54/2015 Sb.
GOVERNMENT REGULATION
of 25 June 2002. March 2015
on technical requirements for medical devices
Government orders under section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Act No. 71/2000 Coll., Act No. 204/2002 Coll., Act No. 34/2007 Coll.
Act No. 100/2013 Coll. and Act No. 64/2014 Coll. (hereinafter referred to as "the law of
technical requirements for products ") for the implementation of paragraph 2 (a). (d)), section 11
paragraph. 1, 2 and 9, section 11a. 2, section 12 and 13 of the Act on technical
requirements for products and in accordance with § 96 para. 1 of law no 268/2014 Coll.
medical devices and amending Act No. 634/2004 Coll., on
administrative fees, as amended, (hereinafter referred to as "the law of
medical devices ") to implement section 5 (b). l) and section 6 (1). 1
(a). and the law on medical devices):
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provisions of the European Union ^ 1) and
regulates the technical requirements for fixed products.
(2) laid down under this regulation are products within the meaning of § 12 para.
1 (b). and) of the technical requirements for products medical
devices and their accessories.
(3) this Regulation shall not apply to
and) in vitro diagnostic medical devices and their
Accessories,
(b) active implantable medical devices).
§ 2
Definition of terms
For the purposes of this regulation, means a
and a subset of medical devices) health file
devices having a common area of the intended purpose or shared
technology,
(b)) a group of generic medical devices medical file
devices having the same or similar intended purpose or shared
the technology, which allows it to be classified generically without
taking into account the characteristics of a particular medical device.
§ 3
The General principles of
(1) a medical device shall meet the essential requirements referred to in
Annex 1 to this Regulation (hereinafter referred to as "basic requirements"), which
the specific medical device and taking account of
its intended purpose.
(2) if they are medical devices without prejudice to the other legal
the rules governing the technical requirements of the personal protective
resources ^ 2) ^ 3 and ionizing radiation), the use of these laws
It is not affected by this regulation. The basic requirements in terms of
electromagnetic compatibility are given concrete form for medical
resources in Appendix No. 1 to this regulation and in their assessment of the
not applicable government regulation, laying down technical requirements for
products in terms of their electromagnetic compatibility ^ 4).
(3) where there is a risk, the medical device which
It is also the machinery, also comply with the essential requirements of the
health and safety requirements set out in government regulation on technical
the requirements for machinery ^ 5) if it set out the basic
requirements are more specific than the essential requirements set out in this
of the regulation.
(4) the essential requirements shall be considered satisfied if a medical
the resource is in accordance with the requirements of harmonized standards ^ 6)
This medical device apply taking into account its
their intended purpose. For the purposes of this regulation includes a reference to
harmonised standards also the monographs of the European Pharmacopoeia, particularly
surgical sutures and on interaction between medicinal products and
materials used in medical devices, that these
preparations contain links which have been published in the official journal of the
Of the European Union.
§ 4
The conformity assessment procedures
(1) in the case of a medical device risk class I, which is not
individually made up a medical device or medical
device intended for clinical investigation, the manufacturer for its measures
the CE marking to be governed by the procedure laid down in annex 7 to this regulation.
(2) in the case of a medical device risk class IIa, which is not
individually made up a medical device or medical
device intended for clinical investigation, the manufacturer for its measures
the CE marking to be governed by the procedure laid down in annex 7 to this regulation in the
conjunction with the procedure laid down in
and # 4) of the annex to this regulation,
(b)) of annex 5 to this regulation, or
(c)) of annex 6 to this regulation.
Instead of the procedures referred to in points) to c) you can use the procedure described in paragraph
3 (b). and).
(3) in the case of a medical device risk class IIb, which is not
individually made up a medical device or medical
device intended for clinical investigation, the manufacturer for its measures
the CE marking to be governed by the procedure laid down in
and # 2) of the annex to this regulation, with the exception of points 8, 9 and 10, or
(b)) in accordance with annex 3 to this regulation, in combination with the procedure
According to the annex No. 4, 5 or 6 to this regulation.
(4) in the case of a medical device risk class III, that is not
individually made up a medical device or medical
device intended for clinical investigation, the manufacturer for its measures
the CE marking to be governed by the procedure laid down in
and # 2) of the annex to this regulation, or
(b)) Annex 3 to this regulation in conjunction with the procedure referred to in annex
No 4 or 5 to this regulation.
(5) before placing each individually made medical
product on the market or into service, the manufacturer shall, in accordance with Annex No. 8
to this regulation.
(6) by way of derogation from paragraphs 1 to 5, a Ministry of health on
the basis of a duly substantiated request to enable on the territory of the Czech Republic
placing on the market and putting into service of an individual medical device,
for which the procedure has not been performed in accordance with paragraphs 1 to 5 and the use of
It is in the interest of protection of health.
(7) when assessing the conformity of a medical device manufacturer,
authorized representative or notified body shall take account of the results of all
assessment and verification operations carried out, if necessary in
accordance with this regulation in the left of the production process.
(8) on the instructions of the manufacturer's authorised representative to initiate the procedure
According to annexes 3, 4, 7 and 8 of this regulation.
(9) If a conformity assessment procedure for a medical device
It includes the participation of the notified body, the manufacturer, or his authorised
representative so requests for conformity assessment by the person according to their own
selection with the corresponding scope of authorization and notification.
(10) the notified body may require, where duly justified, to request
any information or data necessary for establishing and maintaining
verification of conformity in view of the chosen procedure.
(11) the certificates issued by the certification and other decision
issued in accordance with annexes 2, 3, 5 and 6 to this regulation are
valid for a maximum period of 5 years and may be renewed for a further period in the
a maximum of 5 years, on the basis of an application submitted in time, the two
agreed in the contract signed by both parties.
(12) the documentation accompanying the medical device, the records
and correspondence relating to the procedures referred to in section 4 shall be in
Czech language or in another language acceptable to the certification
person.
(13) the conformity assessment procedures in terms of minimizing the risk of transmission
the disease transmissible spongiform encephalopathy (TSE) on a person shall be governed by
Commission Regulation 722/2012 on special requirements relating to the
the requirements set out in the Council directives 90/385/EEC and 93/42/EEC with
regard to active implantable medical devices and medical
devices manufactured utilising tissues of animal origin, as amended.
§ 5
A special procedure for systems and medical devices and kits for
implementation of sterilization
(1) for systems and kits of medical devices, section 4 shall not apply,
If it is not stipulated otherwise.
(2) any natural or legal person who puts medical
devices bearing the CE marking in order to place them on the market as a system
or in accordance with its intended purpose, shall draw up a statement in
stating that the
and he has verified the mutual compatibility of) medical devices referred to in
the instructions of their producers, and ensure that they operate in accordance with these
instructions,
(b) he has packaged the system or Kit) of medical devices and
the relevant information for the user, including instructions from the manufacturers
individual medical devices and
(c) any activity of the pertinent) methods of internal control and
inspections.
(3) are not complied with the requirements set out in paragraph 2, shall be deemed to
such a system, or a combination of medical devices under the medical
a resource that is subject to the procedure referred to in article 4.
(4) any natural or legal person who sterilised systems and
of the combination of medical devices referred to in paragraph 2 or other
CE-marked medical devices designed by their manufacturers to be
sterilised prior to use, with a view to their placing on the market, it chooses
one of the procedures referred to in annex No. 2 or 5 to this regulation. The use of the
These annexes and the activities of notified body shall be limited to the validation process
used to achieve sterility, lasting until the time of open or
damage to the sterile packaging. The person concerned shall draw up a statement in
which confirms that the sterilization has been carried out in accordance with the instructions
manufacturer.
(5) medical devices referred to in paragraphs 2 and 4 cannot be
an additional CE marking, but attached to them in accordance with the information
paragraphs 16 and 17 of annex 1 to this regulation, which contain the relevant
data producers completed medical devices. The Declaration
in accordance with paragraphs 2 and 4 shall be kept for at least 5 years
the competent administrative authorities.
§ 6
The CE Marking
(1) a medical device, with the exception of individually made
medical device and medical device intended for
Clinical exam that meets the requirements of this regulation,
before placing on the market and/or put into service, must affix the CE marking, the
graphic design provides for the directly applicable European Union ^ 7).
(2) If a medical device is the subject of the other aspects of the particular
the legislation, which lays down the obligation to affix the CE marking,
in this case, the sign that a medical device
It is in accordance with the requirements that apply to it under these
special legislation.
(3) However, if one or several of the legislation for a transitional
time concedes that the manufacturer has chosen, the provisions of which shall be governed,
CE marking shall indicate conformity only with the law, or the
their provisions applied by the manufacturer. In this case, must be in
documentation, notices or instructions required by the competent
legislation and accompanying the product, lists
used legislation and directives, as published in the
The official journal of the European Union, whose requirements were those legal
the provisions were taken.
(4) the CE marking is to be positioned in a visible, legible and indelible form on the
medical device or its sterile pack, where it is
practicable and appropriate, and on the instructions for use. If it is possible,
the CE marking shall be affixed on the packaging of the medical device, in which the
is sold.
(5) for the CE marking shall be accompanied identification number of the notified body,
who is responsible for compliance with the procedure, in accordance with the rules referred to in
Annexes 2, 4, 5 and 6 to this regulation.
(6) on the medical device, its packaging or the instructions accompanying the
medical device you can place another character, provided that it
is not reduced the visibility and legibility of the CE marking. On the medical
the resource cannot be to affix marks or inscriptions which are likely to mislead
third parties as to the meaning and form of the CE marking.
(7) medical device which is not provided with the CE marking, or
does not meet the requirements of this regulation or of the law on health care
resources can be exhibited at trade fairs, exhibitions,
demonstrations, and other similar events, provided that
a visible sign clearly indicates that this resource cannot be
on the market or put into service until brought into conformity with this
Regulation and the law on medical devices.
§ 7
Placing on the market and putting into service
(1) on the market or putting into service of a medical device may be listed,
If
and laid down with him) was the way its properties are conformity
essential requirements and the result of this assessment, it was found that
medical device corresponds to the requirements of this regulation and, where
properly installed, maintained and used in accordance with their intended
the purpose is to bear the "CE" marking, meets the other requirements referred to in § 3
paragraph. 1 to 3, and the manufacturer has issued a written statement about it (hereinafter referred to as
"Declaration of conformity"), and
(b)) were to him, accompanied by information on its use in the Czech language in the
accordance with this regulation.
(2) the medical device is intended for clinical investigations can be made available
persons carrying out clinical exam only, are subject to the conditions
provided for by the law on medical devices and annex 8 to
application of this regulation.
(3) Individually made medical device may be placed on
the market and/or put into service, if it have undergone conformity assessment in accordance with annex
# 8, and individually manufactured medical device was
accompanied by the statement referred to in that annex, which is available
to a particular patient.
(4) a medical device intended for clinical investigation and individually
made medical device with CE marking neopatřuje.
§ 8
Notified body
(1) the authorization of legal entities under the law on technical
requirements for products shall apply the requirements set out in annex No 10
to this regulation. Legal entities which meet the criteria laid down in
the relevant harmonized standards shall be considered as persons who satisfy
the relevant minimum criteria required to obtain credentials.
(2) the notified body and the manufacturer or his authorised representative to
pursuant to the agreement lays down the time limits for completion of the evaluation and validation
the activities referred to in annexes 2 to 6 of this regulation.
(3) If a notified body finds that the manufacturer has failed to fulfil the relevant
the requirements of this regulation or is longer, fulfilled, or if the certificate
not be published, notified, having regard to the principles of
adequacy, suspends, withdraws or restricts the use of the certificate, which
released, except in cases where the manufacturer ensure compliance with these
the requirements of the implementation of appropriate corrective measures. In the case of
suspension, withdrawal or any limitation on the certificate or in the
cases in which the intervention of the Authority may be needed for standards,
Metrology and testing (hereinafter referred to as "the authority"), notified body
inform the Office. The Office shall inform the other Member States
The European Union, Contracting States to the agreement on the European economic area,
Switzerland and Turkey (hereinafter referred to as "Member State") and the European Commission.
(4) the notified body shall inform the Office of any certificates issued, modified,
supplemented, suspended, withdrawn or refused and certificates
the notified body shall inform the other about suspended, withdrawn or
the refused certificates and, on request, about certificates issued.
