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.
