Technical Data. Requirements For Active Implantable Medical Devices

Original Language Title: techn. požadavky na aktivní implantabilní zdravotnické prostředky

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=83851&nr=55~2F2015~20Sb.&ft=txt

55/2015 Sb.



GOVERNMENT REGULATION



of 25 June 2002. March 2015



on technical requirements for active implantable medical

resources



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. 102/2001 Coll., Act No. 204/2002 Coll.

Act No. 34/2007 Coll., Act No. 100/2013 Coll. and Act No. 64/2014 Sb.

(hereinafter referred to as the "law on technical requirements for products") to implement section 2

(a). (d)), section 11 (1) 1, 2 and 9, section 11a. 2, section 12 and 13 of the law on

technical requirements for products and in accordance with § 96 para. 1 of law No.

268/2014 Coll., on medical devices and on the amendment of Act No.

634/2004 Coll., on administrative fees, as amended,

(hereinafter referred to as the "law on medical devices") to implement section 5 (b).

l) of the Act 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 active

implantable medical devices. This Regulation shall also apply to

active implantable medical devices intended to administer a substance,

that is a medicinal product within the meaning of the law on medicinal products.



§ 2



The General principles of



(1) the active implantable medical device must comply with the

essential requirements referred to in annex 1 to this Regulation (hereinafter referred to as

"essential requirements"), which apply to specific active implantable

medical device and taking account of its intended

the purpose of the.



(2) in assessing the active implantable medical device

with regard to its electromagnetic compatibility does not flow under the

Government Regulation, laying down technical requirements for the products of

with regard to their EMC ^ 2).



(3) where there is a risk, the active implantable

medical devices which are also machinery,

also comply with the essential requirements for the protection of health and safety

set out in government regulation on technical requirements on mechanical engineering

device ^ 3) where these are essential requirements to protect the health and

the safety of the more specific than the essential requirements.



(4) the essential requirements shall be considered satisfied if the active

implantable medical device is in accordance with the requirements of

harmonised standards ^ 4) that this medical device

apply with regard to its intended use. For the purposes of this

the regulation includes a reference to harmonised standards also monographs

Of the European Pharmacopoeia notably 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.



§ 3



The conformity assessment procedures



(1) for the active implantable medical device which is not

individually made or intended for clinical investigations, the manufacturer before

the CE marking shall be assessed the conformity of the measure, taking into account the intended

the purpose of the procedure laid down in



and full security system quality) referred to in annex 2 to this

Regulation, or



(b) a type-examination in accordance with annex) No. 3 to this regulation, in conjunction with the

the procedure for verification in accordance with annex 4 to this regulation, or

procedure for quality assurance of production referred to in annex 5 to this

of the regulation.



(2) for the active implantable medical device, which was

conformity in accordance with paragraph 1, the manufacturer shall issue prior to its

placing on the market a written declaration of conformity in accordance with the annex to

application of this regulation.



(3) in the case of individually made active implantable medical

resource issues the manufacturer before placing on the market or putting into service of a written

Declaration referred to in annex 6 to this regulation.



(4) by way of derogation from paragraphs 1 to 3, the 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 individual active implantable

medical device for which the procedure has not been performed in accordance with paragraphs

1 to 3 and the use of which is in the interest of protection of health.



(5) the procedures set out in annexes 3, 4 and 6 of this Regulation may, instead of

the manufacturer performed its authorized representative.



(6) the records and correspondence relating to the procedures referred to in paragraphs

1 to 4 shall be in the English language or in a language, on which shall be agreed

notified body with a manufacturer, or his authorized

representative.



(7) when assessing the conformity of the active implantable medical

device manufacturer, the authorised representative or notified body

taking into account the results of any assessment and verification operations carried out in

If necessary, in accordance with this regulation in the left of the

process.



(8) If a conformity assessment procedure for the active implantable

medical device includes the participation of the notified body, the manufacturer

or his authorised representative so requests for conformity assessment by notified

the person of your choice with the corresponding scope of authorization and

notification.



(9) 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.



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

issued in accordance with annexes 2, 3 and 5 to this Regulation shall be valid

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

a maximum of 5 years, on the basis of an application made at the time at which both parties

agreed in the contract signed by both parties.



(11) 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 No 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.



§ 4



The CE Marking



(1) the manufacturer shall affix the active implantable medical device which

not individually made and is not intended for clinical trials and

meets the requirements of this regulation, prior to its placing on the market

and/or put into service, a CE marking which graphic design provides for directly

applicable regulation the European Union ^ 5).



(2) the CE marking active implantable medical device

referred to in paragraph 1 shall be placed in a visible, legible and indelible form on the

the sterile packaging of the active implantable medical device,

the instructions for its use, where appropriate, on the sales packaging.



(3) the CE marking active implantable medical device

referred to in paragraph 1 shall be accompanied identification number of the notified body

responsible for carrying out the operations provided for by the Act on health care

resources and annexes 2, 4 and 5 to this regulation.



(4) on the packaging of the active implantable medical device or on

instructions attached to this resource you can mention other indications only

will not be reduced, provided that the visibility and legibility of the CE marking. On

active implantable medical device cannot connect brands and

inscriptions which are likely to mislead third parties as to the meaning and

the CE marking.