Notified body shall make available, upon request, also any other relevant
information on issued certificates.
(5) the notified body shall provide to the Authority on request, all relevant
information and documents, including budgetary documents, to enable
verification of compliance with the criteria laid down in annex 10 to this regulation.
§ 9
Transitional provisions
(1) the medical device is placed on the market before the date of entry into force of
This regulation in accordance with the existing legislation, it is considered
medical device marketed in accordance with this regulation.
(2) Authorized and notified the person responsible for the activities in the
conformity assessment according to Decree-Law No 336/2004 Coll., as amended by
amended, shall be regarded as authorized and notified body
responsible for the activities of conformity assessment pursuant to this regulation.
§ 10
The effectiveness of the
This Regulation shall enter into force on 1 January 2000. April 2015.
Prime Minister:
Mgr. Sobotka in r.
Minister of health:
Mudr. Němeček, MBA, in r.
Annex 1
The basic requirements
(I).
General requirements
1. A medical device shall be designed and constructed so that, when
the use under the conditions and for the intended purpose does not undermine the clinical
condition or the safety of patients, or the safety and health of users,
where applicable, other persons, provided that any risks which
can with the intended purpose of a medical device to be related, are
acceptable in comparison with its benefit for the patient and the medical
resource corresponds to a high level of protection of health and safety. It
includes:
1.1. reduction, where possible, the risk of errors when using as a result
the ergonomic features of the medical device and the environment in
which can be a medical device being used and the
1.2. the assessment of the technical knowledge, experience, education and training
users, or even the health and physical condition of users for
that is a medical device designed.
2. the Solutions adopted by the manufacturer for the design and construction of the medical
resource must be in accordance with the principles of safety and with the current
the level of science and technology. When selecting the most appropriate solutions, the manufacturer
is based on the following principles in the following order:
2.1. eliminate or at least minimize all risks in a safe
the design and construction of the medical device,
2.2. to do so, where appropriate, the corresponding protective measures
including, if necessary, a warning against the hazards which cannot be
exclude,
2.3. inform the user about the persistence of risk as a result of failure to
the full perfection of the latest protective measures.
3. A medical device must achieve the performances intended
by the manufacturer and be designed, manufactured and packed in such a way that it was suitable for a
or more of the purposes of complying with the definition of a medical device in accordance with
the law on medical devices, and in accordance with the specifications
manufacturer.
4. when the load of the medical device, which can occur during normal
operating conditions must not be adversely affected by its
the characteristics and performances referred to in points 1, 2 and 3 of this annex to the
the extent that could endanger the health or safety of the patient
or user or other persons, for the lifetime of
indicated by the manufacturer of the medical device, if the manufacturer this time
It has specified.
5. A medical device shall be designed, manufactured and packed in such a way that
under the conditions laid down by the manufacturer for its storage and transport, as
in particular, temperature or humidity, could be adversely affected by the
its properties and performance.
6. each side effect of a medical device may pose
the only acceptable risk compared with the intended effects of the medical
resource.
7. demonstration of conformity with the essential requirements must include a clinical
reviews pursuant to the law on medical devices.
II.
Design and construction requirements
8.
Chemical, physical and biological properties
8.1. A medical device shall be designed and constructed so as to be
guarantee the characteristics and performances referred to in the General
requirements. Special attention should be paid to
8.1. 1. selection of materials intended for the manufacture and packaging of medical
resources, particularly in terms of toxicity and, where appropriate, flammability,
8.1. 2. mutual compatibility between the materials used and biological
tissues, cells and body fluids, taking account of the intended purpose, and
8.1. 3. results of the biofyzikálního or the model of research, whose
force has previously demonstrated.
8.2. A medical device shall be designed, manufactured and packed in such a way
to minimise the risk arising from the pollution side
substances and components of the radiation and their residues to users and persons
involved in the transport, storage and use of medical
resource in accordance with its intended purpose. Special attention should be
paid to the effect on the tissue, the time and the frequency of this action.
8.3. A medical device shall be designed, manufactured and packed in such a way
so that it can be safely used along with substances and gases with which the
comes into contact in normal use and practices.
8.4. In the case that the medical device is intended to administer medicinal products,
must be designed and constructed so that, when the specified purpose has been with these
medicinal products within the limits compatible provisions and limits governing this
medical device controls and to preserve its functional
capability in accordance with its intended purpose.
8.5. The provisions for medical devices with integrated medicine
or derivative of human blood
8.5. 1. If a medical device incorporates, as its
integral part, a substance, which can be used separately
considered to be a medicinal product and which is liable to act upon the body of complementary
effect to the effect of a medical device, must be quality, safety
and usefulness of that substance, verified by analogy using methods referred to in
the law on pharmaceuticals ^ 8).
8.5. 2. For the substances referred to in point 8. 5.1. of this annex, the notified
a person having verified the usefulness of the substance as part of the medical
device and taking account of the intended purpose of a medical device
requests the expert opinion on the quality and safety of the substance including
clinically certified risk-benefit ratio in the integration of the
a substance in a medical device from one of the competent authorities
the Member States or from the European Medicines Agency (hereinafter referred to
"the Agency"). If the expert opinion requested by the State Institute for
drug control (hereinafter referred to as "the Institute"), takes into account the manufacturing process and the
information about the usefulness of the inclusion of a substance in a medical device,
the notified body.
8.5. 3. If a medical device incorporates, as its
an integral part, a human blood derivative, the notified body
Having verified the usefulness of the human blood derivative as part of
the medical device and taking account of the intended purpose of the
the medical device expert opinion of the Agency on the quality and
the safety of this human blood derivative, including clinically certified
the risk-benefit ratio of the incorporation of the human blood derivative into the
the medical device.
8.5. 4. if carried out changes on additional substance incorporated into
a medical device, in particular as regards its manufacturing process,
must be informed about changes to the notified body, which requests the
expert opinion relevant competent authority that issued the original
expert opinion to confirm that the quality and safety of
additional substance is preserved. If the expert opinion required
Institute, takes into account the data related to the usefulness of incorporation of additional substances to
medical device, which notified body for the purpose of
ensure that the changes have no negative impact on clinically proven
the risk-benefit ratio in the inclusion of this additional substances to the
the medical device.
8.5. 5. If the Department, as appropriate, the competent authority which issued the
the original expert opinion, informed of additional substance that
could have an effect on a clinically proven risk-benefit ratio when
its inclusion in the medical device, the notified body shall communicate to the person
expert opinion, whether this information has an impact on the established clinically
certified risk-benefit ratio when the inclusion of additional substances to the
medical device or not. Notified body shall take account of
the updated scientific opinion when reviewing its conclusion from the
the conformity assessment procedure.
8.6. A medical device shall be designed and constructed so that the
the risks posed by substances leaking from the device
reduced to a minimum. Special attention should be paid to agents
carcinogenic, mutagenic or toxic for reproduction in accordance with the law on
chemical substances.
8.7. If part of a medical device or medical
the resource as a whole, which is intended for use by the manufacturer or
disposal of medicines, body fluids or other substances to the
the body or out of the body, or a medical device designed for transport and
storage of such body fluids or other substances containing phthalates
classified as carcinogenic, mutagenic or toxic for reproduction
category 1 or 2 in accordance with the Act on chemical substances, must be accompanied by
medical device directly identified as a medical device
that contains phthalates, or must be by each of its
a piece, or, where appropriate, its sales packaging. If the intended purpose of the
This medical resource includes treatment of children, pregnant women or
women who are breastfeeding, the manufacturer must submit, for the use of such substances in the framework of the
the technical documentation of the specific statement of reasons with respect to compliance with the
essential requirements and in the instructions for use to provide information about the
residual risks for these user groups, and if possible,
also on appropriate preventive measures.
8.8. A medical device shall be designed and constructed so that the
the risk of undesirable ingress into it, having regard to the medical
the resource and the nature of the environment in which it is to be used, has been reduced to
the lowest possible rate.
9.
Infection and microbial contamination
9.1. Medical device and its manufacturing processes must be designed
so, in order to eliminate or reduce as far as possible at the lowest possible level
the risk of transmission of infection to the patient, medical device user
and other persons or contamination of the medical device listed
persons.
9.2. Tissues of animal origin used in the manufacture of medical
the resource must come from animals which had been practiced veterinary
supervision to the extent corresponding to the intended purpose of these tissues. For information about the
the geographical origin of such animals shall keep the notified body.
9.3. Processing, preservation, testing and treatment of tissues, cells and
substances of animal origin must be carried out so as to achieve the
the optimum level of safety, in particular against viruses or other contamination
the originators of the infection in the manufacture of the medical device, and that the introduction of the
validated methods for the inactivation of viruses or virus removal
or other agents of infection.
9.4. Medical device is supplied in a sterile State must be
designed, manufactured and packaged in packaging for single use, or must
be the appropriate procedures to ensure that at launch, will be sterile and
under the conditions of storage and transportation will remain sterile until
will the protective packaging is opened or damaged.
9.5. Medical device is supplied in a sterile State must be
manufactured and sterilized by an approved accordingly.
9.6. Medical device which is intended to be sterilized must be
manufactured in appropriately controlled conditions.
9.7. Packaging systems for non-sterile aluminium of a medical device must
ensure the specified level of purity of the medical device.
If the medical device is to be sterilized prior to use,
packaging systems must reduce the risk of microbiological contamination
the lowest possible rate. Packaging systems must be suitable for use
sterilization methods specified by the manufacturer.
9.8. Identical or similar to medical devices that are
sold in a sterile condition, even in non-sterile must be mutually
differentiated packaging or labelling.
10.
Construction and properties in relation to the environment
10.1. In the case that it is a medical device designed to be used in the
conjunction with another medical device, or to the relevant equipment,
thus created must be set, including the connection system, safe and
must not interfere with established performance requirements of medical
resources. Any restrictions must be indicated in the labelling
medical device or in the instructions for use.
10.2. A medical device shall be designed and constructed so that the
deleted, or at the lowest possible level of reduced risk
10.2. 1. injuries resulting from the physical properties of the medical
device, including the volume and pressure ratio, dimensional, or even
ergonomic features,
10.2. 2. associated with predictable conditions of ambient zdůvodněně
environment, in particular magnetic fields, external electrical influences,
electrostatic discharge, pressure, temperature or variations in pressure and
acceleration,
10.2. 3. interaction with other medical devices
commonly used when a specific investigations or treatment,
10.2. 4. arising from ageing of materials used or loss of
the accuracy of the measuring or control mechanism as well as from the fact
the medical device cannot maintain or calibrate (implants).
10.3. A medical device shall be designed and constructed so that the
deleted or reduced to the lowest possible level of risk of fire or
explosion during normal use and in single fault occurs. Special
attention should be paid to the medical device, which is designed
for use in an environment of inflammable substances, or substances that can
cause burning.
11.
Measuring functions
11.1. Medical device with a measuring function must be designed and
constructed so as to provide sufficient accuracy and stability in the
accuracy limits with regard to its intended purpose. The limits of accuracy provides
manufacturer.
11.2. The scale of the measuring instruments and displays shall be dealt with in accordance with the
ergonomic principles with regard to the intended purpose.
11.3. The results of the measurements carried out in a medical device with a measuring
function must be expressed in legal units under the legislation
the provisions governing metrology ^ 9).
12.
Radiation protection
12.1. A medical device shall be designed and constructed so that the
exposure of patients, users and other persons to the effects of radiation, it was with
regard to the intended purpose of the reduced to the lowest possible level, without
was limited to use of the necessary levels of radiation for diagnostic and
therapeutic purposes.
12.2. If there is a medical device designed to emit radiation in the
dangerous levels, but necessary for a specific medical
the purpose of the benefit of which is considered appropriate for this risk, you must have
staff the ability to control the level of such emissions. Such
a medical device shall be designed and constructed so that the
guaranteed reproducibility and tolerance of relevant variables
parameters.
12.3. In the case that it is a medical device designed to emit
potentially dangerous radiation, must be, where possible, provided with a
Visual or audible alerts that notify you when these emissions.
12.4. A medical device shall be designed and constructed so that the
exposure of patients, users and other persons, accidental or
scattering unwanted radiation is limited to the lowest possible level.
