of biological or

the chemical composition of blood, other body liquids or other liquids

intended for infusion into the body are in class IIb risk; If treatment

consists of filtration, centrifugation or exchanges of gas or heat, include

such a medical device to a risk class IIa.



3.4. Rule 4



Non-invasive medical device which comes into contact with

injured skin, belongs to the



3.4. 1. risk class I, if it is intended to be used as a mechanical

barrier, for compression or for absorption of exudates,



3.4. 2. risk class IIb if it is designed especially for use in healing,

where was breached and where you may have only a secondary therapeutic

the effect,



3.4. 3. risk class IIa in all other cases, including the

the medical device from the specified, in particular for the treatment of micro-environments

the wound.



4.



Invasive medical device classification



4. the 1. Rule 5



Invasive medical device intended to be used for natural

body orifices, other than surgically invasive medical device and

for connection to an active medical device or specified by the

for connection to an active medical device risk class I belong

to



4. the 1. 1. risk class I, if it is intended for temporary use,



4. the 1. 2. risk class IIa is intended for short-term use,

with the exception of use in the oral cavity as far as the pharynx, in an ear canal up to the ear

drum or in a nasal cavity, which belong to a risk class I,



4. the 1. 3. risk class IIb if it is intended for long-term use,

with the exception of use in the oral cavity as far as the pharynx, in an ear canal up to the ear

drum or in a nasal cavity and are not likely absorption

mucous membranes, which belong to a risk class IIa; invasive medical

a resource that relates to body orifices and that is not surgically

invasive medical device and is intended for connection to an active

medical device in class IIa or a higher risk, belongs to the

risk class IIa.



4.2. Rule 6



Any kind of a surgically invasive device for

transient use are in class IIa unless risk is not



4.2. 1. intended specifically to control, diagnose, monitor or correct a

defect of the heart or of the Central circulatory system through direct contact with these

parts of the body, which belongs to the risk class III,



4.2. 2. surgical tool for reuse, which belongs to the

risk class I,



4.2. 3. specially designed for direct contact with the central nervous system,

When it belongs to a risk class III,



4.2. 4. intended to supply energy in the form of ionizing radiation in which

It belongs to a risk class IIb,



4.2. 5. intended to have a biological effect or to be full or the vast

absorption, which belong to a risk class IIb,



4.2. 6. intended to administer medicinal products dosing system, if

This is done in a way to potentially dangerous in terms of the way

the application, which belongs to the risk class IIb.



4.3. Rule 7



Surgically invasive device for short-term use

It belongs to a risk class IIa, if is not intended



4.3. 1. particularly for the control, diagnose, monitor or correct

heart defects or defects in the Central circulatory system through direct contact with

these parts of the body, which belongs to the risk class III,



4.3. 2. specifically for use in direct contact with the central nervous

system, in which belong to a risk class III,



4.3. 3. to supply energy in the form of ionizing radiation in which belongs to the

risk class IIb,



4.3. 4. to have a biological effect or to be wholly or full

absorption, which belong to a risk class III,



4.3. 5. to undergo chemical change in the body, with the exception of the medical

a resource in the teeth, or to administer medicines, in which belongs to the

risk class IIb.



4.4. Rule 8



Implantable and long-term surgically invasive medical

a resource belongs to a risk class IIb if is not intended to



4.4. 1. location in the teeth, which belong to a risk class IIa,



4.4. 2. the use in direct contact with the heart, the Central circulatory or

the central nervous system, which belong to a risk class III,



4.4. 3. have a biological effect or to be wholly or mainly absorbed,

When it belongs to a risk class III,



4.4. 4. undergo chemical changes in the body, with the exception of the medical

a resource in the teeth, or to administer medicines, in which belongs to the

risk class III.



5.



Active medical device classification



5.1. Rule 9



5.1. 1. active therapeutic medical device intended for feed

or power exchange belongs to the risk class IIa if they are not

properties such that, having regard to the nature, the density and site of application

energy energy to the human body or pass through or out of the body

Exchange in potentially harmful ways, which belongs to the class of risk

IIB.



