56/2015 Sb.
REGULATION OF THE GOVERNMENT
of 25 June 2002. March 2015
on technical requirements for diagnostic medical devices in
vitro
The Government ordered pursuant to section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Law No 71/2000 Coll., Act No. 102/2001 Coll., Act No. 205/2002 Sb.
Act No. 34/2011 Coll., Act No. 100/2013 Coll. and Act No. 64/2014 Sb.
(hereinafter referred to as the "law on technical requirements for products") for the implementation of article 2 of the
(a). (d)), section 11 (2). 1, 2 and 9, § 11a paragraph. 2, section 12 and 13 of the Act on
technical requirements for products and in accordance with section 96 paragraph. 1 of law No.
268/2014 Coll., on medical devices and on the amendment of Act No.
634/2004 Coll., on administrative fees, as amended,
(hereinafter referred to as the "law on medical devices") for the implementation of section 5 (a).
l), section 6 (1). 1 (a). (b)) and section 24 of 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 the products.
(2) laid down under this regulation are products within the meaning of section 12, paragraph.
1 (a). and) of the technical requirements for products, diagnostic
in vitro medical devices and their accessories.
(3) this Regulation shall not apply to
and) diagnostic medical devices, which have been produced and
used only in a particular health care facility and in premises where
have been made, or in the premises in the immediate vicinity without having been passed
another legal entity,
b) internationally certified reference materials and materials used
for external assessment of quality systems programs and
(c)) of the instruments, apparatus, equipment or other articles, including software
equipment intended for use for research purposes, without any medical
objectives.
§ 2
Definition of terms
For the purposes of this regulation, means a
and calibration and control materials) of substances, materials or articles
intended by their manufacturer to determine the range of measurement, or to verify
the performance of the in vitro diagnostic medical devices
in accordance with their intended purpose of use,
(b)) new in vitro diagnostic medical device such
in vitro diagnostic medical device, which
1. during the previous 3 years for the relevant analyte or other
parameter available on the market in the Member States of the European
the Union, in the Contracting States to the agreement on the European economic area, in
Switzerland and Turkey (hereinafter referred to as "Member State"), or
2. analytical procedure uses technology during the previous 3
years not continuously used in connection with a given analyte or
other parameter on the market in the Member States,
(c) a summary of the properties of the functional competences) diagnostic medical
the resource specified by the in vitro for its designated purpose of this
in vitro diagnostic medical device.
§ 3
The General principles of
(1) in vitro Diagnostic medical device must comply with the
essential requirements referred to in annex 1 to this Regulation (hereinafter referred to as
"essential requirements"), which is the specific diagnostic medical
in vitro means, taking into account its intended
the purpose of the.
(2) the essential requirements shall be considered satisfied if the diagnostic
in vitro medical device complies with the relevant harmonised
^ 2) standards. For the harmonised standards referred to in this Regulation shall be considered and
common technical specifications for diagnostic medical devices
in vitro according to § 6 (hereinafter referred to as the "harmonized standards").
(3) in the assessment of in vitro diagnostic medical device from the
with regard to its electromagnetic compatibility does not flow under the
Government Regulation, laying down the technical requirements on products from
their electromagnetic compatibility ^ 3).
(4) the information provided by the user in accordance with point 15 of annex 1 to this
Regulation are in Czech language, if it's not about symbols listed in annex
No 1 to this regulation, or in the relevant harmonised standard.
(5) When the sampling of the human organism (hereinafter referred to as "samples") and in
collection and use of substances derived from the human body to proceed in
accordance with the International Convention on human rights and Biomedicine and
the ethical principles set out in the Helsinki Declaration.
§ 4
Conformity assessment procedures
(1) before the in vitro diagnostic medical device on
the market, with the exception of those which are listed in annex 2 to this
Regulation and in vitro diagnostic medical device specified
for performance evaluation, the manufacturer shall, in the provision of
the indication referred to in annex 3 to this regulation, and shall draw up a written
the Declaration of conformity.
(2) in the case of the medical device for self-testing with the exception of the
diagnostic medical device referred to in annex No. 2 to the
of this regulation, and in vitro diagnostic medical device
intended for performance evaluation, the manufacturer prior to the drawing
the written declaration of conformity fulfils the other requirements laid down in point 7
Annex 3 to this regulation, or in accordance with paragraph 3 or 4.
(3) for in vitro diagnostic medical device referred to in
list and in point 1 of annex 2 to this regulation, with the exception of
medical device intended for performance evaluation, the
the manufacturer shall proceed to the procurement of the CE marking in accordance with § 4
According to the
and no 4) of the annex to this regulation, or
(b)) Annex 5 to this regulation, together with the procedure referred to in annex No.
7 to this regulation.
(4) in vitro diagnostic medical device referred to in
list of (B) in point 2 of annex 2 to this regulation, with the exception of
medical device for performance evaluation, the manufacturer
proceeds for the purpose of procuring the CE marking in accordance with § 4 under
and no 4) of the annex to this regulation, or
(b)) Annex 5 to this regulation, together with the procedure referred to in annex No.
6 or 7 of the annex to this regulation.
(5) in cases of a medical device intended for the guest
the performance evaluation, the manufacturer shall proceed as specified in annex 8 to this
Regulation and before placing on the market and/or put into service, shall draw up a written
the Declaration set out in annex 8 to this regulation. This provision
are without prejudice to the provisions relating to the ethical aspects during the implementation of the
studies on evaluation of functional competence for the use of tissues or substances
of human origin.
(6) in the conformity assessment of the diagnostic medical device in
vitro, the manufacturer, the authorised representative or notified shall take into account
the results of any assessment and verification operations carried out in the case of
necessary, in accordance with this regulation in; the production process.
(7) the procedures referred to in annexes 3, 5, 6 and 8 of this Regulation may, instead of
the manufacturer performed its authorized representative.
(8) by way of derogation from paragraphs 1 to 5, the Ministry of health on the
the basis of a duly substantiated request to allow on the territory of the Czech Republic
placing on the market and putting into service of an individual diagnostic
in vitro medical device for which the procedure has not been performed
in accordance with paragraphs 1 to 4 and whose use is in the interest of protection of health.
(9) the manufacturer for a period of 5 years after the manufacture of the last diagnostic
in vitro medical device shall keep the Declaration of conformity,
the technical documentation referred to in annexes 3 to 8 of this
Regulation, reports, certificates, or other decision made
notified persons and the competent administrative authorities for the
control purposes.
(10) if the manufacturer is not established in the European Union, granted on the basis
request the documentation referred to in paragraph 1 the authorized representative.
(11) Includes conformity assessment procedure to obtain participation, then
the manufacturer, or his authorised representative shall request the participation of the
by a person with the appropriate scope of authorization.
(12) the notified body may require, where duly justified, the request
any information or data necessary for establishing and maintaining
verification of conformity with regard to the selected procedure.
(13) the Certificates issued by the certification and other decision
issued in accordance with annexes 3, 4 and 5 to this Regulation shall be valid
After a maximum period of 5 years and may be extended on the basis of the applications submitted by
at the time, to which both parties agreed in the contract signed by both
Parties, and by a further 5 years.
(14) the records and correspondence relating to the procedures referred to in paragraphs 1 to 5
carried out on the territory of the Czech Republic provides in the Czech language,
in another language, if applicable, the approved certification.
(15) the provisions of paragraphs 1 through 14 shall apply mutatis mutandis to any
natural or legal person who manufacturers devices in the field of
the scope of this regulation and that, without placing them on the market, puts them into
service and uses them in the context of his professional activity.
§ 5
The CE Marking
(1) in vitro Diagnostic medical device, with the exception of the
in vitro diagnostic medical device intended for
performance evaluation, which meets the requirements laid down in this
Regulation, prior to the placing on the market and/or put into service, must affix the CE marking,
the design provides for a directly applicable regulation
Union ^ 4).
(2) If the in vitro diagnostic medical device subject to the
other aspects of the specific legislation, which lays down the obligation to
it to affix the CE MARKING, in such a case this term that
in vitro diagnostic medical device, is in accordance with
the requirements that apply to it under these specific legal
regulations.
(3) However, if one or several of the legislation after a transitional
time admits that the manufacturer has chosen, the provisions will govern,
CE marking shall indicate conformity only with those laws or
their provisions, by the manufacturer. In this case, must be in
documentation, notices or instructions required by the competent
legislation, and attached to the appropriate product list
the used legislation and directives, as published in the
The official journal of the European Union, whose requirements were these laws
the provisions were taken.