12.5. Manual or operating instructions for use of the medical
emitting the radiation resource must contain detailed information about the
the nature of the emitted radiation, means of protecting the user, and about
ways to prevent misuse of this radiation and the risks of exclusion
from the installation of such a device.
12.6. Medical device intended to emit ionizing radiation
must be designed and constructed so that, where this is intended,
It was possible to change and control the quantity, geometry and quality of the emitted
radiation.
12.7. Medical device emitting ionizing radiation intended for
radiodiagnostiku must be designed and constructed so that the appropriate quality
to display or output for the intended medical purpose has been made in
the smallest possible radiation load of the patient and of the user, or a third
of the person.
12.8. Medical device emitting ionizing radiation intended for
radiotherapy must be designed and constructed so that it can be reliable
monitoring and control of the delivered dose, the type and energy of radiation, volume
where necessary, as well as the quality of the radiation.
13.
Electrical safety and electromagnetic compatibility
13.1. Medical device containing electronic programmable
systems must be designed to ensure the functional stability,
the reliability and performance of these systems according to the intended
the purpose of. On the occurrence of defects in this system must be appropriately
eliminated or reduced the subsequent risk to the lowest possible level.
13.2. In the case of a medical device, which contains the program
equipment, or that is in itself a medical softwares,
the software must be validated according to the latest findings with
taking into account the principles of development lifecycle, risk management, validation
and authentication.
13.3. Medical device for which depends on patient safety
internal energy sources, must be fitted with a device allowing to determine the
the status of energy sources.
13.4. Medical device for which depends on patient safety
external energy sources, must be equipped with a warning system to
signalling the failure of this resource.
13.5. Medical device intended to monitor one or more
clinical data of a patient must be equipped with the corresponding warning
systems that will report the emergence of a situation that could lead to death
to the patient or to a serious deterioration in his State of health.
14.
14.1. A medical device shall be designed and constructed so that the
at the lowest possible level of reduced risk of electromagnetic fields,
which could impair the operation of other medical devices or
devices in their usual environment.
14.2. A medical device shall be designed and constructed so that, under
provided the proper installation and use it if possible
eliminate the risk of accidental electric shocks during normal
use on the occurrence of any faults.
14.3. A medical device shall be designed and constructed so that the
guarantee the protection of the patient, user and third parties against risks
related to mechanical properties, in particular with the strength,
stability and movement of certain parts.
14.4. A medical device shall be designed and constructed so that the
It was, taking into account the current level of science and technology and the available
options to reduce vibration at their source, reduced to the lowest possible
the risk arising from vibration induced by medical
means, unless the vibrations are part of the specific specific
the purpose of the.
14.5. A medical device shall be designed and constructed so that the
It was, taking into account the current level of science and technology and the available
to reduce noise, particularly at source, reduced to the lowest
possible hazards arising from the noise emitted by it, if this
noise is not a specific part of the intended purpose.
15.
15.1. A medical device shall be designed and constructed so that the
reduced to the lowest possible level the risks arising from the end and
the connecting parts of this medical device resources
electrical energy, pressure of the fluid, air and gas, which must
the user or the staff to handle.
15.2. A medical device shall be designed and constructed so that its
accessible parts and their surroundings, with the exception of the parts or areas intended to
supply heat or reach given temperatures, reaching for
normal operating conditions potentially dangerous temperatures.
15.3. Medical device intended to supply energy or substances
the patient must be designed and constructed so that the delivery might
be regulated with precision that ensures the safety of the patient and
the user.
15.4. Medical device intended to supply energy or substances
the patient must be equipped with a device to indicate, where appropriate,
prevents the delivery of a disproportionate amount of energy or substances that could
could be dangerous. Medical device must be equipped with appropriate
the device, which is capable of to the extent possible to avoid accidentally
the release of dangerous quantities of energy or substance from its sources.
15.5. The medical device must be clearly stated feature
controls and indicators. If the medical device
located instructions needed for its operation or indicate operating or
setting parameters via the Visual system, these must be
information understandable to the user and, where appropriate, the patient.
Information provided by the manufacturer
16.
16.1. Each device must be accompanied by the information
necessary for its safe and proper use, taking into account the
training and knowledge of the potential users, where appropriate, the operator
personnel, and to identify the manufacturer. Such information comprises
the information on the label of a medical device and in the operating instructions.
16.2. Where practicable and appropriate, the information must be in accordance with section
16.1. This annex to the medical device, the
the packaging of each piece, or on the packaging in which it is sold.
If the unit is not practicable, the packaging information must be contained in the
operating instructions supplied with one or more medical devices.
16.3. The packaging of each medical device must be accompanied by
instructions for its use; This does not apply for medical device risk
class I or IIa if the instruction manual is not needed for its safe
the use of.
16.4. If it is appropriate to ensure that the information referred to in point 16. 1. have been in
the form of the symbols used must be a symbol (marker) or identification color
comply with the harmonised standards. In the areas for which the harmonised
standards exist, the symbols and colours must be described in the documentation
supplied with a medical device.
17.
17.1. Marking medical device contains
17.1. 1. the name or business name and address of the registered office, if the
the manufacturer of a legal person; name or business name and registered office
where appropriate, the address of its principal business establishment, where appropriate, the address of the
residence, if the producer is a natural person; for medical devices
imported into the Member States of the European Union with a view to their
distribution within the European Union, the label, or the outer packaging, or instructions for
use also contain the name or business name and address
the place of business of the manufacturer's authorised representative, if
does not have a registered office in a Member State,
17.1. 2. detailed information that the user needs to
identification of the medical device and the content of the packaging,
17.1. 3. the inscription "STERILE" ("sterile"), in the case of sterile medical
resource,
17.1. 4. If necessary, the manufacturing batch number (hereinafter referred to as "the lot"),
preceded by the word ' LOT ', or the serial number,
17.1. 5. If necessary, specify the date by which it can be medical
device should be used, expressed as the year and month
17.1. 6. indicate that this is a medical device for the
single use, with information about the manufacturer, that it is a
single-use medical device, must be within the
The European Union stands United,
17.1. 7. the inscription "Individually made medical device"
in the case of individually prepared medical device
17.1. 8. the inscription "Only for clinical trials", if the medical
the device is intended for this purpose,
17.1. 9. special conditions for storage or handling,
17.1. 10. special operating instructions,
17.1. 11. the alerts, or other necessary measures,
17.1. 12. year of production, in the case of any active medical device, if the
It does not indicate the expiry date; This information may be included in
lot numbers or serial numbers, if these data easily
an inheritable,
17.1. 13. the method of sterilization of the device, if it comes
into account, and
17.1. 14. indicate that the device contains a derivative of
human blood, if it comes to such a medical device.
17.2. If you can reasonably assume that the intended purpose of medical
the resource may not be obvious to the user, the manufacturer shall indicate in the labelling
the medical device and the instructions for its use.
17.3. If it is appropriate and feasible, it must be medical
resource and its removable components, in particular data on
production lot or batch, when the specified purpose of use would be
determine the risks posed by the medical device and its
components.
17.4. Instructions for use, if this is not the nature of the medical device
out of the question, it must contain
17.4. 1. the particulars referred to in paragraph 17. 1 of this annex, with the exception of
paragraph 17.1.4. and 17. 1.5,
17.4. 2. information on the performance of a medical device in accordance with
point 3 of this annex, as well as about side effects
17.4. 3. detailed information on the characteristics of the medical device to
It was possible to determine the appropriate medical devices or equipment, the
using a secure system or a combination of, in the case of medical
resources, which, according to the intended purpose of use must be installed
or connected to other medical devices or equipment
17.4. 4. the information needed to verify whether the medical device
properly installed and can be operated correctly and safely, including
the necessary data on the nature and frequency of the maintenance and calibration
necessary to properly and safely,
17.4. 5. information about how to avert the dangers associated with
the implantation of a medical device if necessary,
17.4. 6. information regarding the risks of reciprocal influence between the
medical devices present during specific investigations or
treatment,
17.4. 7. the necessary instructions in the event of damage to the sterile packaging,
where appropriate, information on the appropriate processes in the re-sterilization,
17.4. 8. information on the appropriate processes to allow for repeated
the use of the medical device, including cleaning, disinfection,
packaging, or on the appropriate processes re-sterilisation
medical device, and recommend the number of repeated use,
If the medical device is intended for repeated use;
If the medical device is supplied with it, it has to be before
the use of sterilised must be instructions for cleaning and sterilization of such
compliance with the medical device permanently suit
General requirements; If the medical device is identified as
single-use medical device, must contain
information on known characteristics and technical factors medical
resource that producers are aware of and which could, with repeated
the use of the medical device constitute a risk; If may not be
instructions for use, this information must be available to the user on the
upon request,
17.4. 9. data on the treatment of a medical device prior to its
to use it, especially about the sterilization, final report
medical devices,
17.4. 10. data on the nature, type, intensity and distribution of the issuing
radiation for medical device emitting radiation for medical
purposes, and
17.4. 11. date of issue or the date of the last revision of the instructions for use.
17.5. Instructions for use, if this is not the nature of the medical device
excluded, must also include details that will allow
health-care professionals refer the patient on any contra-indications and
necessary preventive measures. These figures fall
17.5. 1. the measures to be taken in the event of changes in functional
the competence of the medical device,
17.5. 2. the measures to be taken under the foreseeable conditions
respect the environment, in particular with regard to the effects of the magnetic
fields, external electrical influences, electrostatic discharge, pressure or
changes in pressure, acceleration, thermal ignition sources,
17.5. 3. adequate information regarding the medicinal product or products
substances that are applied through the medical device,
including limitations in the choice of substances to be administered,
17.5. 4. the measures necessary for the safe removal of the medical
resource, in particular in case of unusual risks related with this
activities,
17.5. 5. information on medicinal substances, or human blood derivatives
contained in a medical device as an integral part of the
accordance with point 8. 5 of this annex, and
17.5. 6. information on the degree of precision required for medical
a resource with a measuring function.
Annex 2
EC declaration of conformity
The full quality assurance system
1. The manufacturer ensures the implementation and operation of the quality system approved
for the design, manufacture and final inspection of the medical device according to the
section 6 of this annex.
2. The quality system shall be subject to audit in accordance with point 7 of this annex, and shall be subject to
surveillance as specified in point 11 of this annex.
3. full quality assurance System is the procedure whereby the manufacturer who
procedure referred to in point 1 of this annex ensures and declares that the
the medical device conforms to the provisions of this regulation,
which apply to it.
4. the manufacturer affixes the CE marking medical device in accordance with §
6, draws up and maintains a written declaration of conformity.
5. Declaration of conformity applies to one or more produced
clearly marked medical devices called medical
resource, the product code of the medical device or other
a unique reference.
6.
The quality system
6.1. The manufacturer shall submit a written request to the notified person assessment
(evaluation and approval) of its quality system.
6.2. The request contains
6.2. 1. the name or business name, address of the registered office or the address of the
the main race, where appropriate, place of residence, if the producer is a natural
the person; the name or business name and address of the registered office, in the case of legal
person; in both cases, including the addresses of manufacturing sites, in which the system
the quality of the subject,
6.2. 2. all information on the medical device or category
medical devices, which are covered by the quality system,
6.2. 3. a written declaration that the notified body on the other has not been submitted
the request for the same quality system related to the same
medical device,
6.2. 4. the quality system documentation,
6.2. 5. an undertaking to proceed in accordance with the approved system
the quality,
6.2. 6. an undertaking to maintain the quality system in a usable and
efficacious, and
6.2. 7. an undertaking shall implement and update systematic
procedure to review experience gained from medical devices
placed on the market, including the clinical trial in accordance with the law on
medical devices, and in an appropriate manner to implement the necessary
corrective measures; part of this commitment, the manufacturer is notified to the Institute
adverse events according to the law on medical devices
without delay, but not later than within 15 days from the date of the finding.
6.3. The application of the quality system ensures that medical device
corresponds to the provisions of this regulation, and that at each stage of its
design to final inspection.
6.4. The elements, requirements, and measures taken by the manufacturer for it
applicable quality system must be documented in a systematic and
in the form of writing developed by the programs and procedures which are programs
quality, quality plans, quality manuals and quality records. It
includes the corresponding documentation, data and records arising from the
the procedures referred to in point 6. 5.3 of this annex.