(5) where an active implantable medical device is subject to the

other aspects of the specific legislation, which lays down the obligation to

to affix the CE marking, in such a case this term that

active implantable medical device is in accordance with

the requirements that apply to it under these specific legal

regulations.



(6) However, where one or more 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.



(7) the active implantable medical device which is not provided with

the CE marking, or does not meet the requirements of this regulation or of the law on

medical devices can be exhibited at trade fairs,

exhibitions, demonstrations, and other similar events, for

provided that a visible sign clearly indicates that such

the resource cannot be placed on the market or put into service until brought into

accordance with this regulation and with the law on medical devices.



§ 5



Placing on the market and putting into service



(1) on the market or putting into service can be active implantable medical

resource given, 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

active implantable medical device complies with the requirements

of this regulation and is properly installed, maintained and used in accordance

for their intended purpose, is provided with the CE marking, meets the requirements of

referred to in this paragraph and paragraphs 2 and 3, and the manufacturer has issued about

a written declaration ("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) in the Czech Republic is an active implantable medical device

intended for clinical investigation available specialists or an authorized

persons, if it complies with the conditions set out in section 14 of the Act on

medical devices and in annex 6 to this regulation.



(3) Individually made active implantable medical

a resource can be placed on the market and/or put into service, if it was

conformity in accordance with annex 6 to this regulation and to individually

the active ingredient implantabilnímu medical device was

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

to a particular patient.



(4) an active implantable medical device intended for clinical

tests and individually prepared active implantable medical

the CE marking shall be neopatřuje.



§ 6



Notified body



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

requirements for products shall apply the requirements set out in annex # 7

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 5 to this regulation.



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

the requirements of this regulation, or no longer satisfies, or if

the certificate should not be issued, notified body, taking into account the

the principles of proportionality, suspends, withdraws or restricts the use of the certificate,

which was released, with the exception of cases, when 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 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 7 to this regulation.



§ 7



Transitional provisions



(1) active implantable medical device is placed on the market before

date of entry into force of this regulation in accordance with the existing laws,

regulations shall be considered as active implantable medical device

placed on the market in accordance with this regulation.



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

conformity assessment according to the Government Regulation No 154/2004 Coll., as amended by

amended, shall be regarded as authorized and notified body

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



§ 8



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.



Prime Minister:



Mgr. Sobotka in r.



Minister of health:



Mudr. Němeček, MBA, in r.



Annex 1



The basic requirements



(I).



General requirements



1. an active implantable medical device must be designed and

designed to provided his implanted 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, or

other persons, provided that any risks which may

the intended purpose of this active implantable medical

the resource to be related, are acceptable in comparison with its benefit

of the patient. Active implantable medical device may not

pose no risk to the persons to whom it is implanted, where appropriate, for

other natural persons.



2. an active implantable medical device must be designed and

manufactured to the performances intended by the manufacturer and has been

suitable for one or more of the functions referred to in the Act on health care

resources and in accordance with the manufacturer's specifications.



3. When you load the active implantable medical device,

that may occur under normal operating conditions, there must be

adversely affected the characteristics and performances referred to in

points 1 and 2 of this annex, to the extent that it might endanger health

or safety of a patient or user or other persons,

over the life of the medical device indicated by the manufacturer.



4. Active implantable medical device shall be designed,

manufactured and packaged so that, under the conditions laid down by the manufacturer for its

storage and transport could be adversely affected by its properties, and

performance requirements.



5. each side effect and unwanted State can only represent

acceptable risk compared with the effects of the active point

implantable medical device.



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

reviews pursuant to the law on medical devices.



II.



Design and construction requirements



7.



Chemical, physical and biological properties



7.1. The level of safety of the active implantable medical

the resource must match the State of science and technology at the time of placing on the

market, this request must match the solutions adopted by the manufacturer at their

the design and construction.



7.2. Active implantable medical device shall be designed,

manufactured and packaged in packaging for single-use the appropriate procedure, so that the

After putting on the market remained sterile and this property has retained during

storage and transport under the conditions laid down by the manufacturer, until the

During implantation.



7.3. Active implantable medical device must be designed and

made so as to be excluded or limited to the lowest possible level

the risk of



7.3. 1. physical injury in connection with its physical

characteristics,



7.3. 2. related sources of energy, use of electric

energy, especially with regard to insulation, leakage currents status, if applicable

overheating of the active implantable medical device,



7.3. 3. connected with reasonably foreseeable environmental conditions,

in particular, magnetic fields, external electrical influences,

electrostatic discharge, pressure and its changes and Acceleration,



7.3. 4. associated with the treatment, resulting in particular from the use of

defibrillators and high-frequency surgical equipment,



7.3. 5. associated with ionizing radiation of radioactive substances used in

active transport in accordance with the radiation protection requirements according to the

special legislation ^ 6), and



7.3. 6. which may arise due to the fact that the active

implantable medical device cannot maintain or calibrate

including risks originating in



7.3. 6.1. from excessive zoom down conductor currents,



7.3. 6.2. from the ageing of the materials used,



7.3. 6.3. from the excessive heat produced by active implantable

medical device, and



7.3. 6.4. of the reduced accuracy of any measuring or control mechanism.