(4) the CE marking is to be positioned in a visible, legible and indelible form on the
in vitro diagnostic medical device, if it is
practicable and appropriate, and on the instructions for use. If it is possible,
the CE marking shall be placed on the packaging of diagnostic medical
resource in vitro, in which it is sold.
(5) the CE marking, accompanied by the identification number of the notified persons
who is responsible for compliance with the procedure in accordance with the rules referred to in
Annexes 3, 4, 6 and 7 to this regulation.
(6) On in vitro diagnostic medical device, its packaging or in
the instructions accompanying the in vitro diagnostic medical device can be
place another character, provided that it is not reduced visibility or
the legibility of the CE marking. On in vitro diagnostic medical device
cannot connect the marks and inscriptions, which may confuse third persons in
mistake 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; for demonstration
in vitro diagnostic medical device may not be used
a sample taken from the participant of this demonstration.
§ 6
Placing on the market and putting into service
(1) on the market or putting into service of a medical device may be listed,
and) if was laid down by way of assessed compliance of its
properties with the essential requirements and the result of this assessment was
finding that the medical device meets the requirements of this
Regulation and, if properly installed, maintained and used in accordance with the
its intended purpose, is provided with the CE marking, meets the other requirements
referred to in this paragraph and in paragraphs 2 and 4, and the manufacturer has about
written declaration (hereinafter referred to as the "Declaration of conformity"), and
(b)) were to him, accompanied by information on its use in the Czech language in the
accordance with this regulation.
(2) in vitro Diagnostic medical device after placing on the market
monitored by the State Institute for drug control (hereinafter referred to as "the Institute")
with regard to its safety and quality, in accordance with the law on
medical devices.
(3) the provisions of paragraphs 1 and 2 shall also apply to the diagnostic
in vitro medical device is provided for evaluation of the functional
the eligibility of the laboratories or other persons who meet the requirements
set out in section 4, paragraph 4. 5 and in annex 8 to this regulation.
section 7 of the
Common technical specifications
(1) the common technical specifications set
and) criteria for the evaluation and re-evaluation
in vitro diagnostic medical devices, conditions for
the release of production batches,
(b)) reference methods and reference materials for diagnostic
in vitro medical devices referred to in point 1 of Annex No. 2 to the
of this regulation and, where necessary, for diagnostic medical
in vitro means referred to in point 2 of annex 2 to this regulation.
(2) the common technical specifications can be justified when
design and manufacture of in vitro diagnostic medical devices
replace the other solution, which will give at least the same level of
the safety and quality of diagnostic medical devices in
vitro.
(3) the common technical specifications are set out in the decision of the European
the Commission on common technical specifications for diagnostic
in vitro medical devices ^ 5).
§ 8
Notified
(1) the authorization of legal entities under the law on technical
requirements for products shall apply the requirements set out in annex No 9
to this regulation. Legal entities which meet the criteria laid down in
the relevant harmonized standards shall be considered as persons meeting the
the relevant minimum criteria required to obtain credentials.
(2) the notified body and the manufacturer or his authorised representative to
the basis of the agreement lays down the time limits for completion of the evaluation and validation
the activities referred to in annexes 3 to 7 of this regulation.
(3) if the notified person finds out that the manufacturer has failed to fulfil the relevant
the requirements of this regulation or is still fails, or if the certificate
not be published, notified, having regard to the principles of
proportionality, suspend, withdraw or restrict the use of the certificate, which
released, with the exception of cases, when the manufacturer ensure conformity with the following
the requirements of the implementation of appropriate corrective measures. In the case of
suspension, withdrawal, or any other restrictions in the certificate or the
cases where it may be necessary the intervention of the Office for technical standardisation,
Metrology and testing (hereinafter referred to as "the authority"), notified
inform the Office. The Office shall inform the other Member States and the
To the Commission.
(4) the notified body shall inform the authority about all certificates issued, modified,
supplemented, suspended, withdrawn or refused and certificates
shall also inform the other notified parties suspended, withdrawn or
the rejected certificates and, on request, about certificates issued or refused
certificates. Notified also, on request, all
other relevant information on issued certificates.
(5) the Office shall provide the notified on request all relevant
information and documents, including budgetary documents, to enable verification of the
compliance with the criteria laid down in annex 9 to this regulation.
§ 9
Transitional provisions
(1) in vitro Diagnostic medical device marketed prior to the
date of entry into force of this regulation in accordance with the existing laws,
the regulations shall be deemed to in vitro diagnostic medical device
placed on the market in accordance with this regulation.
(2) Authorized and notified the person responsible for the activities in the
conformity assessment according to Decree-Law No 453/2004 Coll., as amended by
amended shall be considered authorized and notified persons
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 2005. April 2015.
The President of the Government:
MSC. in r. Sobotka.
Minister of health:
Mudr. Němeček, MBA, in r.
Annex 1
The basic requirements
(I).
General requirements
1. in vitro Diagnostic medical device must be designed and
designed for use under the specified conditions and for the intended purpose
do not endanger, directly or indirectly, the clinical condition or the safety of patients,
the safety or health of users or other persons, or
the safety of property. Any risks which may, in connection with its
use arise, must be acceptable in comparison with the benefits that
for patients and these properties must match the high level of
the protection of health and safety.
2. The solution, which the manufacturer for the design of diagnostic medical
in vitro, the resource is based on the State of the science and technology corresponding to the
When was this in vitro diagnostic medical device
manufactured. When selecting the most appropriate solutions, the manufacturer complies with the following
the principles in the following order:
2.1. eliminate or reduce risks as far as possible in a safe design and
structures,
2.2. appropriate protection measures against hazards which cannot be
exclude,
2.3. inform the user about the persistence of risk as a result of the imperfections
carried out protective measures.
3. in vitro Diagnostic medical device must be designed and
designed to be suitable for the purposes referred to in the Act on health care
resources in accordance with the manufacturer's specifications, with regard to the General
known the status of science and technology.
4. in vitro Diagnostic medical device must be functional
eligibility laid down by the manufacturer, and it especially comes into account
sensitivity to the analysis, the sensitivity for diagnosis, analysis
diagnostic specificity, pertinence, accuracy, repeatability,
reproducibility, including control of concerning mutual interference,
interference, and the determination of the limit of detection, declared by the manufacturer.
The values that are set for the calibrators or for control
materials, must be verified by using the available reference methods
measurement, or reference materials available to the higher levels.
5. When the load of the in vitro diagnostic medical device,
which may occur under normal operating conditions, shall not be
adversely affected the characteristics and performances referred to in
points 1 to 4 of this annex, to the extent that the threat could occur
health or safety of a patient or user or other persons,
and for the life of diagnostic medical device in
vitro indicated by the manufacturer. If there is no shelf life or life
in vitro diagnostic medical device set, the
the same for a sufficiently predictable shelf life or life
in vitro diagnostic medical device of this type with regard
for its intended purpose and intended use.
6. in vitro Diagnostic medical device shall be designed,
manufactured and packaged so that its properties and performance when
the specified purpose of use have not been adversely affected by the conditions in the
storage or transport, must be maintained with instructions or
information specified by the manufacturer.
II.
Requirements for the design and manufacture of
7.
Chemical and physical properties
7.1. In vitro diagnostic medical device must be designed and
designed to be secured by properties and performance
According to the requirements listed in this annex. Special attention must be
pay reduction options analytical performance due to
incompatibility between the materials used and samples, such as
biological tissues, cells and organisms that are intended for use
along with the in vitro diagnostic medical device to
the intended purpose.
7.2. In vitro diagnostic medical device shall be designed,
manufactured and packaged in such a way as to minimize the risk of leakage of fluid from the
product leakage of contaminants from a contaminated product and
other pollutants during storage, transport and use
in vitro diagnostic medical device, and follow the
the instructions specified by the manufacturer.
8.
Infection and microbial contamination
8.1. In vitro diagnostic medical device and manufacturing processes with the
related are designed so that, if possible, remove or
reduce the risk of infection to the user or other persons. The design must allow
easy handling and, where possible, to minimize contamination and leakage
liquids during use. In the case of containers for samples is necessary to reduce the risk of
contamination of the sample. Production processes must conform to these purposes.
8.2. If the in vitro diagnostic medical device
biological substances, it is necessary to minimize the risk of infection by selecting
suitable donors and appropriate substances and by using appropriate
validated inactivation, conservation, test and control
procedures.