6.5. The quality system documentation shall contain in particular an adequate description of
6.5. 1. the objectives of the quality specified by the manufacturer,
6.5. 2. the Organization of the establishment, in particular
6.5. 2.1. organisational structures, the responsibilities of executive employees
and their powers in relation to the quality of design and manufacture
medical device,
6.5. 2.2. the methods of monitoring the effectiveness of the quality system, in particular its
the ability to achieve the desired quality of design and produced
the medical device, including the inspection of the medical device, u
which has not been reached,
6.5. 2.3. where the design, manufacture and/or final inspection of the medical
the device or its parts is performed by a third party, the methods of monitoring the
the efficient operation of the quality system and in particular the manner and extent of checks
carried out by over a third party,
6.5. 3. the procedures for monitoring and verifying the design of the medical
the device, including adequate documentation, in particular
6.5. 3. the 1. a general description of the medical device, including all
variants planned, and its intended use,
6.5. 3.2. the design specifications, including the harmonised standards which are
apply the results of the risk analysis and a description of the solutions adopted to meet the
the essential requirements applicable to the medical device, if the
the harmonised standards are not applied in full,
6.5. 3.3. techniques used to control and verify the design, procedures
and systematic measures that will be used when designing the
medical device,
6.5. 3.4. If the medical device is connected to another
medical device or medical devices for the purpose of
intended, proof must be provided that it conforms to the basic
requirements when connected to any such medical device or
medical devices that have the characteristics specified by the manufacturer,
6.5. 3. the 5. a statement of whether a medical device contains as its
integral part, a substance or human blood derivative referred to in section 8.
5. Annex 1 to this regulation, and the data on the tests conducted in
this connection required to assess the safety, quality and
the usefulness of that substance or human blood derivative, taking account of the
the intended purpose of a medical device,
6.5. 3.6. a statement indicating whether it is a medical device made with
the use of tissues of animal origin referred to in Commission Regulation No 722/2012
specific requirements relating to the requirements set out in
Council directives 90/385/EEC and 93/42/EEC with respect to the active
implantable medical devices and medical devices
manufactured utilising tissues of animal origin
6.5. 3.7. the solutions adopted as referred to in part I, point 2 of Annex No.
1 to this regulation,
6.5. 3.8. the pre-clinical evaluation,
6.5. 3.9. clinical trial under the law on health care
resources,
6.5. 3.10. a proposal for labelling or instructions for use,
6.5. 4. methods of examination and quality assurance in the stage production
a medical device, in particular
6.5. 4. the 1. the methods and procedures which will be used primarily for
sterilization and the purchase and other relevant documents,
6.5. 4.2. How to identify medical device
drawn up and updated in all stages of production on the basis of
drawings, specifications or other relevant documents, and
6.5. 5. the tests and trials which will be carried out before,
during and after manufacture of the medical device, their frequency and
used test equipment; must be able to adequately backward
the calibration of the test equipment.
7.
Audit
7.1. Notified body must audit the quality system in order to
determine whether a quality system satisfies the requirements set out in section 6 of this
of the annex. Compliance with these requirements for quality systems
that use the corresponding harmonised standards.
7.2. In a team responsible for assessment of the quality system must be at least
one Member, who has experience in assessing technology
the medical device. Part of the assessment is the assessment of the dossier
the design of the relevant medical device on a representative
the basis of an inspection tour of the manufacturing processes in the cutting rooms
and manufacturer in justified cases and review of the production processes in the
the suppliers premises or other contractual partners
manufacturer.
7.3. Notified body shall notify the manufacturer, after completion of the audit
the decision, which must contain the conclusions of the inspection and the reasoned
assessment decision.
7.4. The manufacturer shall inform the person who approved the certification system
quality of plan for substantial changes to the quality system or covered with
range of medical devices. Notified body shall evaluate the proposed
changes, verify whether after these changes the quality system still complies with the
the requirements referred to in point 6 of this annex, and its decision, which must
contain the conclusions of the inspection and a reasoned assessment, it shall notify the manufacturer.
8.
Examination of the design
8.1. The manufacturer so requests, in addition to its tasks under paragraph 6 of this annex,
by the person for examination of the design dossier relating to the
a medical device that has the manufacturer intends to produce, and that
It is listed in points 6. 1. and 6. 2 of this annex.
8.2. The application contains a description of the design and manufacture of the medical device,
that has the manufacturer intends to produce, including details of its functional
eligibility. The application also contains information that will allow to assess whether
medical device complies with the requirements referred to in point 6. 5.3 of this
of the annex.
8.3. Notified body shall examine the application, and if a medical
the resource meets the requirements of this regulation, shall issue a certificate to the applicant
EC design examination. Notified body may ask for tweens
request other tests or evidence to enable it to assess the conformity of the
the medical device with the requirements of this regulation. The EC certificate of
design review must contain the conclusions of the examination, the conditions of
its validity, the data needed for identification of the approved design
medical device, where applicable, a description of its intended purpose.
9.
The drug or human blood derivative, as an integral part of the
9.1. In the case of a medical device referred to in point 8. 5.1.
Annex 1 to this regulation, shall request the notified body before the adoption of
the decision of the expert opinion by one of the competent authorities designated
the Member States, the Czech Republic, the Institute, or the Agency. If it is about
expert opinion requested by the Institute, the scientific opinion shall draw up to 210
days from the date of receipt of the complete documentation. The professional opinion of the competent
authority of the Member State or the Agency must be included in the documentation
relating to the medical device. Notified body for the adoption
the decision devotes due attention to this opinion and its
the final decision shall notify the institution that this expert opinion
has released.
9.2. In the case of a medical device referred to in point 8. 5.2.
Annex 1 to this regulation must be professional opinion of the Agency
included in the documentation concerning the device.
Notified body when adopting decision devoted to the opinion
The Agency, due attention. Notified body shall not issue a
the certificate if the Agency's scientific opinion is unfavourable.
Notified body shall inform the Agency of its final decision.
10.
Changes
10.1. Changes to the approved design that may affect the conformity with the
the essential requirements of this regulation or the conditions prescribed for the
the use of a medical device must receive further approval
certification that issued the EC design examination certificate.
The applicant shall inform by the person who issued the certificate the EC
examination of the design of all modifications to the approved design.
10.2. The additional approval of the proposal referred to in point 10. 1. this annex shall issue
notified body as a supplement to the EC design examination certificate.
11.
Supervision
11.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
11.2. The manufacturer authorizes the person to perform the necessary by the notified body
checks and provides it with the relevant information, in particular
11.2. 1. the quality system documentation,
11.2. 2. the data stipulated in the part of the quality system relating to design,
such as results of analyses, calculations, tests, the solutions adopted in part
I. section 2 of annex 1 to this regulation, pre-clinical and clinical
reviews, plan subsequent clinical tracking after placing on the market and
where appropriate, the results of subsequent clinical tracking after placing on the market, and
11.2. 3. data defined quality system for the production area
medical devices, in particular, inspection reports, test results,
data, calibration data, and reports on the qualifications of the staff concerned, etc.
11.3. Notified body performs
11.3. 1. appropriate examinations and assessment on a regular basis so as to
make sure that the manufacturer applies the approved quality system, and provides
the producers of the evaluation report, and
11.3. 2. unannounced inspection, which is entitled, in the case of
of necessity, carry out or ask for tests in order to
check that the quality system is effective, and properly carried out the inspection,
where appropriate, of the outcome of the test, if carried out, provides
manufacturers report.
12.
Retention of documents
The manufacturer of the medical device or his authorised representative
kept for at least 5 years from the date of manufacture of the medical
a resource at the disposal of the competent authorities
12.1. a declaration of conformity,
12.2. documentation of the quality system in accordance with section 6. 2. the 4. of this annex, and
in particular the documentation, data and records arising from the procedures
referred to in point 6. 5.3. of this annex,
12.3. documentation of changes in accordance with point 7. 4. of this annex,
12.4. the documentation referred to in point 8. 2. of this annex,
12.5. certificates and other documents issued by a person referred to
in points 7. 3., 8. 3., 10. 2. (a) 11. 3. of this annex.
13.
The application procedures for medical device risk class IIa or
IIB
13.1. In accordance with article 4, paragraph 2. 2 and 3 may be the procedures set out in this
Annex applied for medical device risk class IIa and
IIB. Provisions on the examination of the design of a medical device in accordance with
points 8 and 10 of this annex shall not apply in this case.
13.2. In the case of a medical device risk class IIa shall examine the
notified body as part of the assessment referred to in point 7 of this annex
the technical documentation of at least one representative sample from each
a subgroup of medical devices, as specified in point 6. 5.3. with a view to
to assess compliance with the provisions of this regulation.
13.3. In the case of a medical device risk class IIb shall examine the
notified body as part of the assessment referred to in point 7 of this annex
the technical documentation of at least one representative sample from each
a group of generic medical devices, as specified in point 6. 5.3. This
the annexes, in order to assess compliance with the provisions of this regulation.
13.4. In choosing representative sample (s) notes
notified body into account the novelty of the technology, similarities in design,
technology, manufacturing and sterilisation methods, the intended use and the results of the
of any previous relevant assessments, in particular as regards the
physical, chemical or biological properties. Notified body
shall be documented and retained for the disposal of the competent administrative authorities of the reasons
the selection of a representative sample or samples.
13.5. Further samples shall be assessed as part of the supervision of the notified body
According to section 11 of this annex.
14.
Batch release
After completing the manufacture of each batch of a medical device, which
contains, as an integral part, a substance, which can be
used alone, considered to be a medicinal product constituent or a medicinal product
product derived from human blood or human plasma, in the case that
its action is only an additional effect to the effect
medical device, the manufacturer shall inform the person of the certification
batch release of these medical devices and shall forward to it the certificate
concerning the release of the batch of human blood derivative used in this
medical device, issued by the competent laboratories designated for this
the purpose by the Member State, in the Czech Republic in accordance with the law on
pharmaceuticals.
Annex 3
EC type-examination
1.
Medical device type-examination is the procedure whereby the
notified body finds that a representative sample of assessed
manufacture of the medical device (hereafter named the type) satisfies the relevant
the provisions of this regulation that apply to it. In connection with the
the manufacturer ensures and declares that the medical devices supplied
on the market correspond to the certified type.
2.
Procedure the manufacturer
2.1. The manufacturer, or authorised representative so requests by
a person of the type-examination of the medical device.
2.2. The request contains
2.2. 1. the name or business name and the address or registered office address
the main business establishment, where appropriate, place of residence, if the manufacturer
is a natural person; the name or business name and address of the registered office, in the case of
the legal entity,
2.2. 2. the name and address of the authorised representative if the
a natural person; business name or the name and address of the registered office, in the case of
legal person
2.2. 3. the documentation referred to in point 2. 3. of this annex, which is
needed to assess the conformity with the requirements of this regulation; the applicant
pass the type of the notified person may request further samples, and
2.2. 4. a written declaration that the same application has not been lodged other
the notified person.
2.3. The documentation must be processed so as to enable an understanding of the
the design, manufacture and performances of the medical device and must
contain
2.3. 1. General description of the type, including any variants planned, and its
intended use,
2.3. 2. design drawings, manufacturing technology estimated,
in particular as regards sterilization, and diagrams of components, sub-assemblies and
circuits,
2.3. 3. the descriptions and explanations necessary for the understanding of the drawings and schemes
the functioning of the medical device,
2.3. 4. a list of the harmonised standards which have been fully or partially
used and a description of the solutions adopted to meet the essential requirements,
where the harmonised standards are not applied in full,
2.3. 5. results of the design calculations, risk analysis,
research, technical tests,
2.3. 6. a statement that the medical device contains as its
integral part, a substance or human blood derivative referred to in section 8.
5. Annex 1 to this regulation, and the data on the tests conducted in
this connection required to assess the safety, quality and
the usefulness of that substance or human blood derivative, taking account of the
the intended purpose of a medical device,
2.3. 7. a statement that the medical device is manufactured using
tissues of animal origin referred to in Commission Regulation on special requirements
related to the requirements laid down in Council directives 90/385/EEC and
93/42/EEC with respect to active implantable medical devices and
medical devices manufactured utilising tissues of animal origin
2.3. 8. the solutions adopted according to part I, point 2 of annex 1 to this
Regulation,
2.3. 9. the pre-clinical evaluation,
2.3. 10. a clinical trial according to the law on medical devices
and
2.3. 11. the proposal for the designation, where appropriate, instructions for use.