7.4. Active implantable medical device must be designed and

designed to guarantee the characteristics and performances

referred to in points 1 to 6 of this annex, with special focus on



7.4. 1. the choice of materials used, particularly with regard to toxicity,



7.4. 2. mutual compatibility between the materials used and

biological tissues, cells and body fluids, taking account of the

intended use active implantable medical

resource,



7.4. 3. compatibility of the active implantable medical

resource with substances that are to be administered by them,



7.4. 4. the quality of the links, in particular with regard to safety,



7.4. 5. the reliability of the source of energy,



7.4. 6. the tightness, if applicable, and



7.4. 7. the proper functioning of the programming and control systems, including

software.




7.5. For the active implantable medical device, which

contains the software or which is itself the programme

equipment, software must be validated according to the latest

knowledge, taking into account the principles of development lifecycle management

risks, validation and verification.



7.6. The provisions for medical devices with integrated medicine

or derivative of human blood



7.6. 1. where an active implantable medical device contains

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

the use of the medicinal product considered in accordance with the law on pharmaceuticals ^ 7), and

that can act upon the body with action ancillary to that of the active

implantable medical device, must be quality, safety

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

the law on pharmaceuticals.



7.6. 2. For the substances referred to in point 7. 6.1. of this annex, the notified

the person after you verified the usefulness of the substance as part of the active

implantable medical device and taking account of the intended

the purpose of the active implantable medical device requests

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

the risk-benefit ratio of the authenticated for the incorporation of the substance into the

active implantable medical device from one of the

the competent authorities of the Member States or from the European Medicines Agency

products (hereinafter referred to as "the Agency"). If the opinion is issued by the State Institute of

for drug control (hereinafter referred to as "the Institute"), takes into account the production methods and

information about the usefulness of incorporation of the substance into the active implantable

medical device, which notified body.



7.6. 3. If an active implantable medical device incorporates,

as an integral part, a human blood derivative, the

notified body having verified the usefulness of the human blood derivative

as part of the active implantable medical device and with

taking account of the intended purpose of the active implantable medical

resource expert opinion of the Agency on the quality and safety of this

human blood derivative, including clinically certified risk

benefits of integrating human blood derivative into the active

implantable medical device.



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

the active implanatbilního of the medical device, in particular

about its manufacturing process, must be informed about the changes notified

the person who requests the expert opinion of the relevant competent authority,

which issued the original expert opinion to confirm that the quality and

additional safety is maintained. If the expert opinion

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

substances into the active implantable medical device, which

said the notified body in order to ensure that the changes do not have any

negative impact on clinically validated risk-benefit ratio when

the inclusion of this additional substance in the medical device.



7.6. 5. If the institution that issued the original expert opinion, it receives

information on additional substance, that could have an impact on clinically

the risk-benefit ratio, certified in its integration into the active

implantable medical device, the notified person shall notify the

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

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

active implantable medical device or not.

Notified body shall take account of the updated scientific opinion when you

reviewing its conclusion from the conformity assessment procedure.



Information provided by the manufacturer



8.



8.1. Active implantable medical device, where applicable, its

parts are marked so that the necessary measures can be taken, when

determine the potential risk that is associated with this device or its

parts.



8.2. Active implantable medical device is equipped with a code

enabling unique identification of an individual resource and its

manufacturer. This code must be readable in case of necessity without the need

the surgical procedure.



8.3. If you are in an active implantable medical device

or its accessories listed instructions required for its operation or

Visual information for setting or action of this resource must be

the following information to understand the provider of health services in the case

appropriate, the patient.



9.



The active implantable medical device shall be indicated legibly

and indelibly the following information:



9.1. on the sterile pack



9.1. 1. the method of sterilization,



9.1. 2. the permitting this packaging for the sterile,



9.1. 3. the name or business name and the address of the registered office or the address of the

the main business establishment, or place of residence, if the manufacturer

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

the manufacturer is an entity,



9.1. 4. Description of the active implantable medical device,



9.1. 5. the inscription "exclusively for clinical investigations ', when it comes to Active

implantable medical device intended for clinical investigation,



9.1. 6. the inscription "Individually prepared active implantable

medical device ", in the case of individually prepared

active implantable medical device,



9.1. 7. the Declaration of sterilitě of this resource,



9.1. 8. month and year of production, and



9.1. 9. the time limit for implanting this device,



9.2. on the sales packaging



9.2. 1. in the case of the authorised representative, in the event that the manufacturer is not established in the

one of the Member States, shall indicate the name or business name and address of the

the address of the registered office or principal place of the business establishment, or

residence, if the authorised representative is a natural person; the name or

business name and address of the registered office, if the authorised representative is

legal person,



9.2. 2. Description of the device



9.2. 3. intended purpose of its use,



9.2. 4. the relevant characteristics for its use,



9.2. 5. the inscription "exclusively for clinical investigations ', when it comes to Active

implantable medical device intended for clinical investigation,



9.2. 6. the inscription "Individually prepared active implantable

medical device ", in the case of individually made active

implantable medical device



9.2. 7. Declaration of his sterilitě,



9.2. 8. month and year of manufacture,



9.2. 9. the time limit for implanting this device,



9.2. 10. the conditions for transport and storage of the device,



9.2. 11. indicate that the active implantable medical device

contains a human blood derivative, referred to in the Act on health care

resources,



9.3. the information referred to in points 9. 1. and 9. 2. in this annex, may be

and reflected by appropriate symbols specified in the harmonised standards,



9.4. active implantable medical device must be

placing on the market comes with an instruction manual in the English language, which