8.3. In vitro diagnostic medical device labelled as either
"STERILE" ("sterile") or as a diagnostic medical device
in vitro in a special microbiological State must be designed, manufactured
and packed in an appropriate package according to the procedures, which ensure that
the manufacturer of the storage and transport conditions laid down, will remain until the
damage to or open the protective packaging in microbiological State,
that corresponds to the marking indicated on the diagnostic medical
in vitro resource when it is placed on the market.
8.4. In vitro diagnostic medical device labelled as either "
STERILE "(" sterile ") or as a diagnostic medical device in
vitro in special microbiological State must be processed
appropriate, validated method.
8.5. Packaging systems for in vitro diagnostic medical device
In addition to those that are listed in section 8. 3. must keep the diagnostic
in vitro medical device without deterioration in the degree of purity of the said
by the manufacturer, and is to be in vitro diagnostic medical device
sterilized prior to use, the system must minimize as much as possible
the risk of microbial contamination. Furthermore, it is necessary to take measures
the most limiting the ability of microbial contamination during selection and handling of
raw materials, manufacture, storage and distribution, in the case that the
performance of the in vitro diagnostic medical device
could be affected by such pollution.
8.6. In vitro diagnostic medical device that is to be
sterilized must be manufactured in appropriately controlled
terms and conditions.
8.7. Packaging systems for non-sterile medical Diagnostics
means an in vitro diagnostic medical device must keep
in vitro without deterioration at the level of cleanliness, and if
in vitro diagnostic medical device intended to be sterilized before the
use, minimise the risk of microbial contamination. Packaging
the system must be suitable taking account of the method of sterilization indicated
by the manufacturer.
9.
Properties in relation to production and the environment
9.1. If the in vitro diagnostic medical device intended to be
use in combination with other medical devices or equipment,
must be the whole combination, including the connection system, safe and not
interfere with the established performance of diagnostic medical
resource in vitro. Any restrictions on use must be indicated on the label
where appropriate, in the instructions for use.
9.2. In vitro diagnostic medical device must be designed and
manufactured to the highest possible degree of minimized risks
associated with its use in the presence of the materials, substances and gases with
under normal conditions of use which may come into contact.
9.3. In vitro diagnostic medical device is designed and
designed to minimise the risk of
9.3. 1. injuries resulting from the physical properties of the diagnostic
in vitro medical device,
9.3. 2. associated with a sufficiently foreseeable external influences, such as
magnetic fields, external electrical influences, electrostatic discharge, pressure
and air humidity, temperature or pressure changes, or acceleration, or random
the penetration of substances into the diagnostic medical device in
vitro; in vitro diagnostic medical device is designed and
designed to provide a sufficient internal resistance
electromagnetic interference in order to enable its functions according to
of the intended purpose.
9.4. In vitro diagnostic medical device is designed and
made so that during normal operation and in the presence of one defect was what
the most reduced the risk of fire or explosion. Special attention must be
pay for the in vitro diagnostic medical device, which
the specified purpose of flammable substances or substances that could
cause of ignition.
9.5. In vitro diagnostic medical device is designed and
designed to allow for the management of safe waste disposal.
9.6. Scale for measuring, monitoring or display, including changes to the
colors and other optical indicators, are designed and manufactured in accordance
with ergonomic principles, taking account of the intended purpose of the diagnostic
in vitro medical device.
10.
Measuring functions
10.1. In vitro diagnostic medical device, which is
a tool or device having a primary analytical measuring function is
designed and manufactured so as to provide adequate stability and accuracy
measurement within appropriate accuracy limits, taking account of the intended
purpose and with regard to the available and appropriate measurement methods and materials.
The accuracy limits specified by the manufacturer.
10.2. If the values are expressed numerically, it should be noted in the legal
units in accordance with the law on metrology ^ 6).
11.
Protection against radiation
11.1. In vitro diagnostic medical device is designed
manufactured and packaged in such a way to minimize the exposure of users and
other persons issued from radiation.
11.2. In the event that the in vitro diagnostic medical device
intended to emit potentially hazardous, visible, or
Invisible radiation, they must be the highest possible degree
11.2. 1. designed and manufactured so as to ensure that the characteristics and
the quantity of radiation emitted can be controlled, if appropriate, modify,
11.2. 2. equipped with a Visual or audible alert about such
issue.
11.3. Operating instructions for the diagnostic medical device in
vitro emitting radiation contains detailed information about the nature of the emitted
radiation in vitro diagnostic medical device, information about
protection of the user and on ways of avoiding misuse and of eliminating the risks
arising from the installation.
12.
Electrical safety and electromagnetic compatibility
12.1. In vitro diagnostic medical device containing
electronic programmable systems, including software, is
designed to ensure the repeatability, reliability and functional
capacity of the system according to the intended purpose.
12.2. In vitro diagnostic medical device is designed and
designed to reduce to a minimum the risk of
electromagnetic interference that might affect the operation of another
medical device or equipment in the usual environment.
12.3. In vitro diagnostic medical device is designed and
designed to provided proper installation what was perhaps the most
eliminates the risk of accidental electric shocks during normal use
and in single fault condition.
13.
Protection against mechanical and thermal risks
13.1. In vitro diagnostic medical device is designed and
designed to protect the user against mechanical
the risks. In vitro diagnostic medical device is in
forecasted traffic conditions stable enough. Must be able to
to withstand the stress of the intended operating environment and must
keep this resistance for their estimated useful lives, if they are
complied with all the requirements relating to the inspection and maintenance of the said
by the manufacturer. Where there are risks with regard to the presence of moving
parts, breakage or disconnection or leakage of substances, must be incorporated
the appropriate protective measures. Any guards or other protective
mechanisms included in the in vitro diagnostic medical device
in order to protect, especially prior to the moving parts must be safe
and shall not impede the access to diagnostic medical device in
vitro in normal operation, nor restrict the regular maintenance of this
resource by specifying the manufacturer.
13.2. In vitro diagnostic medical device is designed and
designed to reduce the risk of vibration induced by this
in vitro diagnostic medical device, and that with regard to the
technical progress and of the means available for limiting vibrations, particularly
at source, unless the vibrations are part of the specific functional
the eligibility of the in vitro diagnostic medical device.
13.3. In vitro diagnostic medical device is designed and
designed to reduce the risk resulting from the noise
emits, and taking account of technical progress and of the means available for
reduce noise, particularly at source, unless the noise emitted is
a specific part of the performance of diagnostic medical
resource in vitro.
13.4. Terminals and connectors to the electricity, gas,
or hydraulic and pneumatic energy with which the user must
manipulate, are designed and manufactured so as to minimize the
all the possible risks.
13.5. Accessible parts of the diagnostic medical device in
vitro, except the parts or areas intended to supply heat or
reach given temperatures and their surroundings must not attain a
normal conditions of use of the potentially dangerous temperatures.
14.
Requirements for in vitro diagnostic medical device for
self-testing
14.1. In vitro diagnostic medical device for self-testing
must be designed and constructed so that its activities match the specified
purpose, taking into account the expertise and available resources and users
the influence caused by the variation that may be expected in the user
technical procedures and environment. The information and instructions provided by the
the manufacturer should be easy for users to understand and easily
applicable.
14.2. In vitro diagnostic medical device for self-testing
It is designed and manufactured to
14.2. 1. for the user easy to use and
14.2. 2. reduce to lowest risk of user error when
handling and interpretation of the results.
14.3. In vitro diagnostic medical device shall, where it is
possible, include user control, i.e. a procedure by which the user
can see that during the period of use of the diagnostic medical
a resource for in vitro self-testing eligible in accordance with the specified
the purpose of the.
15.
The information provided by the manufacturer
15.1. For each of the in vitro diagnostic medical device is
provide the information necessary for its safe and proper use, with
taking account of the training and knowledge of the potential users, and to
identification of the manufacturer. The following information shall mean the information on the label and
in the instructions for use. If it is practicable and appropriate, be
the information needed for the safe use of diagnostic medical
in vitro resource listed on the diagnostic medical
resource in vitro, or, where applicable, on the sales
the packaging. If the drive is not full labelling of each diagnostic
in vitro medical device practically feasible, the
information on the packaging, or the instructions for use provided with the
one or more of the in vitro diagnostic medical devices.