3.
How to obtain
3. the 1. Notified body shall examine and assess the documentation and verify that the
the type has been manufactured in accordance with that documentation. Notified body
captures all the components that are designed in accordance with
relevant harmonised standards, as well as those which, according to
the following harmonised standards are designed.
3.2. Notified body shall carry out or have carried out inspections and tests
necessary to verify whether the solutions adopted by the manufacturer meet the essential
the requirements under this regulation, where the harmonised standards are not
used. If the intended purpose is to be a health
resource associated with another medical device, or other
medical devices, it must be demonstrated that, in connection with such
a medical device or medical devices with
the characteristics specified by the manufacturer, the system, or a combination
as all the basic requirements.
3.3. Notified body shall carry out or have carried out appropriate checks
or the tests necessary to verify whether the manufacturer has chosen to apply the
harmonised standards, these have actually been applied.
3.4. Notified body agree with the applicant the location where the necessary
the examinations and tests carried out.
4.
The conditions for release of documents certification
4. the 1. If the type satisfies the provisions of this regulation, the
notified body EC type-examination certificate to the applicant. To
type-examination certificate shall be accompanied by the corresponding part of
documentation, the notified body shall keep a copy of the 1.
4.2. EC type-examination certificate contains
4.2. 1. the name or business name and the address or registered office address
the main business establishment, where appropriate, place of residence, if the manufacturer
is a natural person; the name or business name and address of the registered office, in the case of
the legal entity,
4.2. 2. the conclusions of the examination, conditions for its validity and the data
necessary to identify the approved type.
4.3. In the case of a medical device referred to in point 8. 5.2.
Annex 1 to this regulation, shall request the notified body before the adoption of
the decision of the expert opinion by one of the competent authorities designated
the Member States, the Czech Republic, the Institute, or the Agency. If it is about
expert opinion requested by the Institute, the scientific opinion shall draw up to 210
days from the date of receipt of the complete documentation. The professional opinion of the institution or
The Agency must be included in the documentation concerning the medical
resource. Notified body when adopting decision devoted to this
the opinion of the appropriate attention and its final decision to
body of this expert opinion.
4.4. In the case of a medical device referred to in point 8. 5.3.
Annex 1 to this regulation must be professional opinion of the Agency
included in the documentation concerning the device.
Notified body when adopting decision devoted to the opinion
The Agency, due attention. Notified body shall not issue a
the certificate if the Agency's scientific opinion is unfavourable.
Notified body shall inform the Agency of its final decision.
5.
Changes
5.1. The manufacturer, or the authorised representative shall inform the certification body
the person who issued the EC type-examination certificate of any
significant change made to the approved medical device.
5.2. Changes to the approved product must receive further
approval of certification that issued the EC type-examination certificate
where such changes may affect the conformity with the essential requirements
or with the conditions prescribed for use of the medical device.
Additional approval has the form of a supplement to the initial EC certificate
type-examination.
6.
The transmission and retention of documents
6.1. Other notified the person may obtain a copy of the certificate
type-examination, where applicable, their additions. Annex the following certificates
must be available to the other notified parties on the basis of a reasoned
request the prior informing the manufacturer.
6.2. The manufacturer or his authorized representative shall keep with the
the technical documentation copies of type-examination certificates and their
additions for a period of at least 5 years from the date of manufacture of the medical
resource.
Annex 4
EC verification
1.
Verification is the procedure whereby the manufacturer or his authorised representative
ensures and declares that the medical device which was
tested by the person corresponds to the type described in the certificate
the type-examination and satisfies the requirements of this regulation, the
apply.
2.
Procedure the manufacturer
2.1. Manufacturer shall carry out the necessary measures to ensure that the manufacturing
process produces medical devices corresponding to the type referred to in
type-examination certificate and satisfies the requirements of this regulation,
which apply to it.
2.2. The manufacturer prepares the documentation before you start the production
characterizing the
2.2. 1. the manufacturing process, in particular as regards sterilization, if it is
It must,
2.2. 2. the routine, pre-established provisions to be
introduced to ensure the homogeneity of the production, and
2.2. 3. where appropriate, the conformity of the medical device with the type
as described in the type-examination certificate and with the requirements that apply to
subject to this regulation.
2.3. The manufacturer or his authorised representative shall affix the CE marking and
draw up a written declaration of conformity.
2. the 4. The manufacturer ensures and maintains sterility in the manufacture of medical
resource placed on the market in a sterile State, for this purpose, proceed
In addition to the above, and pursuant to sections 2 to 4 of annex 5 to this
of the regulation.
2.5. The manufacturer shall undertake to Institute and keep updated a systematic
procedure to review experience gained from medical devices
placed on the market, including the clinical trial in accordance with the law on
medical devices. Part of this commitment, the manufacturer is
to report adverse events to the Institute, and it promptly, but not later than
15 days from the date of their findings and further and appropriate way to implement
the necessary corrective measures.
3.
How to obtain
3. the 1. Notified body performs the corresponding appropriate examinations and
tests in order to check the conformity of the medical device with the requirements of
This regulation in accordance with the decision of the manufacturer
3. the 1. 1. by checking and testing of each medical device according to the
point 4 of this annex, or
3. the 1. 2. by checking and testing of medical devices on the basis of
statistical methods as specified in point 5 of this annex.
3.2. Such checks shall not apply to components of the production process,
that apply to ensure sterility.
4.
Verification by examination and testing of each piece
4. the 1. Notified testing of every medical device
individually, in order to verify the conformity of each medical device
with the type described in the type-examination certificate and with the requirements of this
the regulation, which is applicable to it. Notified body performs
the appropriate tests as set out in the relevant harmonised standard, and in
If necessary, performs the equivalent of the test.
4.2. Notified body shall affix or cause to be placed on each approved
medical device your identification number and with reference to the
tests carried out shall draw up a written certificate of conformity of each
the medical device with the type-examination certificate as referred to in
type, and with the requirements stemming from this regulation.
5.
Statistical verification
5.1. The manufacturer shall submit to the medical devices manufactured in homogeneous
the batches.
5.2. Notified body removes from each batch of a randomly selected sample,
individual medical devices from this sample examines individually,
with the procedure referred to in point 4 of this annex, or individual
medical devices shall be subjected to an equivalent tests to assess the
the conformity of medical devices with the type as described in the certificate of
type-examination and with the requirements of this regulation, the
apply, for the purpose of determining whether the batch is to be approved, or
disapproved.
5.3. Statistical verification juxtaposition, or medical devices
the measurement uses sampling plans with the operational characteristics of which
ensure a high level of safety and performance according to the
the latest knowledge of science and technology. Sampling plans are set out
accordance with harmonised standards, taking into account the nature of the groups
medical devices.
5.4. If the notified body shall approve the batch, place or leave
place it on any medical device your identification number and
shall draw up a written certificate of conformity with reference to the tests carried out.
All medical devices in the batch may be placed on the market with
the exception of medical devices in the selected sample that were
found to be unsatisfactory.
5.5. If the notified body the lot does not approve, shall take measures to
avoid putting such a lot on the market.
5.6. Notified body may suspend the statistical verification, the
case of frequent failure to approve batches.
5.7. The manufacturer may place the device identification
the number of the notified body to its liability in the course of the
process.
6.
Retention of documents
The manufacturer of the medical device or his authorised representative
kept for at least 5 years from the date of manufacture of the medical
resource for the disposal of the competent administrative authorities
6.1. Declaration of conformity,
6.2. the documentation referred to in point 2 of this annex,
6.3. the certificates referred to in points 4. 2. and 5. 4. of this annex,
where appropriate, the
6.4. EC type-examination certificate referred to in annex 3 to this
of the regulation.
7.
The application procedures for medical device risk class IIa
In accordance with article 4, paragraph 2. 2 may be the procedures set out in this annex
applied in medical device risk class IIa with the fact that
by way of derogation
7.1. from points 1 and 2. 1. up to 2. 4. this annex on the basis of
Declaration of conformity the manufacturer ensures and declares that the medical
resource risk class IIa is made in accordance with the technical
documentation referred to in point 2 of annex 7 to this regulation and meets the
the requirements of this regulation, which is applicable to it, and
7.2. from points 1, 2. 1. up to 2. 4., and points 4 and 5 of this annex,
verification carried out by the person intended to confirm the conformity of the
medical device risk class IIa with the technical documentation
referred to in point 2 of annex 7 to this regulation.
8.
Batch release
In case of verification referred to in point 4 of this annex, upon completion of the production
each lot of a medical device that has as its
integral part, a substance, which can be used separately
considered to be a medicinal product constituent or a medicinal product
derived from human blood or human plasma, in the case that its
the action represents the only additional effect to the effect of the medical
resource, and in the case of verification referred to in point 5 of this annex, the manufacturer
by the notified body shall inform the person about the release of this batch of medical
resource and shall forward to it the official certificate concerning the release of the batch
human blood derivative used in the device issued by a
appropriate laboratory designated for this purpose by the Member State, in the United
Republic, in accordance with the law on pharmaceuticals.
Annex 5
EC declaration of conformity
Production-quality assurance
1.
1.1. The manufacturer ensures the implementation and operation of the quality system
approved for the manufacture and final inspection of the relevant medical
the means referred to in point 2 of this annex. The quality system shall be subject to audit
referred to in point 3 and to the surveillance as specified in point 4 of this annex.
1.2. The production quality is part of the security procedure by which the manufacturer,
acting in accordance with point 1. 1. ensures and declares that the
medical device corresponds to the type described in the certificate of
type-examination and splňujě requirements of this regulation, the
apply.
1.3. The manufacturer affixes the CE marking medical device in accordance with the
§ 6, draws up and maintains a written declaration of conformity.
1.4. The Declaration of conformity shall be drawn up for one or more produced
clearly marked medical devices called medical
the resource code, medical device or other unique
by reference.
2.
The quality system
2.1. The manufacturer shall submit a written request to the notified person about his
the quality system.
2.2. The request contains
2.2. 1. the name or business name and address of the registered office or the address of the
the main business establishment, where appropriate, place of residence, if the manufacturer
is a natural person; the name or business name and address of the registered office, in the case of
the legal person; in both cases, including the addresses of manufacturing sites
which are covered by the quality system,
2.2. 2. all relevant information on the medical device or the
the category of medical devices, on which the quality system applies,
2.2. 3. a written declaration that the notified body on the other has not been submitted
the request for the same quality system related to the same
medical device,
2.2. 4. the quality system documentation,
2.2. 5. an undertaking to proceed in accordance with the approved system
the quality,
2.2. 6. an undertaking to maintain the quality system in a usable and
efficacious,
2.2. 7. where appropriate, the technical documentation of the approved type
medical device and a copy of the type-examination certificate and
2.2. 8. an undertaking shall implement and update systematic
procedure to review experience gained from medical devices
placed on the market, including the clinical trial in accordance with the law on
medical devices; part of this commitment, the manufacturer is
to report adverse events to the Institute, and it promptly, but not later than
15 days from the date of their findings and further and appropriate way to implement
the necessary corrective measures.
2.3. The application of the quality system ensures that medical device
corresponds to the type described in the type examination certificate.
2. the 4. Requirements and measures used by the manufacturer for the system
quality must be systematically and duly documented in writing
established policies and practices. This quality system documentation
must allow the uniform interpretation of the concept of quality of medical devices
and procedures, in particular the quality programmes, plans, manuals and quality
quality records.
2.5. The quality system documentation contains a description of
2.5. 1. the objectives of the quality specified by the manufacturer,
2.5. 2. the Organization of the establishment, especially
2.5. 2.1. organisational structures, the responsibilities of executive employees
and their powers in relation to the manufacture of medical devices,
2.5. 2.2. the methods of monitoring the efficient operation of the quality system and in particular
its ability to achieve the desired quality of the medical device,
including control of medical devices that the required quality
below,
2.5. 2.3. the methods of monitoring the efficient operation of the quality system, and
in particular, the manner and extent of the checks carried out by over a third party, if
a third person conducts production or final inspection and testing
medical devices or their parts,
2.5. 3. techniques of checks and quality assurance of medical devices
in the stage of their production, in particular
2.5. 3. the 1. procedures that will be used, particularly as regards the
sterilization, the sale and the relevant documents,
2.5. 3.2. procedures for the identification of medical devices
developed and updated to all stages of production on the basis of drawings,
specifications and other relevant documents, and
2.5. 4. the appropriate tests and trials which will be carried out before,
during and after the production of medical devices, their frequency and
used test equipment; must be able to adequately backward
the calibration of the test equipment.