contains



9.4. 1. the year of conformity assessment pursuant to this regulation for the purposes of the measures

the CE marking,



9.4. 2. the data referred to in points 8. 4., 8. 5.1. up to 8. 5.7. and 8. 5.10. This

of the annex,



9.4. 3. details of the performances referred to in annex 1, point 2, to the

of this regulation and any undesirable side-effects,



9.4. 4. information allowing the physician to select a suitable active

implantable medical device, the appropriate software

and accessories, and



9.4. 5. information that is included in the instructions for use, and which

allow doctors and the patient as needed to properly use this

resource, its accessories and software, and further information

on the nature, extent and frequency of operational controls and tests, in the case of

i need instructions for the maintenance,



9.4. 6. information about how to prevent the risks associated with its

implantation, if applicable,



9.4. 7. information about the risk of side effects on this resource,

as a result of the interaction of this resource and equipment

present at the time of the investigation of the health status or treatment

natural persons,



9.4. 8. the necessary instructions for violations of sterile packaging

resource, and the information on the appropriate manner of its new sterilization, if

applicable,



9.4. 9. indication that the resource may be reused only after

its renovation on the responsibility of the manufacturer to meet the essential

requirements, if this possibility comes into consideration and



9.5. instructions allowing the physician to acquaint the patient with contraindications and

precautions to be taken, in particular,



9.5. 1. the information, by which you can specify the lifetime of the energy source,



9.5. 2. measures in case of changes in the performance of

This resource,



9.5. 3. measures in case of exposure to magnetic fields in the vicinity

Active acceleration, pressure and its changes, or other negative

influences on this resource, if these effects can be reasonably

assume,




9.5. 4. adequate information on medicinal products, to be this

means served, and



9.5. 5. the date of issue or the date of the last revision of the instructions for use,



9.6. the Declaration that the active implantable medical device,

used in accordance with the intended purpose of use and under the conditions laid down

by the manufacturer, conform to the essential requirements referred to in this annex; When

the evaluation of the side effects is based on the clinical data generated

According to the law on medical devices.



Annex 2



EC declaration of conformity



The full quality assurance system



1.



1.1. The manufacturer ensures for the design, manufacture and final product inspection

active implantable medical device application

approved quality system in accordance with points 2, 3 and 4 of this annex.



1.2. The quality system shall be subject to surveillance as specified in point 5 of this annex. System

full quality assurance is the procedure whereby the manufacturer, or

authorized representative acting commitments by section 1 ensures and

declares that the active implantable medical device

meets the requirements of this regulation.



1.3. The manufacturer, or authorised representative ensures the active implantable

medical device CE marking and identification number

the relevant notified body.



1.4. The manufacturer or his authorized representative, shall draw up a written declaration of

compliance, which is to be kept. This privacy statement applies to one

or more active means exactly identified the name of the active

implantable medical device, product code activated

implantable 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

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, the address of the place of residence if the manufacturer

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

the manufacturer is a legal person, where appropriate, the name or trading name, or

the name and address of the authorised representative where the manufacturer does not have a

registered office in a Member State,



2.2. 2. all information concerning active implantable medical

the resource whose production is assumed



2.2. 3. the quality system documentation,



2.2. 4. warranty the manufacturer to comply with the obligations arising

from the quality system as approved,



2.2. 5. manufacturer's warranty to maintain a quality system in a usable and effective

State, and



2.2. 6. an undertaking shall implement and update systematic

procedure to obtain and evaluate information and user experience

obtained with active they are implantable 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 under the law on health care

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



2.3. The application of the quality system ensures the quality of production of active

implantable medical device so that this made

resource to conform with the provisions that apply to it from this

Regulation, at every stage of its design to final inspection.



2. the 4. The elements, requirements and provisions adopted by the manufacturer for his applied

the quality system must be documented in the form of a systematic and

written policies and procedures that enable their uniform interpretation,

in particular, quality records, quality programmes, quality plans and manuals

the quality. This includes in particular the corresponding documentation, data and records

arising from the procedures referred to in point 2. 5.3.



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



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



2.5. 2. the Organization of the business establishment and production activities by the manufacturer,

in particular, the



2.5. 2.1. the organizational structure, definition of the responsibility of Heads of

employees and their powers in relation to the design and quality of production

active implantable medical device,



2.5. 2.2. the methods of monitoring the effectiveness of the quality system and in particular its

the ability to achieve the desired quality of design and produced the active

implantable medical device, including the disposal of this

the active implantable medical device, which required

the quality is less than,



2.5. 2.3. where the design, manufacture and/or final inspection and testing

active implantable medical device or its parts

performed by a third party, the methods of monitoring the efficient operation of the system