15.2. Instructions for use the user is granted or accompanies diagnostic
in vitro medical device or is included in the packaging of one or
more of the in vitro diagnostic medical devices.
15.3. In duly justified and exceptional cases are instructions for
use for the in vitro diagnostic medical device needed
If the in vitro diagnostic medical device can be properly and
used safely without them.
15.4. Where appropriate, information should have the form of symbols. Each
symbol and identification colour used must be in accordance with the
the harmonized standards. In areas for which harmonised standards
There are, it must be the color of the symbols used and described in the accompanying
documentation for the in vitro diagnostic medical device.
15.5. For in vitro diagnostic medical device containing
a substance that may be considered dangerous with regard to properties
and quantity of its constituents and the forms in which they are present, they must be
used relevant danger symbols and labelling requirements are met
According to the relevant regulations.
15.6. In cases where, for lack of space all the information cannot be
connect the in vitro diagnostic medical device or
on its markings, warning signs shall be placed on the label and the other
the information required by this Regulation shall be given in the instructions for use.
15.7. The designation includes the following particulars, which may be
where appropriate, in the form of symbols:
15.7. 1. the name or business name and the address of the registered office or the address of the
the main business of the plant, where appropriate, the address of the place of residence, if the manufacturer is
a natural person; the name or business name and the address of the registered office, if the
the manufacturer is the legal person (hereinafter referred to as "identification data"). U
in vitro diagnostic medical devices imported into
Member States with a view to their distribution in the European Union, must
marking the outer packaging, or instructions for use shall contain the identification
the particulars of the authorised representative,
15.7. 2. the detailed information necessary for the user to uniquely
identification of in vitro diagnostic medical device and the content
packaging,
15.7. 3. the inscription "STERILE" ("sterile"), in the case of sterile diagnostic
in vitro medical device or the background to any statement
a special microbiological State or State of cleanliness,
15.7. 4. manufacturing batch code (hereinafter referred to as "the lot"), before which is given
the word ' LOT ', or the serial number,
15.7. 5. If necessary, specify the date by which the diagnostic
in vitro medical device or its part should be safely
used without degradation of performance expressed in this order:
the year, month, and where applicable, the date,
15.7. 6. in the case of a medical device intended for the guest
the performances, the words "only for performance evaluation",
15.7. 7. where appropriate, a statement indicating that the diagnostic
in vitro medical device is intended for use in in vitro,
15.7. 8. special storage or handling conditions,
15.7. 9. If necessary, special operating instructions,
15.7. 10. where appropriate, the corresponding alert necessary safety measures,
15.7. 11. If the in vitro diagnostic medical device intended
for self-testing, that fact must be clearly indicated.
15.8. If the intended purpose is not obvious to the user, the manufacturer shall indicate this purpose in
instructions for use and on the labelling of diagnostic medical
in vitro resource, if applicable.
15.9. If it is appropriate and practicable, diagnostic
in vitro medical device and separate the components according to the needs of the
marked in terms of batches, to allow all appropriate action to
determine the risks presented by these diagnostic medical
resources in vitro and detachable components.
15.10. Instructions for use, if that is not the nature of the diagnostic
in vitro medical device impossible, contains the following
details:
15.10. 1. set out in points 15. 7.4. and 15. 7.5.
15.10. 2. the composition of the reagent product by nature and amount
or concentration of the active folder or folders, reagents, or the reagents or
kits, and where it comes in the expression that the diagnostic
in vitro medical device contains other ingredients which may
affect the measurement,
15.10. 3. the conditions and the storage period after the first opening of the primary
the package, along with the storage conditions and stability of working
reagents,
15.10. 4. about the performances referred to in point 4 of this annex,
15.10. 5. concerning all the necessary equipment including information
necessary for the identification of such equipment for proper use,
15.10. 6. type the sample planned for use on special
the conditions of collection, preparation and, where appropriate, storage
conditions, including instructions for the preparation of the patient,
15.10. 7. on the procedure to be followed when using the diagnostic
in vitro medical device,
15.10. 8. the procedure of measurement, which is to be followed by a diagnostic
in vitro medical device, as appropriate:
15.10. 8.1. to the essence of the procedure,
15.10. 8.2. the specific properties of analytic functional
eligibility, which are, in particular, the sensitivity, specificity, accuracy,
repeatability, reproducibility, limits of detection and measurement range,
including the information needed to cope with the known relevant interference
effects, limiting the methods and information about the use of the available procedures and
measurement of reference materials by the user,
15.10. 8.3. other necessary procedures or handling before using
in vitro diagnostic medical device such as a reconstitution,
incubation, dilution, checking tools,
15.10. 8.4. to the effectiveness of the request of the special training,
15.10. 9. concerning the mathematical procedure, which is
calculation of the analytical result
15.10. 10. the measures in the event of changes in the analytical performance of the
in vitro diagnostic medical device,
15.10. 11. concerning the appropriate information to the user about the
15.10. 11.1. internal quality control including specific validation
procedures,
15.10. 11.2. the traceability of the calibration of diagnostic medical
in vitro, the resource
15.10. 12. concerning the reference intervals for the quantities found,
including a description of the appropriate reference population,
15.10. 13. on the properties of diagnostic medical device in
vitro allowing the identification of appropriate medical resources or
equipment, the use of which is to obtain the safe and proper combination in
If the in vitro diagnostic medical device must be
installed, connected or used in combination with other health care
means or equipment, to meet the requirements for its intended
the purpose,
15.10. 14. needed to verify whether it is a diagnostic medical
in vitro means of properly installed and can properly and safely
work, including the necessary detailed information on the nature and frequency of the maintenance
and calibration, which are necessary for the proper and safe function, for information about
safe disposal of waste,
15.10. 15. any further treatment or handling needed before the
use of the in vitro diagnostic medical device such as a
sterilization, final Assembly,
15.10. 16. necessary for the case of damage to the protective packaging and details
information on the appropriate processes after reassembly or decontamination, sterilization
15.10. 17. on the appropriate processes to allow reuse
in vitro diagnostic medical device including cleaning,
disinfection, packaging, sterilization, or decontamination and restrictions
number of repeated use, if is a diagnostic medical
in vitro means intended for repeated use,
15.10. 18. regarding the preliminary security measures that must
be adopted sufficiently foreseeable environmental conditions in terms of
exposure to magnetic fields, external electrical influences,
electrostatic discharge, pressure, acceleration, thermal changes
ignition sources, or other circumstances,
15.10. 19. concerning the precautionary safety measures, which must
be taken against any unusual risks related to the use of
or disposal of in vitro diagnostic medical device,
including special protective measures, where diagnostic medical
in vitro resource contains substances of human or animal origin, must
to be paid attention to their possible contagious nature,
15.10. 20. on the specifications for the diagnostic medical device in
vitro for self-testing,
15.10. 20.1. the results are expressed and provided in a manner that is
easy to understand for non-specialists,
15.10. 20.2. information is provided along with the Council for the user and
the procedure, if it is positive, negative or ambiguous results and
the possibility of an incorrect positive or negative result,
15.10. 20.3. specific details may be omitted, if the
the other information supplied by the manufacturer is sufficient to enable it to
the user to use a medical device for self-testing and understand
the result obtained,
15.10. 20.4. the information contains the expression that the user should not do
any conclusions about the health impact of the results obtained, without these
the results of the first consulting your doctor,
15.10. 20.5. the information contains the lessons, is a diagnostic
in vitro medical device for self-testing is used for tracking
an existing disease, the patient may alter the way of treatment only if
in this sense, if properly trained,
15.10. 21. the date of issue or the date of the latest revision of the instructions for use.
Annex 2
The list of in vitro diagnostic medical devices referred to in section
4 (4). 3 and 4
The List And The
1. List and contains the following diagnostic medical devices in
vitro:
1.1. reagents and reagent products, including related reactions calibrators
and control materials, for determining the following blood groups Abo system, Rhesus
factor (C, C, D, E, E) and Kell Antigen system (K),
1.2. reagents and reagent products, including related reactions calibrators
and control materials for the license, confirmation and quantification of the indicators
HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D in human
samples,
1.3. tests on the variant Creutzfeldtovu-Jakob disease (vCJD)
blood tests, diagnosis and confirmation.
