Technical Data. Requirements For In Vitro Diagnostic Medical Devices

Original Language Title: techn. požadavky na diagnostické zdravotnické prostředky in vitro

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=83852&nr=56~2F2015~20Sb.&ft=txt

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.