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

person,



2.5. 3. the procedures for monitoring and verifying the design of the active

implantable medical device, in particular



2.5. 3. the 1. the design specifications, including the harmonised standards

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

valid for active implantable medical device, if they are not

harmonised standards are not applied in full,



2.5. 3.2. methods of examination and verification of designs, processes and systematic

the measures that will be used when designing the active

implantable medical device,



2.5. 3.3. a statement of whether active implantable medical

the device incorporates, as an integral part, a substance or a

human blood as mentioned in point 7. 6.3. Annex 1 to this regulation, and

the data on the tests conducted in this connection which are required to

assess the safety, quality and usefulness of that substance or derivative of

human blood, taking account of the intended purpose of the use of the active

implantable medical device,



2.5. 3.4. the pre-clinical evaluation,



2.5. 3. the 5. clinical trial under the law on health care

resources,



2.5. 4. methods of control and ensure the quality of the active implantable

medical device in the stage of its production, in particular



2.5. 4. the 1. the methods and procedures that will be used for sterilization and

the purchase, including the relevant documents,



2.5. 4.2. active implantable identification procedures

medical device produced and updated to all the stages

production on the basis of drawings, specifications and other relevant

documents,



2.5. 4.3. 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 and



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

the production, during and after the production of the active implantable

medical device, their frequency and the test device.



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

the quality that use the corresponding harmonised standards system

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

one member with experience of assessing the relevant technologies.

Part of the assessment is to audit the manufacturer's premises and, in the

duly substantiated cases, on the premises to inspect the manufacturing processes

suppliers or contractors by the manufacturer.



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

the quality of its decision, which shall contain the conclusions of the examination and

a reasoned assessment.



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

the quality of any plan to change this system. Notified body

shall evaluate the changes proposed and verify whether after these changes the quality system

complies with the requirements referred to in point 2. 3. of this annex and shall notify its

the decision of the manufacturer. This decision must contain the conclusions of the inspection and

a reasoned assessment.



4.



Examination of the design



4. the 1. The manufacturer so requests, in addition to its obligations under points 2 and 3 of this

Annex, the person on the assessment of the dossier relating to the

the design of active implantable medical device which is in

intends to produce.



4.2. The request contains next to the data in paragraph 2.2.1. of this annex.



4.2. 1. the design, manufacture and performances of the active

implantable medical device and contains documents needed

to assess whether the active implantable medical device

meets the requirements of this regulation, and in particular points 2. 5.3. and 2. 5.4.

of this annex,



4.2. 2. design specification, including applied harmonised standards,



4.2. 3. the necessary evidence for the adequacy of harmonized standards, in particular

If harmonised standards are not applied in full; This evidence

contain results of appropriate tests carried out by the manufacturer or its

responsibility,



4.2. 4. a statement that the active implantable medical device

contains or does not contain an integral part, a substance referred to in section 7. 6.


Annex 1 to this regulation, which, together with this

device may result in its bioavailability, together with data on

carried out the corresponding tests,



4.2. 5. the clinical evaluation in accordance with the law on medical devices,



4.2. 6. the draft instructions for the use of the active implantable

the medical device.



4.3. Notified body shall examine the application, and if the active

implantable medical device meets the requirements of this

Regulation, the EC design-examination certificate to the applicant. Notified body

a person may request, in its sole discretion, to complete the request more

or evidence that will allow the assessment of conformity of the active

implantable medical device with the requirements of this regulation.

EC design examination certificate contains the conclusions of the examination, the conditions of

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

active implantable medical device, where applicable, a description of the

intended purpose of the active implantable medical device.



4.4. In the case of the active implantable medical device

referred to in point 7. 6.3. Annex 1 to this regulation

notified body, in accordance with point 7. 6.3. Annex No. 1 to this

Regulation, before taking a decision on the scientific opinion of one of the

the competent authorities designated by the Member States, the Czech Republic, Institute of

or the Agency. If the expert opinion required the Institute, shall draw up

expert opinion within 210 days after the date of receipt of the complete documentation.

Expert opinion of the competent authority of the Member State or the Agency

must be included in the documentation relating to active implantable

the medical device. Notified decisions

This pays due attention to the opinion and its final

the decision shall inform the institution which issued this scientific opinion.



4.5. In the case of the active implantable medical device

referred to in point 7. 6.4. Annex 1 to this Regulation shall be

the professional opinion of the Agency included in the documentation concerning the

active implantable medical device. Notified body

When taking a decision to the opinion of the agency pays the appropriate

attention. Notified body shall not issue a certificate, if the professional

the Agency's adverse opinion. Notified its final

decision shall be communicated to the Agency.



4.6. The manufacturer shall inform by the person who issued the certificate, the EC

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

implantable medical device. If such changes would

could affect conformity with the essential requirements or with the conditions

prescribed for the use of the active implantable medical

the resource, these changes are subject to additional approval by the notified body

the person who has issued the EC design examination certificate. This additional

change the certificate takes the form of a supplement to the original of the certificate of

a review of the proposal.



5.



Supervision



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

arising out of the approved quality system.



5.2. By the notified body, the manufacturer shall authorize a person to perform the necessary checks

and provide it with the relevant information, in particular



5.2. 1. the quality system documentation,



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

such as results of analyses, calculations, tests, preclinical and clinical

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

into operation and, where appropriate, the results of subsequent clinical monitoring and more

the eventual result,



5.2. 3. the data on a dedicated quality system for the production of the active area

implantable medical device, in particular reports of

inspections, testing, standardization, calibration and qualification of the relevant

employees.



5.3. Notified body shall periodically carry out inspections and assessment,

to make sure that the manufacturer applies the approved quality system and

provides a report on the assessment of the manufacturers.



