Government Decree No. 453 / 2004 Coll.
Government Regulation laying down technical requirements for in vitro diagnostic medical devices
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Regulation
Effective from 04.08.2004
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453
GOVERNMENT REGULATION
of 7 July 2004
laying down technical requirements for in vitro diagnostic medical devices
The Government mandates, pursuant to Article 22 of Act No. 22 / 1997 Coll., on the technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., ("the Act '), to implement Sections 11, 12 and 13 of the Act and to implement Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll., and Act No. 274 / 2003 Coll. (" the Law on medical devices'):
This Regulation amends, following the directly applicable European Union1)
(a) technical requirements for in vitro2 diagnostic medical devices (in vitro diagnostics); and
(b) common technical specifications for in vitro diagnostics.
(1) In vitro diagnostics are specified products in accordance with Article 12 (1) of the Act for which conformity of their properties under this Regulation is assessed.
(2) This Regulation shall also apply to:
(a) in vitro diagnostics manufactured and intended for use for analysis in clinical laboratories without being the subject of trade;
(b) mechanical laboratory equipment specially designed for in vitro diagnostic examinations;
(c) in vitro diagnostics made of tissues, cells or substances of human origin;
(d) in vitro diagnostic accessories treated as separate in vitro diagnostics;
(e) in vitro diagnostics, which are the calibrators and control materials needed to identify or verify the functionality of their user-m3).
(3) This Regulation shall not apply to:
(a) instruments, apparatus, equipment or other objects, including software, intended for use for research purposes without any medical objective;
(b) internationally proven reference materials and materials used for external quality system assessment programmes;
(c) reagents which are manufactured in laboratories of a medical establishment for use in the environment of those laboratories and are not subject to trade;
(d) medical devices (4) for invasive human sampling;
(e) in vitro diagnostics which have been produced in a health facility and are only used in that health facility without being transmitted to another user;
(f) other medical devices manufactured using substances of human origin [except in vitro diagnostics referred to in paragraph 2 (c)].
Interpretation of terms
For the purposes of this Regulation, the following definitions shall also apply:
(a) in vitro diagnostics for self-testing in vitro diagnostics which are intended by the manufacturer to be used by the layman in the home environment;
(b) a summary of the in vitro diagnostic properties determined by the manufacturer for the purpose of using these in vitro diagnostics;
(c) in vitro diagnostics for in vitro verification of performance by the manufacturer for verification of performance carried out in clinical laboratories or other appropriate environments; the activity is not carried out in the manufacturer's premises,
(d) by an authorised representative, a person established in a Member State of the European Union or a European Free Trade Association, who is at the same time a Contracting Party to the European Economic Area (hereinafter referred to as "the Member State"), who is authorised in writing by the manufacturer to act for him with the authorities and authorities in the Member States, having regard to the requirements resulting from this Regulation for manufacturers,
(e) placing on the market the moment when in vitro diagnostics which are not intended for verification of performance move for the first time into distribution on a fee or charge as goods intended for sale in Member States, whether new or fully renewed,
(f) putting into service the moment when in vitro diagnostics prepared for the first time for the intended purpose of use are provided to the end user;
(g) calibration and control materials of substances, materials or articles intended by their manufacturer to determine the extent of measurement or to verify the performance of in vitro diagnostics in accordance with their intended purpose of use;
(h) an accessory to an article which is not an in vitro diagnostic but is intended by the manufacturer specifically for use together with an in vitro diagnostic in order to permit its use in accordance with the purpose specified by the manufacturer; in vitro diagnostic equipment shall not be considered as an accessory to invasive human body sampling;
(i) a new in vitro diagnosis such as:
1. in the previous 3 years, the market in the Member States has not been continuously available to the relevant analyst or other parameter;
2. Uses the analytical technology process which has not been used continuously over the previous 3 years in relation to a given analyst or other parameter on the market in the Member States.