List B
2. List B includes the following diagnostic medical devices in
vitro:
2.1. reagents and reagent products, including related reactions calibrators
and control materials, for determining the following blood groups of anti-
Duffy and anti-Kidd,
2.2. reagents and reagent products, including related reactions calibrators
and control materials, for determining irregular antibodies
erytrocytům,
2.3. reagents and reagent products, including related reactions calibrators
and control materials, for the detection and quantification of rubella and
Toxoplasma in human samples,
2. the 4. reagents and reagent products, including related reactions calibrators
and control materials, for the diagnosis of phenylketonuria
2.5. reagents and reagent products, including related reactions calibrators
and control materials, for determining the Cytomegalovirus and chlamýdií,
2.6. reagents and reagent products, including related reactions calibrators
and control materials, for determining the following HLA tissue groups DR, A, B,
2.7. reagents and reagent products, including related reactions calibrators
and control materials, for determining the tumoral marker, PSA
2.8. agents with the results of the reaction products, including related calibrators
and control materials and software, designed for
the specific assessment of the risk of trisomy 21. the chromosome,
2.9. in vitro diagnostic medical device designed to measure the
blood sugar, marketed as a diagnostic medical
resource in vitro for self-testing, including relevant
calibrators and control materials.
Annex 3
EC declaration of conformity
1. a declaration of conformity is the procedure whereby the manufacturer or his authorised
Representative, filling the commitments referred to in points 2, 3, 4 and 5 of this annex, and in
the case of a medical device for self-testing, also referred to in point 7
of this annex ensures and declares that the assessed health
in vitro means in accordance with the provisions of this regulation,
which apply to it. The manufacturer affixes the diagnostic medical
in vitro means of CE marking in accordance with section 5.
2. the manufacturer shall draw up technical documentation and ensures that the production
procedures consistent with the principles of quality assurance laid down in point 5 of this
Annex.
3. the technical documentation-ce allows conformity assessment diagnostic
in vitro medical device with the requirements of this regulation.
4. the technical documentation shall include in particular the
4. the 1. a general description of the in vitro diagnostic medical device
including the variants planned,
4.2. the quality system documentation,
4.3. information about the construction, including the determination of the basic properties
materials, characteristics and limitations of performance
in vitro diagnostic medical device, manufacturing technology
and in the case of instruments, design drawings, part of the scheme, and subassemblies
circuits,
4.4. in the case of in vitro diagnostic medical device
containing tissues of human origin or substances derived from such
tissues, information about the origin of such material, and on the conditions under which
has been removed,
4.5. Description and explanations necessary for the understanding of the above
characteristics, drawings and diagrams and the activities of the diagnostic
in vitro medical device,
4.6. the results of the risk analysis and, where applicable, the list of fully
or partially applied harmonised standards and descriptions of the solutions adopted
to meet the essential requirements of this regulation if the harmonised
the standards have not been applied in full,
4.7. in the case of sterile diagnostic medical device in
vitro diagnostic medical device or in vitro,
a special microbiological State or degree of purity, description of
procedures,
4.8. the results of the design calculations and of the inspections carried out,
4.9. If it is to be in vitro diagnostic medical device associated with the
other in vitro diagnostic medical device with the intention of
achieve the intended purpose, it must be demonstrated that, in conjunction with the
any such in vitro diagnostic medical device
having the characteristics specified by the manufacturer is in compliance with the essential
requirements,
4.10. test records
4.11. adequate performance evaluation data showing the
performance of the declared by the manufacturer and supported by a reference
If the measurement system is available, along with information on the reference
methods, the reference materials, the known reference values, the
the accuracy and measurement units used; These data are derived from studies
in the clinical or other appropriate environment or refer to
the corresponding data in the literature,
4.12. marking and instructions for use,
4.13. the results of the stability studies.
5.
-Quality assurance
5.1. The manufacturer shall ensure that the necessary measures to ensure that the manufacturing process
maintaining the quality of the corresponding security policies produced
in vitro diagnostic medical devices.
5.2. The system is focused on
5.2. 1. the organisational structure and responsibilities,
5.2. 2. the manufacturing processes and systematic quality control of production,
5.2. 3. the means to monitor the performance of the quality system.
6.
Obligations after the placing on the market
6.1. The manufacturer shall Institute and keep updated a systematic procedure for
the evaluation of the experience gained with the diagnostic medical
an in vitro to the market, including the evaluation of the functional
in accordance with the law on medical devices.
Part of this commitment, the manufacturer is to notify the Institute of adverse events
According to the law on medical devices shall immediately, but not later than
within 15 days from the date of the finding.
6.2. The manufacturer shall establish adequate measures to facilitate the implementation of
any necessary corrective actions, taking account of the nature and
the risks associated with diagnostic medical device in
vitro.
7.
The specific procedure for in vitro diagnostic medical device for
self-testing
7.1. For in vitro diagnostic medical device for
self-testing the manufacturer shall lodge an application for examination of the notified person
the proposal.
7.2. The application shall enable understanding of the design of the diagnostic
in vitro medical device for self-testing and contains
documents to allow assessment of conformity with the requirements of this regulation,
relating to the proposal.
7.3. The request contains
7.3. 1. the results of the tests and, where applicable, also the results of the
studies carried out by non-professionals,
7.3. 2. data documenting the appropriateness of treatment with diagnostic
in vitro medical device for self-testing with regard to its
intended purpose for self-testing,
7.3. 3. the information that is provided with diagnostic
in vitro medical device for self-testing on its label and
in the instructions for use.
7.4. Notified person examine the application and where the design meets
the relevant provisions of this regulation, it shall issue to the applicant a certificate of
a review of the proposal. Notified body may require the replenishment request
other tests or evidence in order to assess compliance with the requirements of
This regulation relating to the proposal.
7.5. Design examination certificate contains the findings of the investigation, the terms of
of validity, the data needed for identification of the approved design and, where it
applicable, a description of the intended purpose of diagnostic medical
resource in vitro for self-testing.
7.6. The applicant shall inform by the person who issued the certificate of
design review, of any substantial modification to the approved design.
If the changes could affect conformity with the essential requirements or
affect the prescribed conditions for use of the diagnostic
in vitro medical device for self-testing, these must be
the changes approved by the person who issued the certificate of
a review of the proposal. This additional approval is done in the form of
a supplement to the design examination certificate.
Annex 4
EC declaration of conformity
The full quality assurance system
1. the manufacturer must ensure application of the quality system approved for the design,
manufacture and final inspection of the appropriate diagnostic medical
resource in vitro according to point 6 of this annex.
2. the manufacturer shall be subject to the audit referred to in paragraph 7 and the surveillance referred to in point 9 of this
Annex.
3. for in vitro diagnostic medical device referred to in point 1
Annex 2 to this regulation, in addition, the manufacturer shall follow the points 8 and
10 of this annex.
4. the system of full security quality is the procedure whereby the manufacturer, filling
the obligations referred to in point 1 of this annex, and ensures and declares that the
in vitro diagnostic medical device, is in accordance with the
the provisions of this regulation, which is applicable to it.
5. the manufacturer affixes the in vitro diagnostic medical device
the CE marking in accordance with section 5 and shall draw up a written declaration of conformity.
6.
The quality system
6.1. The manufacturer shall submit a written request to the notified person assessment
your quality system.
6.2. The request contains
6.2. 1. the name or business name and the address of the registered office or the address of the
the main business of the plant, where appropriate, the address of the place of residence, if the manufacturer
is a natural person; the name or business name and the address of the registered office, if the
the manufacturer is a legal person; in both cases, including the addresses of production
the places for which applies the quality system,
6.2. 2. adequate information on the diagnostic health care resource
in vitro diagnostic medical device or category in
vitro, for which the procedure applies,
6.2. 3. a written declaration that no other person was not notified
a request for the same quality system related to diagnostic
medical resource in vitro
6.2. 4. the quality system documentation,
6.2. 5. an undertaking to fulfil all the requirements arising from the
the approved quality system,
6.2. 6. an undertaking to maintain the quality system in a reasonable and effective
the State,
6.2. 7. an undertaking to implement and regularly update systematic
procedure to review experience gained of diagnostic medical
resource in vitro in the post-sale phase, and using appropriate resources
take the necessary corrective action and notification in accordance with point 6 of the
Annex 3 to this regulation.
6.3. Applicable quality system assures that Diagnostics
in vitro medical device conforms to the provisions on it
subject to the provisions of this regulation and of the Act on medical devices, and
in every stage, from design to final inspection.
6.4. The elements, requirements, and measures taken by the manufacturer, for it applied
the quality system must be documented in a systematic and proper form
in writing drawn up programmes and procedures such as quality programmes,
quality plans, quality manuals and quality records.