5.4. Notified body may carry out checks to the manufacturer, and

provide the manufacturer with a visit report.



6.



Retention of documents



6.1. For at least 15 years from the date of manufacture of the active

implantable medical device, the manufacturer or his

authorized representative shall keep at the disposal of the competent authorities



6.1. 1. a declaration of conformity,



6.1. 2. the documentation of the quality system in accordance with section 2. 2.3. of this annex,

and in particular the documentation, data and records referred to in point 2. 4. this

of the annex,



6.1. 3. documentation of the changes referred to in section 3. 2. of this annex,



6.1. 4. the documentation referred to in point 4. 2. of this annex,



6.1. 5. certificates and other documents of the notified body referred to in points 3.

2., 4. 3. and 5. 3. of this annex.



6.2. Notified body shall, on request of the competent authorities, to the Office,

where appropriate, the other notified parties with adequate information about

issued, refused or withdrawn certificates of the quality system.



7.



Batch release



After completing the manufacture of each batch (hereinafter referred to as "lot") of the active

implantable medical device that contains your

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, the manufacturer shall inform the person of the batch release certification

such an active implantable medical device and shall forward to it

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

in this active implantable medical 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 3



EC type-examination



1.



Type-examination active implantable medical device

certification is the procedure whereby a notified body ascertains and

certifies that a representative specimen of the considered production Active

implantable medical device (hereafter named the type) satisfies the

the relevant provisions of this regulation that apply to it. In

connection with the manufacturer ensures and declares that the active

implantable medical device on the market matches the supplied

certified type.



2.



Procedure the manufacturer



2.1. The manufacturer, or authorised representative so requests by

person type examination.



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 or home address, 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 or business name and the address of the registered office or the address of the

the main business establishment, where appropriate, the address of the place of residence of the authorised

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

registered office, if the request is submitted by a legal person,



2.2. 3. documentation that is needed to assess the conformity of the type with the

the requirements of this regulation; the applicant must 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 is processed so as to enable understanding of the design,

production and performance of active implantable medical

resource and contains



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 above

drawings and diagrams and the operation of the active implantable medical

resource,



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 device incorporates, as an integral

part, a substance or human blood derivative referred to in section 7. 6. Annex

No 1 to this regulation, and 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

resource,



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. preclinical evaluation,



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

and



2.3. 10. design of the leaflet.



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 the documentation. Notified body

also recorded all of its components, which are designed in accordance with the

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

the following harmonised standards are not designed.



3.2. Notified body shall carry out or have carried out the inspection or

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

the basic requirements in accordance with this regulation, if not used

harmonised standards.



3.3. Notified body shall carry out or have carried out the inspection 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 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

the dossier, a copy kept by the notified body.



4.2. EC type-examination certificate contains



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

the main business establishment or home address, 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 the active implantable medical device

referred to in point 7. 6.2. Annex 1 to this regulation

notified body, in accordance with point 7. 6.2. Annex No. 1 to this

Regulation, before taking a decision on the scientific opinion of one of the

the competent authorities designated by the Member States, the Czech Republic, Institute of

or the Agency. If the expert opinion required the Institute, shall draw up

expert opinion within 210 days after the date of receipt of the complete documentation.

Scientific opinion of the institution or Agency must be included in the

documentation relating to active implantable medical

resource. Notified body when adopting decision devoted to this

the opinion of the appropriate attention and its final decision to

the entity that this expert opinion.



4.4. In the case of the active implantable medical device

referred to in point 7. 6.3. Annex 1 to this Regulation shall be

the professional opinion of the Agency included in the documentation concerning the

active implantable medical device. Notified body

When taking a decision to the opinion of the agency pays the appropriate

attention. Notified body shall not issue a certificate, if the professional

the Agency's adverse opinion. Notified its final

decision shall be communicated to the Agency.



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 all modifications,

that the approved active implantable medical device

has made.



5.2. Changes to the approved active implantable medical

the resource must receive further approval by the person who

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

active implantable medical device. Additional

approval takes the form of Supplement to the initial EC examination certificate

type.



6.



The transmission and retention of documents



6.1. Notified body provides other notified persons and

to the competent authority designated by the Member State, on request,

relevant information concerning the issued, refused or withdrawn

the type-examination certificates and their additions.



6.2. Other notified body or the competent authorities may, after the submission of the

reasoned request, obtain a copy of the type-examination certificate,

where appropriate, their additions; before you can access these certificates and

their additions other notified parties on their application

informed of the manufacturer.



6.3. The manufacturer, or authorised representative must keep with the

the technical documentation a copy of the type-examination certificates and their

additions for a period of at least 15 years after the manufacture of the last active

implantable medical device, and also for the need for

of the competent authorities.



Annex 4



EC verification



1.



Verification of the conformity of the active implantable medical device is

the procedure whereby the manufacturer, or authorised representative ensures and

declares that the active implantable medical device that has been

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 active implantable medical

the device with the type described in the type-examination certificate and with the

the requirements that apply to it from 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 shall undertake to Institute and keep updated a systematic

the procedure for obtaining and evaluating information, and user experience

obtained with active they are implantable medical devices, which

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.



3.