3.
Audit
3. the 1. Notified body must audit the quality system in order to
determine whether a quality system satisfies the requirements set out in paragraph 2. 3.
of this annex. Compliance with these requirements shall be presumed for systems
quality, for which the corresponding harmonised standards are used.
3.2. In a team responsible for assessment of the quality system must be at least
one member with experience of assessing the relevant technologies.
Evaluation procedure includes a tour of the premises of the manufacturer, and in
duly substantiated cases, control of the production processes in the operating
areas, or its suppliers, the manufacturer of the other Contracting Parties.
3.3. Notified body shall notify the manufacturer, after completion of the audit system
quality, its result, which must contain the conclusions of the inspection and
a reasoned assessment.
3.4. The manufacturer shall inform the person who approved the certification system
quality of plan for substantial changes to the quality system or covered with
range of medical devices. Notified body shall evaluate the proposed
changes, verify whether after these changes the quality system still complies with the
the requirements referred to in point 2. 3. of this annex and its decision, which
must contain the conclusions of the inspection and a reasoned assessment, it shall notify the manufacturer.
4.
Supervision
4. the 1. The aim of surveillance is to ensure that the manufacturer duly fulfils the requirements
arising out of the approved quality system.
4.2. The manufacturer authorizes the person to perform the necessary by the notified body
checks and provides it with the relevant information, in particular
4.2. 1. the quality system documentation,
4.2. 2. the technical documentation,
4.2. 3. data defined quality system for the production area
medical devices, especially the inspection report, the results of
and test data, calibration data, and reports on the qualifications of the relevant
employees.
4.3. Notified body performs
4.3. 1. appropriate examinations and assessment periodically, so that the
make sure that the manufacturer applies the approved quality system, and provides a
inspection and assessment report
4.3. 2. at its discretion, well in advance of unannounced checks
in which, if necessary, carry out or have carried out tests for
to check that the quality system is effective, and properly made
control and of the outcome of the test, if carried out, provides
manufacturers of a written report.
5.
Retention of documents
The manufacturer of the medical device or his authorised representative
at the disposal of the competent administrative authorities for a period of at least 5 years
from the date of manufacture of the medical device
5.1. Declaration of conformity,
5.2. the quality system documentation,
5.3. changes in accordance with point 3. 4. of this annex,
5.4. the technical documentation of the approved type and a copy of the certificate of
type-examination,
5.5. the decisions and reports of the notified body referred to in points 3. 4. and 4. 3.
of this annex,
5.6. where appropriate, EC type-examination certificate referred to in annex 3 to the
application of this regulation.
6.
The application procedures for medical device risk class IIa
6.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this
Annex applied for medical device risk class IIa with
by way of derogation from points 1. 2. up to 1. 4. in paragraph 2 of this annex for the
the basis of the Declaration of conformity the manufacturer ensures and declares that the
medical device risk class IIa are manufactured in accordance with
the technical documentation referred to in point 2 of annex 7 to this regulation, and
meets the requirements of this regulation which apply to it.
6.2. In the case of a medical device risk class IIa shall examine the
notified body as part of the assessment referred to in point 3. 1. up to 3. 3.
of this annex, the technical documentation referred to in point 2 of annex 7 to this
Regulation of at least 1 representative sample from each subgroup
medical devices in order to assess compliance with the provisions of this
of the regulation.
6.3. In choosing representative sample (s) notes the notified
the person in the account of the novelty of the technology, similarities in design, technology,
manufacturing and sterilisation methods, the intended use and the results of all
previous related reviews, in particular as regards the physical,
chemical and biological properties, which was carried out in accordance with the
This regulation. Notified body shall document and must, for
the competent administrative authority reasons for choosing representative sample
samples.
6.4. Further samples shall be assessed as part of the supervision of the notified body
According to paragraph 4. 3.2. of this annex.
7.
Batch release
After completing the manufacture of each batch of a medical device, which
contains, as an integral part, a substance, which can be
used alone, considered to be a medicinal product constituent or a medicinal product
product derived from human blood or human plasma, in the case that
its action is only an additional effect to the effect
medical device, the manufacturer shall inform the person of the certification
the release of this batch of medical device and shall forward to it official
certificate concerning the release of the batch of human blood derivative used
in the medical device issued by the competent laboratory designated for
this purpose by the Member State, in the Czech Republic in accordance with the law on
pharmaceuticals.
Annex 6
EC declaration of conformity
Quality assurance of medical device
1.
1.1. The manufacturer ensures the implementation and operation of the quality system
approved for the final inspection and testing by a competent medical
resource under points 2 and 3 of this annex and shall be subject to surveillance as specified in point 4
of this annex.
1.2. In the case of a medical device marketed in a sterile
the State claims the manufacturer points 2 to 4 of annex 5 to this
Regulation, and only for the properties of the process intended for
secure and maintain sterility.
1.3. Medical device quality assurance is part of the procedure,
which the manufacturer, who shall proceed in accordance with point 1. 1. this annex provides
and declares that the medical device conforms to the type
as described in the type-examination certificate and satisfies the requirements of this
the regulation, which is applicable to it.
1.4. The manufacturer affixes the CE marking medical device in accordance with the
§ 6, where the CE marking is accompanied by the identification number of the notified
the person who is involved in the conformity assessment, draws up and maintains
written declaration of conformity.
1.5. The Declaration of conformity shall be drawn up for one or more produced
clearly marked medical devices called medical
the resource code, medical device or other unique
by reference.
2.
The quality system
2.1. The manufacturer shall submit a written request to the notified person assessment
evaluation and approval of their quality system.
2.2. The request contains
2.2. 1. the name or business name and the address or registered office address
the main business establishment, where appropriate, place of residence, if the manufacturer
is a natural person; the name or business name and address of the registered office, in the case of
the legal entity,
2.2. 2. the required information on the medical device or category
medical devices, which are covered by the quality system,
2.2. 3. a written declaration that the notified body on the other has not been submitted
application for assessment of his quality system for the same medical device
2.2. 4. the quality system documentation,
2.2. 5. an undertaking to proceed in accordance with the approved system
the quality,
2.2. 6. an undertaking to maintain the approved quality system in
applicable and efficacious,
2.2. 7. where appropriate, the technical documentation of the approved type and
a copy of the type-examination certificate,
2.2. 8. an undertaking shall implement and update systematic
procedure to review experience gained from medical devices
placed on the market, including the clinical trial in accordance with the law on
medical devices; part of this commitment, the manufacturer is
to report adverse events to the Institute, and it promptly, but not later than
15 days from the date of their findings and further and appropriate way to implement
the necessary corrective measures.
2.3. The manufacturer's quality system in the framework of this
2.3. 1. examine any medical device or a representative
a sample from each batch,
2.3. 2. carry out the appropriate tests as set out in the corresponding
harmonised standard, or equivalent tests, to make sure that the
medical device corresponds to the type described in the certificate of
type-examination certificate and satisfies the requirements laid down in this regulation that apply to
it, and
2.3. 3. systematically and properly documents all the
the elements, requirements and provisions, in the form of written measures, procedures
and instructions.
2. the 4. The documentation must allow uniform interpretation of the quality plan program
quality manuals and quality records.
2.5. The documentation contains adequate description
2.5. 1. the objectives of the quality specified by the manufacturer,
2.5. 2. organizational structures, responsibilities and powers of the managerial
staff in terms of production quality,
2.5. 3. the examination and testing of the medical device when the
manufacture; must be able to adequately trace the accuracy of
the calibration of the test equipment,
2.5. 4. the methods of monitoring the effectiveness of the quality system,
2.5. 5. quality records, primarily of the inspection reports, reports of the
test and calibration and the qualifications of the staff concerned, and
2.5. 6. where the production and/or final inspection and testing of the medical
the device or its parts is performed by a third party, the methods of monitoring the
the effective operation of the quality system, and the type and range checks
carried out by over a third party.
2.6. The checks referred to in point 2. 5.6. This annex shall not apply to the part of the
the manufacturing process designed to secure sterility.
3.
Audit
3. the 1. Notified body must audit the quality system to the manufacturer with the
to determine if the system satisfies the requirements laid down in points 2. 3. up to
2.6. of this annex. Compliance with these requirements shall be presumed for systems
quality, in which the use of harmonized standards.
3.2. In a team responsible for assessment of the quality system must be at least
one Member, who has experience with the assessment of the relevant technologies.
Evaluation procedure includes a check of the premises of the manufacturer, and in
duly substantiated cases, control of the production processes in the operating
vendor spaces of the manufacturer.
3.3. Notified body shall notify the manufacturer, after completion of the audit system
the quality of the result, which must contain the conclusions of the inspection and
a reasoned assessment.
3.4. The manufacturer shall inform the person who approved the certification system
the quality, of the intention to significantly change this system. Notified body
shall evaluate the changes proposed and verify whether after these changes the quality system
still complies with the requirements referred to in points 2. 3. up to 2. 6. of this annex
and shall notify the manufacturer of its decision to the manufacturer that must contain the conclusions
the inspection and a reasoned assessment.
4.
Supervision
4. the 1. The aim of surveillance is to ensure that the manufacturer duly fulfils the requirements
arising out of the approved quality system.
4.2. The manufacturer allows the notified person access to control,
testing and storage spaces that are used in the manufacture of
medical device, and provides the appropriate person notified
information, in particular
4.2. 1. the quality system documentation,
4.2. 2. the technical documentation, and
4.2. 3. data defined quality system for the production area
medical devices, especially the inspection report, the results of
and test data, calibration data, and reports on the qualifications of the relevant
employees.
4.3. Notified body performs
4.3. 1. appropriate examinations and assessment periodically, so that the
make sure that the manufacturer applies the approved quality system, and provides a
inspection and assessment report
4.3. 2. at its discretion, well in advance of unannounced checks
in which, if necessary, carry out or have carried out tests for
to check that the quality system is effective and properly manufacture
the medical device conforms to the requirements of this regulation.
4.4. During the checks referred to in point 4. 3.2. of this annex, shall be verified
an adequate sample of medical devices manufactured for the removed
manufacturer certification, and appropriate tests shall be carried out according to the
the relevant harmonized standards or shall be equivalent to
of the test. If one or more of the samples do not match, the
notified the appropriate measures. Notified body shall provide the
the manufacturer with a visit report and, if tests have been carried out and the test
the message.
5.
Retention of documents
The manufacturer of the medical device or his authorised representative
at the disposal of the competent administrative authorities for a period of at least 5 years
from the date of manufacture of the medical device
5.1. Declaration of conformity,
5.2. the documentation referred to in point 2. 2. the 4. of this annex,
5.3. changes in accordance with point 3. 4. of this annex,
5.4. the decisions and reports of the notified body referred to in points 3. 4., 4. 3.
4.4. of this annex,
5.5. where appropriate, the certificate of conformity referred to in annex 3 to this regulation.
6.
The application procedures for medical device risk class IIa
6.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this
Annex applied for medical device risk class IIa with
by way of derogation from points 1. 3. up to 1. 5. (a) 2 of this annex on the basis of
Declaration of conformity the manufacturer ensures and declares that the medical
resource risk class IIa is made in accordance with the technical
documentation referred to in point 2 of annex 7 to this regulation and complies with the
the requirements of this regulation which apply to it.
6.2. In the case of a medical device risk class IIa shall examine the
notified body as part of the assessment referred to in point 3. 1. up to 3. 3.
of this annex, the technical documentation referred to in point 2 of annex 7 to this
Regulation of at least one representative sample from each subgroup
medical devices in order to assess compliance with this regulation.
6.3. In choosing representative sample (s) notes the notified
the person in the account of the novelty of the technology, similarities in design, technology,
manufacturing and sterilisation methods, the intended use and the results of all
previous related reviews, in particular as regards the physical,
chemical and biological properties, which was carried out in accordance with the
This regulation. Notified body shall document and must, for
the competent administrative authority reasons for choosing representative sample
samples.