6.5. The quality system documentation shall contain in particular a description of the
6.5. 1. the objectives of the quality specified by the manufacturer,
6.5. 2. Organization of the manufacturer, in particular
6.5. 2.1. organizational structures, the responsibilities of the managerial staff
and their organizational Authority relating to the design and quality of
manufacture of in vitro diagnostic medical device,
6.5. 2.2. methods of monitoring the operation of the quality system and in particular its
the ability to achieve the desired quality of design and produced
in vitro diagnostic medical device, including checks
such in vitro diagnostic medical device, which
the required quality is below,
6.5. 3. the procedures for monitoring and verifying the design of the diagnostic
in vitro medical device, in particular
6.5. 3. the 1. General description of the diagnostic medical device in
vitro including planned variant,
6.5. 3.2. all documentation referred to in points 4. 3. to 4. 13.
Annex 3 to this regulation,
6.5. 3.3. in the case of in vitro diagnostic medical device
for self-testing, the information referred to in point 7 of annex 3 to this
Regulation,
6.5. 3.4. applied control and design verification techniques, processes and
systematic measures used when designing the diagnostic
in vitro medical device,
6.5. 4. the checks and quality assurance techniques at the manufacturing stage,
in particular, the
6.5. 4. the 1. the methods and procedures that will be used, in particular with regard to the
sterilization,
6.5. 4.2. procedures relating to the purchase,
6.5. 4.3. procedures to identify diagnostic medical
resource in vitro, drawn up and kept up-to-date in
each stage of production on the basis of drawings, specifications and other
related documents,
6.5. 5. the appropriate tests and trials which will be carried out before
the production, during and after manufacture, the frequency and the description of the
test equipment; backward must be able to adequately identify
calibration of the test equipment.
6.6. The manufacturer carries out the required controls and tests according to
the most recent State of science and technology. Controls and tests shall include
the manufacturing process including a description of the material and the individual diagnostic
in vitro medical devices or each batch of manufactured
in vitro diagnostic medical devices. When testing
in vitro diagnostic medical device referred to in point 1
Annex 2 to this regulation, the manufacturer shall take into account the latest available
information, in particular with regard to the biological complexity and variability
the samples to be tested by the diagnostic medical
an in vitro.
7.
Audit
7.1. the notified body must audit the quality system to determine
whether the system meets the requirements set out in points 6. 3. to 6. 6 of this
Annex. Compliance with these requirements for quality systems,
that use the corresponding harmonised standards.
7.2. The evaluation team must have experience with the evaluation
the relevant technologies. The evaluation process includes tour operating
space manufacturer in justified cases and control of production processes
in the operational areas of the suppliers or other parties
manufacturer.
7.3. Notified after the audit of the quality system shall notify the
the producers of the decision, which contains the conclusions of the inspection and the justification
the appreciation.
7.4. The manufacturer shall inform the person who approved the certification system
the quality of any plan for substantial changes to the quality system or
covered with a range of in vitro diagnostic medical devices.
Notified body shall evaluate the proposed changes, the person shall verify whether after these changes the
the quality system still meets the requirements referred to in points 6. 3. to 6.
6. of this annex and shall notify its decision to the manufacturer. This decision
contains the conclusions of the inspection and a reasoned assessment.
8.
Examination of the design
8.1. For in vitro diagnostic medical devices referred to in item 1
Annex 2 to this regulation, in addition to compliance with the obligations referred to in points 6 and 7
of this annex, the manufacturer shall obtain from the person of the request for reconsideration
the proposal relating to diagnostic medical device in
vitro, which the manufacturer intends to produce, and that is set out in points 6. 1.
and 6. 2. of this annex.
8.2. The request describes the design, manufacture, and contains data on the functional
the eligibility of the in vitro diagnostic medical device.
Contains documents, which allow to evaluate whether diagnostic
in vitro medical device complies with the requirements referred to in point 6. 5.3.
of this annex.
8.3. Notified body shall examine the application and, if the
in vitro medical device complies with the relevant requirements of this
Regulation, shall issue a design examination certificate to the applicant of the diagnostic
in vitro medical device. Notified may request
complete the request more tests or proof to allow assessment
the conformity of the in vitro diagnostic medical device with the requirements of
of this regulation. Design examination certificate contains the conclusions of the
examination, conditions for its validity, the data needed to
the identification of the approved design of the diagnostic medical
resource in vitro, a description of the intended purpose.
8.4. Changes to the approved design that may affect the conformity with the
the essential requirements of this regulation or the conditions prescribed for the
use of the in vitro diagnostic medical device, subject to the
the additional approval by the person who issued the certificate of
a review of the proposal. The applicant shall inform by the person who released
design examination certificate of all modifications to the approved design.
This additional approval in the form of a supplement to the examination certificate
the proposal.
8.5. The manufacturer shall inform without delay by the person of the
the data relating to changes of pathogens and infectious diseases markers
that are examined, especially if any changes have occurred as a result of biological
the complexity and variability. In this connection, the manufacturer shall inform the
by person, whether any of these changes could affect the
performance of diagnostic medical device in
vitro.
9.
Supervision
9.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
9.2. The manufacturer authorizes the person to carry out the certification of all necessary
the surveys and provide it with all relevant information, in particular
9.2. 1. the quality system documentation,
9.2. 2. the information provided by the quality in the design area, especially
the results of analyses, calculations, tests,
9.2. 3. the information provided for quality system for production, especially
News of the inspections and the data from the test data, calibration data, and reports on the
the qualifications of the personnel concerned.
9.3. Notified body performs
9.3. 1. regular inspection and appropriate evaluation so that the
make sure that the manufacturer applies the approved quality system and provides
the producers of the assessment report,
9.3. 2. at its discretion, the manufacturer and unannounced checks,
in which it is entitled to, if necessary, carry out or ask
perform tests in order to check that the quality system is properly
an effective inspection and, where appropriate, the outcome of the test, if the
was carried out, providing the report.
10.
Validation of in vitro diagnostic medical devices referred to in
point 1 of Annex No. 2
10.1. In the case of in vitro diagnostic medical devices
referred to in point 1 of annex 2 to this regulation, the manufacturer shall promptly
It shall provide the notified person after the termination of the investigation and control tests
the relevant records of the tests conducted on the produced diagnostic
in vitro medical devices or each batch of these
resources.
10.2. Furthermore, the manufacturer shall provide to the notified party samples produced
in vitro diagnostic medical devices or batches
These resources in accordance with pre-agreed conditions and modalities.
10.3. The manufacturer may indicate the in vitro diagnostic medical device
on the market, unless the notified body in the agreed period of time not longer than
30 days after receipt of the samples do not notify the producers of another decision, containing the
in particular any condition of validity of the issued certificates.
Annex 5
EC declaration of conformity
Type-examination
1.
Type-examination of the in vitro diagnostic medical device is
part of the procedure whereby a notified body ascertains and certifies that the
a representative sample of the considered production of diagnostic medical
resource in vitro (hereinafter referred to as "type a") complies with the relevant provisions of the
of this regulation.
2.
Procedure the manufacturer
2.1. The manufacturer or his authorized representative so requests by
person type examination diagnostic medical device in
vitro.
2.2. The request contains
2.2. 1. the name or business name and the address of the registered office or the address of the
the main business of the plant, where appropriate, the address of the place of residence, if the manufacturer
is a natural person; the name or business name and the address of the registered office, if the
the manufacturer is a legal person,
2.2. 2. the name or business name and the address of the registered office or the address of the
the main business of the plant, where appropriate, the address of the place of residence, if the request
authorised representative who is a natural person; name or business
name and address of the registered office, if the application is lodged by the authorized representative, which is
a legal person,
2.2. 3. the documentation referred to in point 2. 3. of this annex, which is needed to
the conformity assessment of the type of the in vitro diagnostic medical device
with the requirements of this regulation,
2.2. 4. type; notified person's sole discretion may require the
For more samples,
2.2. 5. a written declaration that the same application has not been submitted to any other
notified to the person.
2.3. The documentation must allow an understanding of the design, manufacture and operational
the eligibility of the in vitro diagnostic medical device.
The documentation includes, in particular,
2.3. 1. General description of the type, including any variants planned,
2.3. 2. the documentation referred to in point 4. 3. to 4. 13. Annex 3 to the
of this regulation,
2.3. 3. in the case of in vitro diagnostic medical device
for self-testing, the information referred to in point 7 of annex 3 to this
of the regulation.