General principles
(1) In vitro diagnostics shall comply with the requirements set out in Annex 1 to this Regulation applicable to them (hereinafter referred to as "essential requirements"), taking into account the intended purpose of use. The essential requirements shall also be deemed to be met if in vitro diagnostics conform to the relevant harmonised standards (5); common technical specifications for in vitro diagnostics (6) shall be considered as harmonised standards under this Regulation.
(2) The sampling of the human organism (hereinafter referred to as "samples') and the collection and use of substances derived from the human body shall be carried out in accordance with the international Treaty (7) and the ethical principles (8).
(3) If the in vitro diagnostics referred to in Sections 5 (1) and 5 (2) are properly installed, maintained and used in accordance with the intended purpose of use and may nevertheless endanger the health and / or life of users or property, the law, the law on medical devices and the special legislation9) shall apply. In particular, the reason for such a procedure shall be:
(a) non-compliance with the essential requirements referred to in paragraph 1;
(b) incorrect application of harmonised standards where it is claimed that they have been applied; or
(c) shortages in the harmonised standards themselves.
(4) The information provided by the user in accordance with point 8 of Part B of Annex 1 to this Regulation must be in the Czech language, except for the symbols listed in Annex 1 to this Regulation or in the relevant harmonised standard (10).
Placing on the market and putting into service in vitro diagnostics
(1) In vitro diagnostics may be presented on the market (11) if:
(a) conformity has been assessed in accordance with Article 8;
(b) comply with the essential requirements and other provisions of this Regulation which apply to them;
(c) a certificate of conformity under this Regulation has been issued for them; and
(d) bear CE12).
(2) In vitro diagnostics may only be put into service if they fulfil the conditions referred to in paragraph 1 and have been supplied and installed accordingly in accordance with the intended purpose of use.
(3) Post-market in vitro diagnostics must be monitored for safety and quality in accordance with Section 12.
(4) The provisions of paragraphs 1 to 3 shall also apply to in vitro diagnostics provided for the verification of their performance to laboratories or other persons meeting the requirements set out in Paragraph 8 (4) and Annex 8 to this Regulation.
Exposure to in vitro diagnostics
Demonstration at exhibitions, fairs and otherwise in vitro diagnostics which do not comply with the requirements of this Regulation may be carried out only if they are visibly marked to show that they cannot be placed on the market and put into service until they comply with the requirements of this Regulation; samples taken from participants in such an demonstration shall not be used for in vitro diagnostics.
Common technical specifications
(1) The common technical specifications provide for:
(a) criteria for:
1. verification and re-evaluation of in vitro diagnostic performance; and
2. release of production batches,
(b) reference
1. methodologies; and
2. materials;
in vitro diagnostics listed in the List A Annex No 2 to this Regulation and, where necessary, in vitro diagnostics listed in List B of Annex 2 to this Regulation.
(2) The common technical specifications may, in duly justified cases, be replaced by another solution in the design and production of in vitro diagnostics achieving at least the same level of safety and quality in vitro diagnostics.
(3) The common technical specifications are set out in the directly applicable European Union12a).
(4) If the common technical specifications cannot be fully verified for compliance with the essential requirements, the procedure shall be followed by law 13).
Conformity assessment procedures
(1) Before placing on the market in vitro diagnostics, with the exception of those listed in Annex 2 to this Regulation and those intended for the verification of performance, the manufacturer shall proceed with the CE marking in accordance with Section 9 and Annex 3 to this Regulation and shall draw up a written EC declaration of conformity. For in vitro self-testing diagnostics prior to the production of the written EC declaration of conformity, the manufacturer shall comply with the additional requirements set out in point 6 of Annex 3 to this Regulation or proceed in accordance with paragraph 2 or 3.
(2) For in vitro diagnostics listed in List A of Annex 2 to this Regulation, except in vitro diagnostics intended for the verification of performance, the manufacturer shall, for the purpose of bearing the CE marking in accordance with Section 9:
(a) Annex 4 to this Regulation; or
(b) Annex 5 to this Regulation, together with the procedure laid down in Annex 7 to this Regulation.