How to obtain



Notified body carry out the appropriate examinations and tests in order to verify the

the conformity of the active implantable medical device with the requirements of

This regulation by examination and testing of these funds on the basis of

statistical methods as specified in point 4 of this annex. The manufacturer shall authorise the

by a person to assess the effectiveness of the measures taken in accordance with point

2.2. of this annex, if necessary, on the basis of an audit.



4.



Statistical verification



4. the 1. The manufacturer shall submit to the active implantable medical device in

uniform batches and shall take all measures necessary in order that the manufacturing

process ensures the homogeneity of each lot.



4.2. Notified body removes the randomly selected from each batch.

Active implantable medical devices that make up the pattern,

notified body individually checked by appropriate tests

referred to in the harmonised standards or by performing the equivalent

of the tests. When examining the second sentence is verified the conformity of the active

implantable medical device with its approved type

as described in the type-examination certificate for the purpose of adoption or

the rejection of the lot.



4.3. Statistical verification juxtaposition or active 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

Active resources.



4.4. If the notified body lot



4.4. 1. adopts, affix or have on every active

implantable medical device your identification number and shall issue to the

written certificate of conformity with reference to the tests carried out; Active

implantable medical device from a lot taken over could be listed

on the market with the exception of active implantable medical

the resource in the selected sample, which was found wanting,



4.4. 2. rejects the appropriate measures in order to prevent

putting this lot on the market; in the case of repeated refusal to release is

notified body may suspend the statistical verification.



4.5. The manufacturer may place already during the production process on the packaging

produced by the active implantable medical device

the identification number of the notified body, which is responsible for the

statistical verification on its responsibility.



4.6. The manufacturer or his authorised representative ensures the presentation of

the certificates referred to in point 4. 4.1, drawn up by the notified body.

person, on request of the competent authority.



5.



Batch release



After completing the manufacture of each batch of active implantable

a medical device that includes as an integral part

a substance which, when used alone, may be considered to be a folder


a medicinal product or a medicinal product derived from human blood or

human plasma, in the case that its action is only an additional

the effect to that of the medical device, the manufacturer shall inform the

by a person on the release of the batch of active implantable

medical device and shall forward to it a certificate concerning the release of

a batch of human blood derivative used in this active implantable

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 5



EC declaration of conformity



Production-quality assurance



1.



1.1. The manufacturer uses the system approved for the manufacture of quality assurance

active implantable medical device and makes the output

control of the active implantable medical device referred to in point

2 of this annex. The manufacturer shall be subject to surveillance as specified in point 4 of this annex.



1.2. Declaration of conformity to type is the procedure whereby the manufacturer

performing the obligations referred to in point 1. 1. this annex ensures and declares that the

the active implantable medical device conforms to the type

as described in the type-examination certificate and meets the provisions of this

regulations that apply to it.



1.3. The manufacturer or his authorised representative ensures the active

implantable medical device CE marking in accordance with § 3 and 4

and draw up a written declaration of conformity. This statement holds

manufacturer.



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

active devices shown to be identified called the active

implantable medical device, the active code

implantable 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

its 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 or home address, 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. relevant data about active transport, the production of which is

assumes



2.2. 3. the quality system documentation,



2.2. 4. guarantee the fulfilment of the obligations arising from the approved system

the quality,



2.2. 5. the warranty maintenance of the approved quality system adequate and

efficacious,



2.2. 6. the technical documentation of the approved type and a copy of the certificate of

type-examination, if applicable,



2.2. 7. an undertaking shall implement and update systematic

procedure to review experience gained with active they are implantable

medical devices placed on the market, including clinical reviews

in accordance with the law on medical devices; part of this

the manufacturer's obligation is to notify the Institute of adverse events, and without delay,

However, at the latest, within 15 days from the date of their findings.



2.3. Applicable quality system ensures that the active implantable

medical device corresponds to the type described in the certificate of

type-examination.



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 the quality of the active implantable

medical device and procedures, in particular the quality programmes, plans,

quality manuals and quality records.



2.5. The quality system documentation shall describe



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 production of active implantable

medical device,



2.5. 2.2. the methods of monitoring the efficient operation of the quality system,

in particular its ability to achieve the desired quality of the active

implantable medical device, including the active

implantable medical device that required quality

it reaches,



2.5. 2.3. If production or final inspection and testing of the active

implantable medical device or its parts performed by a third

person, the methods of monitoring the efficient operation of the quality system and in particular the

the method and extent of the checks carried out by over a third party,



2.5. 3. the inspection and quality assurance techniques, active implantable

medical device in the stage of its production, in particular



2.5. 3. the 1. the methods and procedures that will be used in terms of

sterilization, purchasing and the relevant documents,



2.5. 3.2. How to identify the active implantable

medical device produced and retained in the updated

status at all stages of production on the basis of drawings, specifications, and

other related documents,



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

during and after the production of the active implantable medical

resource, their frequency, and the test device.



3.



Audit



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

determine whether a quality system satisfies the requirements referred to in points 2.

3. and 2. 4. of this annex. Compliance with these requirements in

quality systems, which use the corresponding harmonised standards.



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 contains the conclusions of the inspection and the 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

circuit of active funds. Notified body shall evaluate the proposed

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

the requirements referred to in points 2. 3. and 2. 4. of this annex and its

the decision, which contains the conclusions of the inspection and a reasoned assessment,

shall notify the manufacturer.