5.1. 2. Active medical device designed to control or

monitor the performance of active therapeutic medical devices

risk class IIb, or intended directly to influence the effectiveness of such

medical devices belongs to the risk class IIb.



5.2. Rule 10



Active medical device intended for diagnosing belongs to

risk class IIa, if it is intended to



5.2. 1. the administration of the energy that is absorbed by the human body, with the

the exception of a medical device used to illuminate the patient's

the body, in the visible spectrum,



5.2. 2. view the in vivo distribution of radiopharmaceuticals,



5.2. 3. direct diagnosis or monitoring of vital

physiological processes, unless it is specifically designed for monitoring

the vital physiological parameters, where the nature of variations is such,

that could lead to an imminent threat to the user (changes in heart

performance, respiration, activity of the central nervous system), which belongs to the

risk class IIb; active medical device intended to emit

ionizing radiation and intended for diagnostic and therapeutic

Interventional Radiology, including medical device that controls the

or monitor such medical devices or directly affects the

their performance, belongs to a risk class IIb.



5.3. Rule 11



Active medical device designed to administer drugs, body

liquids or other substances into the body or the removal of pharmaceuticals, body

liquids or other substances from the body belongs to a risk class IIa, if

not in a manner that is potentially hazardous taking account of the

the nature of the used substances, parts of the body and the manner of application, include

to a risk class IIb.



5.4. Rule 12



Active medical device which does not comply with paragraphs 5. 1.-5. 3.

of this annex, belongs to a risk class I.



6.



Special classification of the medical device



6.1. Rule 13



6.1. 1. A medical device that includes as an integral part, a substance,

that when used alone, can be considered a drug, and that

can act on the human body effect of complementary effect of the medical

a resource belongs to a risk class III.



6.1. 2. a medical device which incorporates, as an integral

part of the human blood derivative, belongs to a risk class III.



6.2. Rule 14



Medical device used for contraception or for the prevention of

transmission of sexually transmitted diseases belongs to a risk class IIb,

If it is not implantable or long term invasive medical

the means by which belong to a risk class III.



6.3. Rule 15



Medical device specifically intended to be used for disinfecting,

cleaning, rinsing, or hydrating contact lenses, belongs to the

risk class IIb. Medical device specifically intended for use

for disinfecting medical devices belongs to the risk class IIa,

If it is not specifically intended for disinfecting invasive medical

resources, which belong to a risk class IIb; This does not apply for products

intended for the physical cleaning of medical devices that are not

contact lenses.



6.4. Rule 16



Medical device specifically intended for the recording of diagnostic

x-ray view belongs to a risk class IIa.



6.5. Rule 17



Medical device made with the use of animal tissues or

non-living derivatives belong to the high-risk class III, with the exception of


a medical device that is intended to come into contact only with intact

the skin.



6.6. Rule 18



Blood bag belongs to a risk class IIb.



6.7.



Breast implants belongs to a risk class III ^ 10)



6.8.



Hip, knee and shoulder belongs to a risk class III ^ 11).



Annex 10



The criteria for the certification the person



1. the notified body, its statutory authority, the employees and the other persons

carrying out its activities (hereinafter referred to as "employees") responsible for the

the assessment and verification operations may not be the authors of the proposal, manufacturers, suppliers

Neither installers or user of the devices which they inspect, and

they may not be nor the authorised representative of any of those parties. Shall not

directly involved in the design, construction, marketing or maintenance of the devices,

nor represent the parties participating in these activities. This, however,

does not preclude the possibility of exchanges of technical information between the manufacturer and the

entity.



2. the notified body and its staff shall carry out the assessment and

verifications with the highest degree of professional integrity and the requisite

competence in the field of medical devices and must be

exposed to pressures and inducements, particularly financial, which might

influence their judgement or the results of the inspection, especially from persons

or groups of persons, in the result of verifications.