6.4. Further samples shall be assessed as part of the supervision of the notified body
According to paragraph 4. 3. the 1. of this annex.
Annex 7
EC declaration of conformity
The basic conformity assessment
1.
Basic assessment of conformity is the procedure whereby the manufacturer or his
authorised representative, who shall proceed in accordance with section 2 of this annex, and in
the case of the medical device placed on the market in a sterile condition
or a medical device with a measuring function shall proceed in accordance with point 4
of this annex ensures and declares that the medical
the resource meets the requirements of this regulation which apply to it.
2.
The technical documentation
2.1. The manufacturer shall establish the technical documentation must enable the
assessment of the conformity of the medical device with the requirements of this regulation.
2.2. Technical documentation shall contain, in particular,
2.2. 1. General description of the medical device, including all
variants planned, and its intended purpose,
2.2. 2. design drawings, manufacturing technology and
schemas, subassemblies, or circuits,
2.2. 3. the descriptions and explanations necessary for the understanding of the above
drawings, diagrams and the function of the medical device,
2.2. 4. the results of the risk analysis and a list of the harmonised standards
used in full or in part, and descriptions of the solutions approved for
meet the essential requirements where the harmonised standards are not applied
in its entirety,
2.2. 5. in the case of a medical device marketed in the
sterile condition, description of the methods used and the validation report,
2.2. 6. the results of the design calculations and of the inspections carried out; If
to meet the intended purpose of the device is to be combined with other
medical device, where appropriate, with other health
resources, it must be demonstrated that the medical device meets the
the basic requirements in connection with the medical device or
other medical devices that have properties specified
by the manufacturer,
2.2. 7. the solutions adopted according to part I, point 2 of annex 1 to this
Regulation,
2.2. 8. preclinical evaluation,
2.2. 9. a clinical trial according to the law on medical devices,
2.2. 10. medical device labeling and instructions for its use in
the Czech language.
2.3. The manufacturer of the medical device or his authorised representative
must for at least 5 years from the date of manufacture of the medical
resource to keep at the disposal of the competent authorities, the technical
documentation and the latest version of the written declaration of conformity.
3.
Obligation after the placing on the market
The manufacturer shall establish and update a systematic procedure to review
the experience gained from medical devices placed on the market,
including the clinical trial in accordance with the law on health care
resources. Part of this commitment, the manufacturer is notified to the Institute
adverse events, and it promptly, but not later than within 15 days from the date of
their findings, and on and in an appropriate manner to implement the necessary corrective
measures.
4.
Application of the procedures for sterile medical device and
medical device with measuring functions
4. the 1. For medical device placed on the market in a sterile State and
for medical device risk class I with measuring function, the manufacturer
adheres to in addition to the provisions of this annex as well as one of the procedures referred to in annex
2, 4, 5 or 6 to this regulation.
4.2. Application of the procedures and measures of the notified body referred to in no attachments.
2, 4, 5 or 6 to this Regulation shall be confined in a medical device
4.2. 1. put on the market in sterile condition, only the aspects of production,
touching the provisioning and maintaining sterile conditions,
4.2. 2. with a measuring function, only the aspects of production, which are related to the
This happens to be a medical device with the metrological requirements
and you can apply the provisions of point 5 of this annex.
5.
The application procedures for medical device risk class IIa
5.1. In accordance with article 4, paragraph 2. 2 may be the procedures set out in this
Annex applied for medical device risk class IIa with
by using this annex in connection with the procedure according to annexes 4,
5 or 6 to this Regulation shall be the Declaration of conformity pursuant to those
attachments to a single declaration of conformity.
5.2. In the Declaration of conformity is drawn up pursuant to this annex,
the manufacturer ensures and declares that the medical device design
meets the requirements of this regulation which apply to it.
Annex 8
Statement on medical devices for special purposes
1.
Declaration of individually made medical device
1.1. The manufacturer or his authorised representative shall draw up on individually
medical device made a statement.
1.2. The Declaration contains
1.2. 1. the name or business name and the address or registered office address
the main business establishment, where appropriate, place of residence, if the manufacturer
is a natural person; the name or business name and address of the registered office, in the case of
the legal entity,
1.2. 2. the data allowing identification of the medical
resource,
1.2. 3. a statement that the medical device is designed exclusively
for a particular user, together with an indication of his name and surname,
1.2. 4. name of medical practitioner or other authorized person, that issued the
a prescription to this medical device and the name or business
name and address of the provider of health care services,
1.2. 5. specific properties of medical device, as they are
listed in the medical prescription,
1.2. 6. a statement that the medical device meets the
the basic requirements, where necessary, details of which of these fundamental
requirements are not fully met, including in the preamble.
1.3. The manufacturer of a medical device made of individually leads and
exposes the relevant administrative authorities individually documentation
made of medical device and makes the necessary arrangements to
ensure that from its production process is based on an individually prepared
a medical device in accordance with that documentation.
1.4. The documentation referred to in point 1. 3. this annex contains the
1.4. 1. the place or places of production,
1.4. 2. information that allows to understand the design, manufacture and performance
the eligibility of a medical device, in order to assess the conformity with the
the requirements of this regulation.
1.5. The manufacturer shall take all necessary measures to ensure that the manufacturing process
ensures compliance of the manufactured medical device documentation
in accordance with point 1. 4 of this annex.
1. the 6. Manufacturer evaluates and documents the experience gained with the
individually-crafted medical devices after their transmission
the patient to use, including the evaluation of information relating to the
clinical trial according to the law on medical devices.
Part of this commitment, the manufacturer is notified to the Institute of adverse events,
and it shall, without delay, but not later than within 15 days from the date of their findings and
Furthermore, an appropriate way to implement the necessary corrective measures.
2.
Statement of medical device intended for clinical investigation
2.1. The manufacturer or his authorised representative shall draw up on healthcare
a resource intended for clinical investigations the statement.
2.2. The Declaration contains
2.2. 1. the data allowing identification of the medical
resource,
2.2. 2. the clinical investigation plan,
2.2. 3. the investigator's brochure,
2.2. 4. the confirmation of insurance of subjects,
2.2. 5. the documents used to obtain informed consent,
2.2. 6. a statement that the device incorporates, as an integral
part, a substance or human blood derivative referred to in section 8. 5. annexes
# 1,
2.2. 7. a statement whether the device is manufactured utilising tissues of
of animal origin as referred to in section 4 of this regulation,
2.2. 8. the opinion of the Ethics Committee and the details of the
aspects, which are covered by this opinion,
2.2. 9. the name of the medical practitioner or other authorized person and of the institution responsible for
clinical trials,
2.2. 10. the place, starting date and scheduled duration of clinical trials,
2.2. 11. a statement that the device complies with the essential requirements
In addition to the aspects, which are the subject of clinical trials, and with a view
on this point of view has taken all the precautionary measures for the protection of
the health and safety of the patient.
2.3. The manufacturer makes the relevant administrative authorities with documentation
medical device intended for clinical investigation.
2. the 4. The documentation of the medical device intended for clinical
the test described in point 2.3. contains
2. the 4. 1. a general description of the medical device and its intended purpose,
2. the 4. 2. design drawings, manufacturing technology estimated,
in particular as regards sterilization, and diagrams of components, sub-assemblies and
circuits,
2. the 4. 3. the descriptions and explanations necessary for the understanding of said drawings and
schemes and the operation of the medical device,
2. the 4. 4. the results of the risk analysis and a list of the harmonised standards
were used wholly or in part, and descriptions of the solutions adopted to meet the
the essential requirements of this regulation, if not used
harmonised standards,
2. the 4. 5. If a medical device incorporates, as an integral
part, a substance or human blood derivative referred to in section 8. 5. annexes
No 1 to this regulation, the data on the tests conducted in this
connection required to assess the safety, quality and usefulness of
of that substance or human blood derivative, taking account of the intended purpose of the
medical device,
2. the 4. 6. If a medical device is manufactured utilising tissues of
animal origin referred to in paragraph 4, the risk management measures in this
the context that was applied in order to reduce the risk of transmission
the disease,
2. the 4. 7. the results of the design calculations, checks,
technical tests.
2.5. The manufacturer shall take all measures necessary to ensure that
the result of the production process was a medical device which corresponds to the
the documentation referred to in point 2. 4.
2.6. The manufacturer shall permit an assessment or audit of the effectiveness of these
measures.
3.
Documentation and declarations referred to in this annex shall be kept for a period of
at least 5 years and in the case of implantable devices at least 15
years of age.
Annex 9
The classification rules
(I).
Basic concepts
1.
For the purposes of this annex, means the
1.1. temporary duration of continuous use of the medical device
After a period of less than 60 minutes,
1.2. the short duration of continuous use of the medical device
for less than 30 days,
1.3. the long-term duration of continuous use of the medical device
For more than 30 days,
1.4. body hole natural opening in the body, including the external surface
the eyeball or permanent, artificially created opening,
1.5. invasive medical device medical device
that completely or in part, penetrates inside the body through a body orifice or the surface
of the body,
1. the 6. invasive medical device surgically invasive
medical device which penetrates inside the body using his surface
surgical intervention or in connection with the
1.7. implantable medical device medical device
to be totally introduced into the human body or to replace
the epithelial surface or the surface of the eye surgery, after which the
remain in place; for implantable medical device is also
a medical device shall be deemed to be the surgical procedure
partially introduced into the human body, and after the procedure there remain at least 30
days,
1.8. a surgical instrument for the repeated use of a tool designed to
surgical use by cutting, drilling, sawing, scratching, scraping,
retracting, the scent, switching and similar practices, which is not associated
with active medical device and can be after the execution
of the processes used,
1. the 9. active medical device medical device, which
activity depends on a source of electrical energy or any source that is not directly
created by the human body or gravity and which acts via
converting this energy; medical devices intended to transmit energy
or substances between active medical device and the patient without
any significant change for active medical device
not be considered; separate software is considered to be active
medical device,
1.10. Active therapeutical device any active medical device
whether used alone or in combination with other medical devices
to support, modify, restore, or modify biological functions
or structures with a view to treatment or alleviation of disease, injury or
disability,
1.11. Active diagnostic medical device active
medical device, whether used alone or in combination with other
medical devices, to supply information to diagnose,
monitoring, detection or treatment of a physiological state, State of health,
diseases or birth defects,
1.12. Central circulatory system the following vessels: arteriae pulmonales,
the aorta, transverse, arcus aortae aorta descendens to the bifurcatio, aortae,
arteriae coronariae, arteria carotid communis, arteria carotid externa,
internal carotid artery, arteriae cerebrales, truncus
brachiocephalicus, venae cordis, venae pulmonales, vena cava superior,
vena cava inferior,
1.13. central nervous system-the brain, the brain's diapers and backbone
spinal cord,
1.14. Endoprosthesis of the hip, knee and shoulder Endoprosthesis Endoprosthesis
The implantable components of total hip replacements, whose task is to
provide a function similar to a natural hip joint, the natural
the knee joint, a natural shoulder joint; This definition is
not apply to ancillary components such as screws, wedges, plates or
Tools.
II.
DETAILED RULES
2.
Detailed rules
2.1. The classification rules shall be governed by the intended purpose of medical
resource.
2.2. If the medical device is intended to be used in combination with
other medical device, the classification rules shall apply for
each device separately.
2.3. Accessories are classified separately from the medical
the resource with which it is used.
2. the 4. Software, which drives a device or influences the use of
medical device belongs to the same class as the this
medical device.
2.5. If there is a medical device designed exclusively or principally to the
use for a specific part of the body, it and is classified by the
the principle of the most critical specified use.
2.6. If the classification of a medical device for several
rules based on the performance of this medical
resource and intended purpose specified by the manufacturer, the
the most stringent rules in the higher risk class.
2.7. In the calculation of the period referred to in point 1. 1. up to 1. 3. of this annex
continuous use means the actual continuous use
medical device for the purpose intended. However, if you use
the medical device is interrupted for the purpose of instant Exchange
the medical device with the same or identical medical
the resource, it is considered a continuation in continuous use
the medical device.
III.
CLASSIFICATION
3.