4.



Supervision



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

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. the data on a dedicated quality system for the production of the active area

implantable medical device, in particular control message,

data on the tests, standards, calibration and qualification report

relevant staff.



4.3. Notified body performs



4.3. 1. on a regular basis, where appropriate,



4.3. 2. at its discretion, and unannounced inspection and assessment

so, to make sure that the manufacturer applies the approved quality system; about

These inspections and posuzováních manufacturers will provide a written report.



5.



Notified body provides other notified parties on their

request information about certificates issued, refused or withdrawn approval

quality systems.



6.



Batch release



After completing the manufacture of each batch of active implantable

a medical device that includes as an integral part

a substance which, when used alone, may be considered to be a folder

a medicinal product or a medicinal product derived from human blood or

human plasma, in the case that its action is only an additional

the effect to that of the active implantable medical device,

inform the manufacturer by the person for the release of this batch of active

implantable medical device and shall forward to it the official certificate

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

implantable medical device issued by the appropriate laboratory of the

designated for this purpose by the Member State, in the Czech Republic in accordance with the

the law on pharmaceuticals.



Annex 6



Statement of active implantable medical devices for

special purposes



1.



Declaration of individually made active implantable

medical device



1.1. The manufacturer or his authorised representative shall draw up on individually

no active implantable medical device 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 appropriate Active

implantable medical device,



1.2. 3. a statement that the active implantable medical


the resource is intended exclusively for a particular patient, together with the

last name,



1.2. 4. name of medical practitioner or other authorized person, that issued the

a prescription to this active implantable medical device

and the name or business name and address of the health care provider

the service, which will be the active implantable medical device

implant, if applicable,



1.2. 5. specific properties of the active implantable medical

resource, as listed in the medical prescription,



1.2. 6. a statement that the active implantable medical

the resource complies with the basic requirements of this regulation, where appropriate,

data from these basic requirements are not fully met, including

justification.



1.3. Manufacturer of individually made active implantable

medical device leads and exposes the relevant administrative

authorities documentation of the made-up individually active implantable

medical device and makes the necessary measures to ensure that the

its manufacturing process is based on individually made active

implantable medical device in accordance with the documentation.



1.4. The documentation referred to in point 1. 3.



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 the active implantable medical device to

be able to assess the conformity with 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 active implantable medical

resource with the documentation referred to in point 1. 4. of this annex.



1. the 6. Manufacturer evaluates and documents the experience gained with the

individually-crafted active they are implantable medical

resources after their transmission to the patient to use, including the evaluation of the

information related to a clinical trial under 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 appropriate way to implement the necessary

the corrective measures.



2.



Statement on the active implantable medical device is intended

for clinical investigation



2.1. The manufacturer or his authorised representative shall draw up on the active

implantable medical device intended for clinical investigation

statement.



2.2. The Declaration contains



2.2. 1. information identifying the appropriate Active

implantable medical device,



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. 7.6. Annex

No 1 to this regulation,



2.2. 7. a statement whether the device is manufactured utilising tissues of

of animal origin as referred to in § 3 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. Active implantable medical device documentation

intended for the clinical examination referred to in point 2. 3. this annex contains the



2. the 4. 1. General description of the active implantable medical

the 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, circuits,

etc.,



2. the 4. 3. the descriptions and explanations necessary for the understanding of the above

drawings and diagrams and the operation of the active environment,



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 if the harmonised standards have not been applied,



2. the 4. 5. where an active implantable medical device contains

as an integral part, a substance or human blood derivative, referred to in

point 7. 6. Appendix No. 1 to this regulation, the data on the tests

conducted in this connection required to assess the safety,

the quality and usefulness of that substance or human blood derivative, with

taking account of the intended purpose of the active implantable medical

resource,



2. the 4. 6. the results of the design calculations, carried out

the inspections and technical tests.



2.5. The manufacturer shall take all necessary measures to ensure that the manufacturing process

ensures compliance of the manufactured active implantable medical

resource with documentation in accordance with points 2. 4. of this annex.



2.6. The manufacturer can assess the effectiveness of these measures to approve,

where appropriate, the audit.



3.



Documentation and declarations referred to in this annex shall be kept for a period of

at least 15 years from the date of manufacture of the active implantable

the medical device.



Annex 7



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 ^ 8).



1) Council Directive 90/385/EEC of 20 December. June 1990 on the approximation of

laws of the Member States relating to active implantable

medical devices, as amended by Council Directive 93/42/EEC of 14 June.

June 1993 Council Directive 93/68/EEC of 22 December 1986. July 1993, regulation

The European Parliament and of the Council (EC) No 1882/2003 of 29 September 2003. September 2003 and


European Parliament and Council Directive 2007/47/EC of 5 July 2004. September 7, 2007.



2) § 2 (2). 2 Government Regulation No. 616/2006 Coll., on technical

requirements for products in terms of their electromagnetic

compatibility.



3) Decree-Law No. 176/2008 Coll., on technical requirements for mechanical engineering

equipment, as amended.



4) Section 4a of the Act No. 22/1997 Coll., on technical requirements for products and on the

amendments to certain laws.



5) 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 33/93.



6) 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.



7) Law No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws, as amended.



8) 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.