2.1. Subcontract specific tasks connected with the establishment

and verification of the facts, the notified body must first ensure that the

the subcontractor meets the provisions of this regulation, and in particular the

of the annex. Notified body shall keep at the disposal of the national authorities

the relevant documents assessing the subcontractor's qualifications, and job

done under this regulation.



3. the notified body must be able to perform all the tasks that

This person are designed by one of annexes 2 to 7 and for which the

notified, either by itself or on its responsibility.

Notified body must have at its disposal the necessary staff and, in particular,

have the necessary facilities to enable it to perform properly the technical and administrative

tasks connected with the assessment and verification. The assumption is that

notified body will have available sufficient scientific personnel

facilities with sufficient experience and knowledge necessary to assess the

medical performance and efficiency of those funds, for

that has been notified, having regard to the requirements of this regulation, and in particular

the requirements of annex 1 to this regulation. It must also have access to

the equipment necessary for the verifications required.



4. the notified body shall ensure that the



4. the 1. sound vocational training covering all the assessment and verification

the procedures for which it was named,



4.2. satisfactory knowledge of the rules on the inspections which are carried out, and

adequate experience of such tests,



4.3. the ability required to draw up the certificates, protocols and

reports to demonstrate that the inspections have been carried out.



5. Must be guaranteed the impartiality and independence of the notified body. Her

remuneration must not depend on the number of inspections carried out, nor on their

the results.



6. the notified body shall conclude, in accordance with the Act on technical

the Treaty requirements for products liability insurance.



7. the staff of the notified body shall preserve the confidentiality of all

information obtained in the performance of their duties under the law on

technical requirements for products.



8. Additional requirements for the certification the person lays down the right to use

Regulation of the European Union ^ 12).



1) Council Directive 93/42/EEC of 14 June 1993 June 1993 on medical

of transport, as amended by European Parliament and Council Directive 98/79/EC

of 27 June. October 1998, the European Parliament and Council Directive 2000/70/EC

of 16 December 2002. November 2000, directive of the European Parliament and of the Council

2001/104/EC of 7 September 2004. December 2001, regulation of the European Parliament and of the

Council Regulation (EC) No 1882/2003 of 29 September 2003. September 2003 and directive of the European

Parliament and Council Directive 2007/47/EC of 5 July 2004. September 7, 2007.



2) of Decree-Law No. 21/2003 Coll., laying down technical requirements

on personal protective equipment.



3) Act No. 18/1997 Coll. on peaceful uses of nuclear energy and

ionizing radiation (the Atomic Act), and amending and supplementing certain

laws, as amended.



4) § 2 (2). 2 Government Regulation No. 616/2006 Coll., on technical

requirements for products in terms of their electromagnetic

compatibility.



5) of Decree-Law No. 176/2008 Coll., on technical requirements for mechanical engineering

device.



6) Section 4a of the Act No. 22/1997 Coll., on technical requirements for products and on the

amendments to certain laws, as amended.



7) European Parliament and Council Regulation (EC) no 765/2008 of 9 July.

July 2008 setting out the requirements for accreditation and supervision of

market related to the marketing of products and repealing Regulation

(EEC) No 339/93.



8) Law No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws, as amended.



9) Act No. 506/1990 Coll., on weights and measures, as amended.



Decree No. 264/2000 Coll., on the basic measuring units and other

units and their labelling, as amended by Decree No. 424/2009 Sb.



10) Commission Directive 2003/12/EC on the reclassification of breast implants in the

framework of Directive 93/42/EEC on medical devices.



11) Commission Directive 2005/50/EC on the reclassification of hip,

the knee and shoulder joint in the framework of Council Directive 93/42/EEC on

medical devices.



12) Commission Regulation (EC) No 920/2013 for the designation of notified bodies

pursuant to Council Directive 90/385/EEC on active implantable

medical devices and Council Directive 93/42/EEC concerning medical

resources and supervision of such bodies.