3.
How to obtain
3. the 1. Notified body shall examine and assess the documentation and verify that the
He was the type of in vitro diagnostic medical device manufactured in the
accordance with the documentation, and records all of the items that are
designed in accordance with the relevant harmonised standards, as
items that are not designed according to the following harmonised standards.
3.2. Notified person shall carry out or have carried out appropriate checks
and the tests necessary to verify whether the solutions adopted by the manufacturer meet the
the essential requirements of this regulation, and in the case of non-application
the harmonised standards. If for the purpose intended to be diagnostic
in vitro medical device combined with other diagnostic
in vitro medical device, it must be demonstrated that the system or
the kit as a whole, complies with the essential requirements and the characteristics of the
specified by the manufacturer.
3.3. Notified person shall carry out or have carried out appropriate checks
or the tests necessary to verify whether the manufacturer actually used
the corresponding harmonised standards, which has chosen,
3.4. Notified body agree with the applicant the location where the necessary
the checks and tests carried out.
4.
The conditions for the release of the documents by a person
4. the 1. If it satisfies the type of in vitro diagnostic medical device
the provisions of this regulation and of the Act on medical devices,
notified body shall issue the applicant the type examination certificate.
4.2. The type examination certificate contains
4.2. 1. the name or business name and the address of the registered office or the address of the
the main business of the plant, where appropriate, the address of the place of residence, if the manufacturer
is a natural person; the name or business name and the address of the registered office, if the
the manufacturer is a legal person,
4.2. 2. the conclusions of the inspection, the conditions of validity and the data needed for
identification of the approved type; the relevant parts of the documentation must be
attached to the type-examination certificate; a copy of the certificate of
type-examination and the relevant parts of the documentation attached to the certificate
type-examination shall keep the notified person.
4.3. The manufacturer shall inform without delay by the person who released
the type examination certificate, of the data relating to
changes to the pathogen and markers of infections, which are examined, in particular if the
These changes as a consequence of biological complexity and variability. In this
context, the manufacturer shall inform the person about the certification, whether any
These changes could affect the performance of diagnostic
in vitro medical device.
4.4. For changes to the approved diagnostic medical device in
vitro is the need to obtain additional consent, that the certificate of
type-examination, and in the case where changes may affect the conformity of the
with the essential requirements of this regulation and with the conditions laid down
for the use of the in vitro diagnostic medical device. The applicant
inform by the person who issued the certificate examination
the type of any significant change made to the approved diagnostic
medical resource in vitro. This additional approval in the form of
addition to the original type-examination certificate.
5.
Transmission of documents
Notified persons may receive copies of the type-examination certificates,
where appropriate, their additions. The annex to the type-examination certificates shall
be available to the other notified parties on the basis of their reasoned
the application and informed the manufacturer.
Annex 6
EC verification
1.
Verification is the procedure whereby the manufacturer or his authorised representative
ensures and declares that the products which have been subjected to the procedure referred to in
point 3 of this annex, corresponding to the type described in the certificate of
type-examination and satisfy the requirements of this regulation.
2.
Procedure the manufacturer
2.1. The manufacturer shall carry out the necessary measures to ensure that the produced
in vitro diagnostic medical device conforms to the type referred to in
type-examination certificate and satisfies the requirements that it
subject to the provisions of this regulation.
2.2. The manufacturer must draw up the documentation before you start the production
defining the manufacturing process
2.2. 1. where necessary, in particular with regard to sterilization and the appropriateness of the
raw materials, and defines the required test procedures according to the current state of the
Science and technology,
2.2. 2. introduce the routine, pre-established provisions to ensure
the homogeneity of production and the conformity of the diagnostic medical device
in vitro with the type described in the EC type-examination certificate and with the
the requirements that apply to it under this regulation.
2.3. In the event that certain aspects the final testing according to section 5.
3. this annex is not appropriate, the manufacturer with the consent of the notified
the person reasonable methods for testing, monitoring, and control
procedures. The provisions of point 9 of annex 4 to this Regulation shall apply in
relation to the abovementioned approved procedures.
2. the 4. The manufacturer shall Institute and keep updated a systematic procedure for
the evaluation of the experience gained with the diagnostic medical
an in vitro in the post-production phase and for the application of the relevant
the measures referred to in point 6 of annex 3 to this regulation.
3.
How to obtain
3. the 1. Notified the person carry out the appropriate examinations and tests
referred to in point 2. 3. of this annex the conformity of diagnostic
in vitro medical device with the requirements of this regulation in accordance with
the decision of the manufacturer
3. the 1. 1. for each of the in vitro diagnostic medical device
referred to in point 4 of this annex, or
3. the 1. 2. for in vitro diagnostic medical devices selected
statistically according to point 5.
3.2. When the statistical verification referred to in point 5 of this annex, the notified body
a person decide whether statistical procedures must be used for the continuous
Control batches, or for separate control of the lot. This decision shall
shall, after consultation with the manufacturer. If the implementation of the examination and tests
on the statistical basis of the question, the examination and tests may
be carried out at random, provided that such procedure in conjunction with
measures taken in accordance with point 2. 3. this annex provides
an equivalent level of conformity.
4.
The verification of an examination and testing of each piece
4. the 1. Notified body assesses each diagnostic medical
in vitro means individually, in order to verify the conformity of each
in vitro diagnostic medical device with the type as described in the
type-examination certificate and with the requirements that apply to it
of this regulation. Notified body performs appropriate tests
laid down in the relevant harmonised standard and, if necessary, be carried out
equivalent tests.
4.2. Notified person place or allow to place on each approved
in vitro diagnostic medical device identification number and
draw up a written certificate of conformity relating to the tests carried out.
5.
Statistical verification
5.1. The manufacturer shall submit to the in vitro diagnostic medical devices
manufactured in homogeneous lots.
5.2. Notified of every batch of one or more randomly
the selected samples. In vitro diagnostic medical devices, which
This sample are examined and subjected to the relevant tests
laid down in the relevant harmonised standard, or equivalent
the tests, to be verified by matching the diagnostic medical
resource in vitro with the type described in the type-examination certificate and
with the requirements of this regulation which apply to it to be
decision on the acceptance of the lot.
5.3. Statistical verification of diagnostic medical devices in
vitro is based on properties, or variations of collection schemes with
operational characteristics which ensure a high level of safety and
performances referred to in the present state of science and technology. Plan
the sampling shall be determined in accordance with the harmonised standards and the
in view of the specific nature of diagnostic medical
resources in vitro.
5.4. If the notified person lot, place or leave
place on each of the in vitro diagnostic medical device your
identification number and shall draw up a written certificate of conformity with reference
the tests performed. All diagnostic medical devices in
vitro from the batch may be placed on the market except those that
failing.
5.5. If the notified body shall evaluate the lot as unsatisfactory,
shall take appropriate measures to prevent the placing on the market a lot.
5.6. In the case of repeated refusal of approval, the lot may be notified
the person suspend the statistical verification.
5.7. The manufacturer may, on the responsibility of the notified person to connect to
in vitro diagnostic medical device identification number
notified persons already during the production process.
Annex 7
EC declaration of conformity
Production-quality assurance
1. The manufacturer ensures the application of the quality system approved for the
manufacture of in vitro diagnostic medical device and
subject to audit in accordance with point 5 of this annex and the surveillance referred to in point 6 of this
Annex.
2. Quality assurance of the production is a part of the procedure whereby the manufacturer
performing the obligations referred to in point 1 of this annex, and ensures and declares that the
the in vitro diagnostic medical device corresponds to the type of
described in the EC type-examination certificate, and that is in accordance with the
the provisions of this regulation that apply to them.
3. the manufacturer affixes the in vitro diagnostic medical device
the CE marking in accordance with section 4 and shall draw up a declaration of conformity.
4.
The quality system
4. the 1. The manufacturer shall submit to the notified person a written request for evaluation
your quality system.
4.2. The request contains
4.2. 1. the name or business name and the address of the registered office or the address of the
the main headquarters of the commercial plant, where appropriate, the address of the place of residence, if the
the manufacturer is a natural person; the name or business name and the address of the registered office,
If the producer is a legal person,
4.2. 2. documentation and undertakings referred to in point 6. 2. Annex 4 to the
of this regulation and
4.2. 3. the technical documentation relating to the approved type and
a copy of the type-examination certificate.