(3) For in vitro diagnostics listed in List B of Annex 2 to this Regulation, with the exception of in vitro diagnostics for the verification of performance, the manufacturer shall, for the purpose of bearing the CE marking in accordance with Section 9:
(a) Annex 4 to this Regulation; or
(b) Annex 5 to this Regulation together with the procedure laid down in Annex 6 or Annex 7 to this Regulation.
(4) In cases of in vitro diagnostics for the verification of the performance of the manufacturer, the manufacturer shall proceed to this Regulation in accordance with Annex 8 and, before making them available, draw up the written declaration set out in that Annex. This provision is without prejudice to the provisions relating to ethical aspects (8) in carrying out performance studies using tissues or substances of human origin.
(5) When assessing the conformity of the manufacturer's in vitro diagnostics and, where appropriate, the notified person( 14), it shall take into account the results of the evaluation and verification procedures, provided that they have been carried out, where appropriate, in accordance with this Regulation in each intermediate production process.
(6) The manufacturer shall, for a period of 5 years after the last in vitro diagnosis, keep the certificates of conformity, the technical documentation referred to in Annexes 3 to 8 to this Regulation, the reports, certificates and, where appropriate, other decisions drawn up by the notified persons and make them available to the competent authorities of the State administration for control purposes.
(7) The manufacturer may instruct his authorised representative to initiate the procedures set out in Annexes 3, 5, 6 and 8 to this Regulation.
(8) If the documentation referred to in paragraph 6 has not been provided by the manufacturer, it shall be provided at the request of the authorised representative, if the manufacturer has been designated.
(9) Where the conformity assessment procedure involves the participation of a notified person, the manufacturer or his authorised representative shall request such participation from the notified person with an appropriate scope of authorisation. The notified body may request the necessary information or data for the approval and compliance with the chosen conformity assessment procedure.
(10) Certificates of the notified person issued in accordance with Annexes 3, 4 and 5 to this Regulation are valid for a maximum period of 5 years and may be renewed for a further period of 5 years, at the request of the manufacturer.
(11) Records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be made in the Czech language and, where appropriate, in another language agreed between the notified person and the manufacturer and, where appropriate, the authorised representative.
(12) In cases where, exceptionally, in vitro diagnostics are not required to assess conformity, the Health Devices Act (15) provides for a procedure.
(13) The provisions of paragraphs 1 to 11 shall apply mutatis mutandis to natural and legal persons who produce in vitro diagnostics and themselves put them into service by using them as part of their professional activities.
In vitro diagnostic labelling
(1) In vitro diagnostics, other than for verification of performance which meet the essential requirements, must bear the CE marking prior to placing on the market.
(2) The in vitro diagnosis referred to in paragraph 1 shall be placed visibly, legibly and indelibly, where practicable and appropriate, and in the instructions for use. The CE marking shall be accompanied by the identification number of the notified person involved in the procedures set out in Annexes 3, 4, 6 and 7 to this Regulation.
(3) In vitro diagnostics shall not include signs and descriptions which may be misinterpreted as being of relevance or graphically similar to the CE marking. Another character may be placed on in vitro diagnostics, their packaging or in instructions accompanying such in vitro diagnostics, provided that neither visibility nor legibility of the CE marking is reduced.
(4) The different parts of the CE marking for in vitro diagnostic medical devices shall have a height not less than 5 mm. This minimum dimension may be adapted for in vitro diagnostics of small dimensions.
(5) Where in vitro diagnostics are subject, from other aspects, to specific legislation which provides for the obligation to affix the CE marking, these indications shall in such a case indicate that in vitro diagnostics also comply with the requirements applicable to them under those specific legislation. However, if one or more laws allow the manufacturer, for a transitional period, to choose which provisions he will follow, the CE marking shall indicate compliance only with those laws or their provisions used by the manufacturer. In this case, the documentation, warnings or instructions required by the relevant legislation and annexed to the relevant products shall include a list of the legislation used and the directives as published in the Official Journal of the European Union, the requirements of which have been adopted by that legislation.