Classification of non-invasive medical device
3. the 1. Rule 1
Non-invasive medical device belongs to a risk class I, if
subject to rule no. 2, 3 or 4.
3.2. Rule 2
Non-invasive medical device intended for draining or
the collection of blood, body liquids or tissues, liquids or gases for
the eventual infusion, administration or introduction into the body belongs to a risk
class IIa
3.2. 1. can be connected to an active medical device
risk class IIa or a higher class of risk, and
3.2. 2. is designed for evacuation or collect blood or other
body liquids or for storing organs, parts of organs or body
tissue; in all other cases, belongs to a risk class I.
3.3. Rule 3
Non-invasive medical device intended for the modification of biological or
the chemical composition of blood, other body liquids or other liquids
intended for infusion into the body are in class IIb risk; If treatment
consists of filtration, centrifugation or exchanges of gas or heat, include
such a medical device to a risk class IIa.
3.4. Rule 4
Non-invasive medical device which comes into contact with
injured skin, belongs to the
3.4. 1. risk class I, if it is intended to be used as a mechanical
barrier, for compression or for absorption of exudates,
3.4. 2. risk class IIb if it is designed especially for use in healing,
where was breached and where you may have only a secondary therapeutic
the effect,
3.4. 3. risk class IIa in all other cases, including the
the medical device from the specified, in particular for the treatment of micro-environments
the wound.
4.
Invasive medical device classification
4. the 1. Rule 5
Invasive medical device intended to be used for natural
body orifices, other than surgically invasive medical device and
for connection to an active medical device or specified by the
for connection to an active medical device risk class I belong
to
4. the 1. 1. risk class I, if it is intended for temporary use,
4. the 1. 2. risk class IIa is intended for short-term use,
with the exception of use in the oral cavity as far as the pharynx, in an ear canal up to the ear
drum or in a nasal cavity, which belong to a risk class I,
4. the 1. 3. risk class IIb if it is intended for long-term use,
with the exception of use in the oral cavity as far as the pharynx, in an ear canal up to the ear
drum or in a nasal cavity and are not likely absorption
mucous membranes, which belong to a risk class IIa; invasive medical
a resource that relates to body orifices and that is not surgically
invasive medical device and is intended for connection to an active
medical device in class IIa or a higher risk, belongs to the
risk class IIa.
4.2. Rule 6
Any kind of a surgically invasive device for
transient use are in class IIa unless risk is not
4.2. 1. intended specifically to control, diagnose, monitor or correct a
defect of the heart or of the Central circulatory system through direct contact with these
parts of the body, which belongs to the risk class III,
4.2. 2. surgical tool for reuse, which belongs to the
risk class I,
4.2. 3. specially designed for direct contact with the central nervous system,
When it belongs to a risk class III,
4.2. 4. intended to supply energy in the form of ionizing radiation in which
It belongs to a risk class IIb,
4.2. 5. intended to have a biological effect or to be full or the vast
absorption, which belong to a risk class IIb,
4.2. 6. intended to administer medicinal products dosing system, if
This is done in a way to potentially dangerous in terms of the way
the application, which belongs to the risk class IIb.
4.3. Rule 7
Surgically invasive device for short-term use
It belongs to a risk class IIa, if is not intended
4.3. 1. particularly for the control, diagnose, monitor or correct
heart defects or defects in the Central circulatory system through direct contact with
these parts of the body, which belongs to the risk class III,
4.3. 2. specifically for use in direct contact with the central nervous
system, in which belong to a risk class III,
4.3. 3. to supply energy in the form of ionizing radiation in which belongs to the
risk class IIb,
4.3. 4. to have a biological effect or to be wholly or full
absorption, which belong to a risk class III,
4.3. 5. to undergo chemical change in the body, with the exception of the medical
a resource in the teeth, or to administer medicines, in which belongs to the
risk class IIb.
4.4. Rule 8
Implantable and long-term surgically invasive medical
a resource belongs to a risk class IIb if is not intended to
4.4. 1. location in the teeth, which belong to a risk class IIa,
4.4. 2. the use in direct contact with the heart, the Central circulatory or
the central nervous system, which belong to a risk class III,
4.4. 3. have a biological effect or to be wholly or mainly absorbed,
When it belongs to a risk class III,
4.4. 4. undergo chemical changes in the body, with the exception of the medical
a resource in the teeth, or to administer medicines, in which belongs to the
risk class III.
5.
Active medical device classification
5.1. Rule 9
5.1. 1. active therapeutic medical device intended for feed
or power exchange belongs to the risk class IIa if they are not
properties such that, having regard to the nature, the density and site of application
energy energy to the human body or pass through or out of the body
Exchange in potentially harmful ways, which belongs to the class of risk
IIB.
5.1. 2. Active medical device designed to control or
monitor the performance of active therapeutic medical devices
risk class IIb, or intended directly to influence the effectiveness of such
medical devices belongs to the risk class IIb.
5.2. Rule 10
Active medical device intended for diagnosing belongs to
risk class IIa, if it is intended to
5.2. 1. the administration of the energy that is absorbed by the human body, with the
the exception of a medical device used to illuminate the patient's
the body, in the visible spectrum,
5.2. 2. view the in vivo distribution of radiopharmaceuticals,
5.2. 3. direct diagnosis or monitoring of vital
physiological processes, unless it is specifically designed for monitoring
the vital physiological parameters, where the nature of variations is such,
that could lead to an imminent threat to the user (changes in heart
performance, respiration, activity of the central nervous system), which belongs to the
risk class IIb; active medical device intended to emit
ionizing radiation and intended for diagnostic and therapeutic
Interventional Radiology, including medical device that controls the
or monitor such medical devices or directly affects the
their performance, belongs to a risk class IIb.
5.3. Rule 11
Active medical device designed to administer drugs, body
liquids or other substances into the body or the removal of pharmaceuticals, body
liquids or other substances from the body belongs to a risk class IIa, if
not in a manner that is potentially hazardous taking account of the
the nature of the used substances, parts of the body and the manner of application, include
to a risk class IIb.
5.4. Rule 12
Active medical device which does not comply with paragraphs 5. 1.-5. 3.
of this annex, belongs to a risk class I.
6.
Special classification of the medical device
6.1. Rule 13
6.1. 1. A medical device that includes as an integral part, a substance,
that when used alone, can be considered a drug, and that
can act on the human body effect of complementary effect of the medical
a resource belongs to a risk class III.
6.1. 2. a medical device which incorporates, as an integral
part of the human blood derivative, belongs to a risk class III.
6.2. Rule 14
Medical device used for contraception or for the prevention of
transmission of sexually transmitted diseases belongs to a risk class IIb,
If it is not implantable or long term invasive medical
the means by which belong to a risk class III.
6.3. Rule 15
Medical device specifically intended to be used for disinfecting,
cleaning, rinsing, or hydrating contact lenses, belongs to the
risk class IIb. Medical device specifically intended for use
for disinfecting medical devices belongs to the risk class IIa,
If it is not specifically intended for disinfecting invasive medical
resources, which belong to a risk class IIb; This does not apply for products
intended for the physical cleaning of medical devices that are not
contact lenses.
6.4. Rule 16
Medical device specifically intended for the recording of diagnostic
x-ray view belongs to a risk class IIa.
6.5. Rule 17
Medical device made with the use of animal tissues or
non-living derivatives belong to the high-risk class III, with the exception of
a medical device that is intended to come into contact only with intact
the skin.
6.6. Rule 18
Blood bag belongs to a risk class IIb.
6.7.
Breast implants belongs to a risk class III ^ 10)
6.8.
Hip, knee and shoulder belongs to a risk class III ^ 11).
Annex 10
The criteria for the certification the person
1. the notified body, its statutory authority, the employees and the other persons
carrying out its activities (hereinafter referred to as "employees") responsible for the
the assessment and verification operations may not be the authors of the proposal, manufacturers, suppliers
Neither installers or user of the devices which they inspect, and
they may not be nor the authorised representative of any of those parties. Shall not
directly involved in the design, construction, marketing or maintenance of the devices,
nor represent the parties participating in these activities. This, however,
does not preclude the possibility of exchanges of technical information between the manufacturer and the
entity.
2. the notified body and its staff shall carry out the assessment and
verifications with the highest degree of professional integrity and the requisite
competence in the field of medical devices and must be
exposed to pressures and inducements, particularly financial, which might
influence their judgement or the results of the inspection, especially from persons
or groups of persons, in the result of verifications.
2.1. Subcontract specific tasks connected with the establishment
and verification of the facts, the notified body must first ensure that the
the subcontractor meets the provisions of this regulation, and in particular the
of the annex. Notified body shall keep at the disposal of the national authorities
the relevant documents assessing the subcontractor's qualifications, and job
done under this regulation.
3. the notified body must be able to perform all the tasks that
This person are designed by one of annexes 2 to 7 and for which the
notified, either by itself or on its responsibility.
Notified body must have at its disposal the necessary staff and, in particular,
have the necessary facilities to enable it to perform properly the technical and administrative
tasks connected with the assessment and verification. The assumption is that
notified body will have available sufficient scientific personnel
facilities with sufficient experience and knowledge necessary to assess the
medical performance and efficiency of those funds, for
that has been notified, having regard to the requirements of this regulation, and in particular
the requirements of annex 1 to this regulation. It must also have access to
the equipment necessary for the verifications required.
4. the notified body shall ensure that the
4. the 1. sound vocational training covering all the assessment and verification
the procedures for which it was named,
4.2. satisfactory knowledge of the rules on the inspections which are carried out, and
adequate experience of such tests,
4.3. the ability required to draw up the certificates, protocols and
reports to demonstrate that the inspections have been carried out.
5. Must be guaranteed the impartiality and independence of the notified body. Her
remuneration must not depend on the number of inspections carried out, nor on their
the results.
6. the notified body shall conclude, in accordance with the Act on technical
the Treaty requirements for products liability insurance.
7. the staff of the notified body shall preserve the confidentiality of all
information obtained in the performance of their duties under the law on
technical requirements for products.
8. Additional requirements for the certification the person lays down the right to use
Regulation of the European Union ^ 12).
1) Council Directive 93/42/EEC of 14 June 1993 June 1993 on medical
of transport, as amended by European Parliament and Council Directive 98/79/EC
of 27 June. October 1998, the European Parliament and Council Directive 2000/70/EC
of 16 December 2002. November 2000, directive of the European Parliament and of the Council
2001/104/EC of 7 September 2004. December 2001, regulation of the European Parliament and of the
Council Regulation (EC) No 1882/2003 of 29 September 2003. September 2003 and directive of the European
Parliament and Council Directive 2007/47/EC of 5 July 2004. September 7, 2007.
2) of Decree-Law No. 21/2003 Coll., laying down technical requirements
on personal protective equipment.
3) Act No. 18/1997 Coll. on peaceful uses of nuclear energy and
ionizing radiation (the Atomic Act), and amending and supplementing certain
laws, as amended.
4) § 2 (2). 2 Government Regulation No. 616/2006 Coll., on technical
requirements for products in terms of their electromagnetic
compatibility.
5) of Decree-Law No. 176/2008 Coll., on technical requirements for mechanical engineering
device.
6) Section 4a of the Act No. 22/1997 Coll., on technical requirements for products and on the
amendments to certain laws, as amended.
7) European Parliament and Council Regulation (EC) no 765/2008 of 9 July.
July 2008 setting out the requirements for accreditation and supervision of
market related to the marketing of products and repealing Regulation
(EEC) No 339/93.
8) Law No. 378/2007 Coll., on pharmaceuticals and on changes of some
related laws, as amended.
9) Act No. 506/1990 Coll., on weights and measures, as amended.
Decree No. 264/2000 Coll., on the basic measuring units and other
units and their labelling, as amended by Decree No. 424/2009 Sb.
10) Commission Directive 2003/12/EC on the reclassification of breast implants in the
framework of Directive 93/42/EEC on medical devices.
11) Commission Directive 2005/50/EC on the reclassification of hip,
the knee and shoulder joint in the framework of Council Directive 93/42/EEC on
medical devices.
12) Commission Regulation (EC) No 920/2013 for the designation of notified bodies
pursuant to Council Directive 90/385/EEC on active implantable
medical devices and Council Directive 93/42/EEC concerning medical
resources and supervision of such bodies.