4.3. The application of the quality system ensures that the produced diagnostic
in vitro medical device corresponds to the type described in the certificate
type-examination. All the elements, requirements, and procedures adopted by the manufacturer
for his quality system must be documented in a systematic and
organized way in the form of written statements of policy and procedures. This
the quality system documentation must permit uniform interpretation of the quality policy
and procedures such as quality programmes, plans, manuals and records.
4.4. The documentation includes, in particular, an adequate description
4.4. 1. the objectives of the quality specified by the manufacturer,
4.4. 2. Organization of the manufacturer, in particular
4.4. 2.1. organizational structures, the responsibilities of the managerial staff
their powers in relation to the quality of design and manufacture of diagnostic
in vitro medical device,
4.4. 2.2. the methods of monitoring the effectiveness of the quality system and in particular its
the ability to achieve the desired quality of diagnostic medical
resource, including in vitro diagnostic medical checks
in vitro means, which do not reach the desired quality,
4.4. 3. checks and quality assurance techniques at the manufacturing stage, in particular
4.4. 3. the 1. procedures, and processes that will be used, in particular as regards the
sterilization,
4.4. 3.2. procedures in relation to purchasing,
4.4. 3.3. identification of diagnostic medical procedures
resource in vitro produced, maintained and updated in all
stages of production on the basis of drawings, specifications and other related
documents,
4.4. 4. the appropriate tests and trials which will be carried out before
the production, during and after manufacture, the frequency and the test
the device; the backward-it must be possible to determine adequately the accuracy
the calibration of the test equipment.
5.
Audit
5.1. Notified body audits the quality system for production,
to determine whether a quality system satisfies the requirements of the production according to the
points 4. 3. and 4. 4. of this annex. Compliance with these requirements is
presumed for systems of production quality, in which it is used
the corresponding harmonised standards.
5.2. The team conducting the assessment of the quality system of production must have
experience with assessments of the relevant technology. The evaluation procedure
includes a tour of the premises of the manufacturer in justified cases and
and control of the production processes in the operational areas of the suppliers,
where appropriate, the manufacturer of the subcontractors.
5.3. After the audit of the quality system of the production of notified
notified to the manufacturer or to his authorised representative, a decision which
contains the conclusions of the inspection and a reasoned assessment.
5.4. The manufacturer shall inform the person who approved the certification system
the quality of the production, of the intention to significantly change this system. Notified body
the person shall evaluate the changes proposed and verify whether after these changes the system
production quality still complies with the requirements referred to in points 4. 3. and 4. 4. this
Annex. Manufacturers shall notify its decision, which contains the conclusions of the inspection
and a reasoned assessment.
6.
Supervision
6.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
6.2. The manufacturer authorizes the person to carry out the certification of all necessary
the surveys and provide it with all relevant information, in particular
6.2. 1. the quality system documentation,
6.2. 2. the information provided by the quality in the design area, especially
the results of analyses, calculations, tests,
6.2. 3. the information provided for quality system for production, especially
News of the inspections and the data from the test data, calibration data, and reports on the
the qualifications of the personnel concerned.
6.3. Notified body performs
6.3. 1. carry out the appropriate examinations and assessment periodically to
make sure that the manufacturer applies the approved quality system and provides
the producers of the assessment report,
6.3. 2. at its discretion, the manufacturer and unannounced checks,
in which it is entitled to, if necessary, carry out or ask
perform tests in order to check that the quality system is properly
an effective inspection and, where appropriate, the outcome of the test, if the
was carried out, providing the report.
7.
Validation of in vitro diagnostic medical devices referred to in
point 1 of Annex No. 2
7.1. In the case of in vitro diagnostic medical devices
referred to in point 1 of annex 2 to this regulation, the manufacturer shall promptly
provide the notified person after the conclusion of the investigation and control tests
the relevant records of the tests conducted on the produced diagnostic
in vitro medical devices or each batch of these
resources.
7.2. Furthermore, the manufacturer shall provide to the notified party samples produced
in vitro diagnostic medical devices or batches of these
funds in accordance with pre-agreed conditions and modalities.
7.3. The manufacturer may indicate the in vitro diagnostic medical device
on the market, unless the notified body in the agreed time limit, no more than
30 days after receipt of the samples, any other decision, the manufacturers will not share that contains
in particular any condition of validity of the issued certificates.
Annex 8
Statement of the medical device for performance evaluation
the eligibility of the
1. the manufacturer or his authorised representative shall draw up for the medical
a resource for performance evaluation of the Declaration and to ensure
compliance with the relevant provisions laid down in this regulation.
2. The Declaration means a declaration by the performance evaluation
the law on medical devices and contains
2.1. information allowing identification of the appropriate diagnostic
in vitro medical device,
2.2. an evaluation plan stating in particular the purpose, scientific, technical or
medical grounds, scope and number of diagnostic assessment
in vitro medical devices concerned,
2.3. the list of laboratories or other persons involved in the evaluation
the study,
2. the 4. the start date and scheduled duration for the evaluations and the place and the number of
stakeholders in the case of a diagnostic assessment of the medical
resource in vitro for self-testing,
2.5. a statement that the diagnostic medical device in
vitro is in conformity with the requirements of this regulation, in addition to the rated
aspects and aspects specifically referred to in the Declaration, and that has been made
all precautionary measures to protect the health and safety of patients,
users and other persons.
3. the manufacturer makes available to the competent authorities enabling the documentation
to understand the design, manufacture and performances of the diagnostic
in vitro medical device, including the expected functional
competence to carry out the assessment of conformity of the diagnostic
in vitro medical device with the requirements of this regulation. This
the documentation must be retained for at least 5 years after the end of
performance evaluation.
4. The manufacturer shall take necessary measures necessary to ensure that the manufacturing process
ensures that the manufactured in vitro diagnostic medical device
is in conformity with the documentation referred to in point 1.
Annex 9
The criteria for the certification the person
1. the notified body, its statutory authority, the employees and the other persons
executing its activities (hereinafter "staff") responsible for the
the assessment and verification operations may not be the designer, manufacturer, supplier
Installer or user of the devices which they inspect, and
shall be the authorised representatives of any of these parties. They may 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
by the body.
2. the notified body and its staff shall carry out the assessment and
authentication at the highest level 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 that are in the results of verifications.
2.1. Subcontract specific tasks connected with the establishment
and verification of the facts must be notified first ensure that the
the subcontractor meets the provisions of this regulation, and in particular the
Annex. Notified person shall keep available for the national authorities
the relevant documents assessing the subcontractor qualification and work,
done under this regulation.
3. the notified body must be able to perform all the tasks that
is this person meant by one of annexes 2 to 7 and for which the
notified, either by itself or on its responsibility.
Notified m-must have available the necessary staff and, in particular,
have the necessary equipment, which will enable it to perform properly the technical and administrative
tasks connected with the assessment and validation. The assumption is that the
notified will have available sufficient scientific staff
facilities with sufficient experience and knowledge necessary to assess the
health 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 showing that the inspections have been carried out.
5. Must be guaranteed the impartiality and independence of the person notified. Her
the 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
requirements for products the Treaty on liability insurance.
7. the staff of the notified person shall preserve secrecy about all
the information obtained in the performance of their duties under the law on
technical requirements for products.
1) European Parliament and Council Directive 98/79/EC of 27 June 2002. October 1998
for in vitro diagnostic medical devices, as amended by
Regulation of the European Parliament and of the Council (EC) No 1882/2003 of 29 September 2003. September
2003, the European Parliament and of the Council Regulation (EC) no 596/2009 of 18 December.
June 2009 and 2011/100/EU of 20 December. December 2011.
2) Section 4a of the Act No. 22/1997 Coll., on technical requirements for products and on the
changing and supplementing certain acts, as amended.
3) § 2 (2). 2 regulation of the Government No. 616/2006 Coll., on technical
requirements for products in terms of their electromagnetic
compatibility.
4) Regulation (EC) no 765/2008, setting out the requirements for accreditation and
market surveillance relating to the marketing of products on the market and repealing
Regulation (EEC) No 339/93.
5) Commission decision 2002/364/EC of 7 September 2004. May 2002 on common
technical specifications for diagnostic medical devices in
vitro, in the text of the European Commission decision 2009/886/EC of 27 June 2002.
November 2009 and decision of the European Commission's 2011/869/EU of 20 December.
December 2011.
6) Law No. 505/1990 Coll., on metrology, 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.