Incorrect use of the CE marking
(1) If the in vitro diagnostic has been found to have been incorrectly marked with the CE marking, the manufacturer or his authorised representative shall remove this unlawful situation in accordance with the instructions of the Czech Trade Inspection16).
(2) If the unlawful situation referred to in paragraph 1 has not been remedied, the specific legislation17) shall be followed.
(3) The provisions of paragraphs 1 and 2 shall also apply to cases where the products bear the CE marking in accordance with the procedures laid down in this Regulation, but do not fall within the scope of this Regulation.
Notification obligations
(1) A manufacturer who places in vitro diagnostics on the market or put into service in accordance with the procedures laid down in Article 5, or an authorised representative notifies the Ministry of Health (hereinafter referred to as "the Ministry") in electronic form
(a) start-up in accordance with Annex 11 to this Regulation;
(b) the cessation of activities in accordance with Annex 11 to this Regulation;
(c) the placing on the market of in vitro diagnostics in accordance with Annex 13 to this Regulation before the in vitro diagnostics are placed on the market;
(d) the cessation of the placing on the market of in vitro diagnostics in accordance with Annex 13 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 13 to this Regulation shall be notified only after the notifier has received a registration number from the Ministry on the basis of compliance with the notification requirement in accordance with Annex 11 to this Regulation.
(2) The notification referred to in paragraph 1 shall also include a new in vitro diagnostic, which shall bear the CE marking.
(3) A person placing in vitro diagnostics on the market or putting into service on the territory of the Czech Republic is required, at the request of the Ministry, to provide information enabling the identification of in vitro diagnostics in accordance with point 2 of Annex 13 to this Regulation and the supporting documents used to assess conformity.
(4) Where a manufacturer intending to place on the market, under his name, an in vitro diagnostic as referred to in paragraph 1 or 2 is not established in a Member State, he shall entrust an authorised representative to the marketing of such in vitro diagnostic.
(5) Pending the launch of the European Data Bank on Medical Devices (18), the Ministry shall notify the information referred to in paragraphs 1 to 3 to the manufacturer having his registered office in a Member State other than the Czech Republic, if he places in vitro diagnostics on the market in the Czech Republic.
(6) The distributor, importer and person performing an in vitro diagnostic service shall notify the Ministry in electronic form
(a) start-up in accordance with Annex 12 to this Regulation;
(b) the cessation of activities in accordance with Annex No 12 to this Regulation; and
(c) an amendment to any of the data notified under (a).
Procedure for preventing and developing adverse events
(1) The prevention and development of adverse events shall be carried out in accordance with the provisions of Section 4 (3) and the Health Intermediation19).
(2) As regards the adverse event of a new in vitro diagnosis to which the CE marking has been attached, the manufacturer shall indicate this in the adverse event report (20).
(3) The State Institute for Drug Control (hereinafter referred to as "the Institute") may, where justified, require information, within 2 years of the notification of an adverse event, on the experience of a new in vitro diagnosis after marketing.
Data set
(1) Data
(a) in vitro diagnostics and persons referred to in Section 11;
(b) the certificates issued, modified, suspended and cancelled, as well as the refusal of applications for certification in accordance with the procedures laid down in Annexes 3 to 7 to this Regulation; and
(c) obtained in accordance with the procedure governing the notification and registration of adverse events (21)
are processed in accordance with this Regulation in an information system under the Health Devices Act (22) until the person handling in vitro diagnostics has notified the Ministry of Discontinuation and for an additional 20 years. Data from the information system are accessible to the Ministry, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as the Office), the Institute, the State Office for Nuclear Safety for Ionizing Radiation Sources, the Institute of Health Information and Statistics of the Czech Republic and the Czech Trade Inspection. Data from the information system on undesirable incidents21) In vitro diagnostics are only accessible to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic.
(2) The information referred to in paragraph 1 (a) shall be made available in electronic form in accordance with Annexes 11 to 13 to this Regulation.
Protective measures and modification of the in vitro diagnostic list as set out in Annex 2
(1) Where in vitro diagnostics are found to be prohibited, restricted or restricted to the availability of health and safety (23), or subject to specific requirements in vitro diagnostics, the Ministry, Institute, Czech Trade Inspection and, where appropriate, other competent authorities shall take appropriate measures under specific legislation24 for a transitional period; These measures include, in particular, the restriction or prohibition of the placing on the market of in vitro diagnostics, withdrawal from the market, or the restriction and prohibition of use in the provision of healthcare. Those measures shall contain precise grounds on which they are based; the measures shall be immediately notified to the person directly concerned, together with information on the remedies and time limits within which the remedies may be lodged.
(2) At the time of preparation of the measures referred to in paragraph 1, the manufacturer or the authorised representative may deliver an opinion on it, unless there is a risk of delay with regard to the protection of health24).
(3) If the Ministry considers that:
(a) the list of in vitro diagnostics listed in Annex 2 to this Regulation should be corrected or extended; or
(b) compliance with in vitro diagnostics or categories of diagnostics should be established by way of derogation, by using one or more procedures selected pursuant to § 8;
submit a duly substantiated request for a decision to the European Commission.
(4) Before submitting an application pursuant to paragraph 3, account shall be taken of:
(a) any relevant information available from the procedures for preventing or developing adverse events and from external quality assessment programmes;
(b)
1. it is possible to rely accurately on the result obtained by the in vitro diagnostic procedure, given that this result has a direct impact on subsequent medical performance,
2. performance based on incorrect results obtained using in vitro diagnostics could prove to be dangerous for the patient and others, in particular as a result of incorrectly positive or incorrectly negative results; and
3. the participation of the notified person would contribute to ensuring compliance with in vitro diagnostics.
Notified persons
(1) The authorisation conditions are set out in Annex 9 to this Regulation; legal persons who comply with the requirements of Czech technical standards, if they fully assume the requirements laid down by the European standard or harmonisation document, are presumed to comply with the relevant criteria for authorisation.
(2) The amended person and the manufacturer or his authorised representative shall, by agreement, set the dates for completion of the evaluation and verification activities referred to in Annexes 3 to 7 to this Regulation.
(3) The Notified Person shall inform the other Notified Persons and the Office of the suspension or revocation of certificates issued by him; inform the other notified persons and the Office, upon request, of the issue of a certificate or refusal of an application for the issue of certificates and provide further relevant information.
(4) Where the notified person finds that the requirements of this Regulation have not been met by the manufacturer or are no longer satisfied, or where the certificate should not have been issued, the notified person shall suspend or revoke the certificate issued or restrict its use, taking into account the principles of proportionality, unless the manufacturer ensures compliance with those requirements by introducing adequate corrective measures. In the event of suspension, restriction or revocation of the certificate or where action by the Office may be necessary, the notified person shall inform the Office thereof.
(5) When informing the competent authorities of other States and the European Commission of certificates that the notified person has changed or cancelled under the previous paragraphs, the law or the law on medical devices shall be applied in accordance with their respective competence.
(6) On request of the Office, the person nominated shall provide relevant information and documents, including budgetary documents, to verify the criteria set out in Annex 9 to this Regulation.
Transitional provisions
(1) In vitro diagnostics meeting the requirements of existing legislation25) may be put into service until 7 December 2005 at the latest.
(2) In vitro diagnostics registered in accordance with § 11 of Government Decree No. 286 / 2001 Coll., laying down technical requirements for in vitro diagnostic medical devices, are considered in vitro diagnostics notified under § 11.
(3) In vitro diagnostics which have been assessed for conformity pursuant to Article 8 of Decree No. 286 / 2001 Coll., laying down technical requirements for in vitro diagnostic medical devices, may be placed on the market in the Czech Republic until 7 December 2005 at the latest, for placing into service only in the Czech Republic.
Repeal
Government Decree No. 286 / 2001 Coll., laying down technical requirements for in vitro diagnostic medical devices, is repealed.
Efficacy
This Regulation shall enter into force on the day of its publication.
Prime Minister:
PhDr. Špidla v. r.
Minister for Health:
Dr. Kubinyi, Ph.D. v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 453 / 2004 Coll.
ESSENTIAL REQUIREMENTS
A. GENERAL REQUIREMENTS
1. In vitro diagnostics shall be designed and constructed in such a way that their use under the specified conditions and for the intended purpose does not jeopardise, directly or indirectly, the clinical condition, safety or health of users, or property, as appropriate. Any risks that may arise in relation to their use must be acceptable compared to the benefit they present to patients and must be consistent with a high level of health and safety protection.
2. The final solution chosen by the manufacturer for the design of in vitro diagnostics shall be based on the state of science and technology corresponding to the time the in vitro diagnostic was manufactured. When selecting the most appropriate solution, the manufacturer shall comply with the following principles in order:
2.1. Eliminate or minimise risks (safe design and construction),
2.2 take appropriate protective measures against risks that cannot be excluded,
2.3. Inform users in case of persistence of risks which have not been removed due to imperfect protective measures.
3. In vitro diagnostics shall be designed and constructed in such a way as to be suitable for the purposes set out in the Law on Medical Devices in accordance with the manufacturer's specification, while respecting the state of science and technology corresponding to the time of manufacture. It shall achieve the performance specified by the manufacturer, in particular taking into account sensitivity to the relevant analysis, sensitivity to diagnosis, analytical specificity, diagnostic suitability, accuracy, repeatability, reproducibility, including checks on interinterference, interference, and determination of the limit of detection declared by the manufacturer.
The values set for calibrators or control materials shall be verified using available reference measurement methods and, where appropriate, higher level materials.
(4) The characteristics and performance referred to in points 1 to 3 shall not change in such a way that the in vitro diagnostic during the shelf-life or service life specified by the manufacturer would endanger the health and safety of the user, even if the in vitro diagnostic is subject to inappropriate conditions or loads which may occur even under normal conditions of use. If the shelf life or life of an in vitro diagnostic is not established, the same shall apply to the sufficiently predictable shelf life or in vitro diagnostic life of this type, taking into account its intended purpose and intended use.
5. In vitro diagnostics shall be designed, constructed and packaged in such a way that their characteristics and performance at the intended purpose of use are not adversely affected by storage or transport conditions (temperature, humidity and so on), while maintaining the instructions or information specified by the manufacturer.
B. REQUIREMENTS FOR PROPOSAL AND PRODUCTION
1. Chemical and physical properties.
1.1. In vitro diagnostics shall be designed and manufactured in such a way as to ensure the characteristics and performance of Part A "General requirements." Particular attention shall be paid to the possibility of reducing analytical performance due to the incompatibility between the materials used and the samples (e.g. biological tissues, cells and micro-organisms) which are intended to be used together with in vitro diagnostics for its intended purpose.
1.2. In vitro diagnostics shall be designed, manufactured and packaged in such a way as to minimise the risks of leakage of fluid from the product, contamination of contaminants from contaminated products and other pollutants during storage, transport and use of in vitro diagnostics, while complying with the manufacturer's instructions.
2. Infections and microbial contamination.
2.1 In vitro diagnostics and production processes related thereto shall be designed in such a way as to eliminate or reduce the risk of infection to users as far as possible. The design shall allow easy handling and, where possible, minimise contamination and leakage of liquids during use. In the case of sample containers, the risk of contamination of the sample must be reduced. The production processes shall comply with those objectives.
2.2. Where in vitro diagnostics of a biological substance are included, the risk of infection must be minimised by selecting an appropriate donor and appropriate substances and by applying appropriate validated inactivation, preservation, test and control procedures.
2.3. In vitro diagnostics marked either as "STERIL" or as in vitro diagnostics in a specific microbiological state shall be designed, manufactured and packaged in appropriate packaging according to appropriate procedures to ensure that the manufacturer's storage and transport conditions remain in the microbiological state until the protective packaging is damaged or opened, which corresponds to the labelling indicated on the in vitro diagnostic when placed on the market.
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Regulation Information
| Citation | Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 04.08.2004 |
|---|---|
| Effective from | 04.08.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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