Government Regulation No. 56 / 2015 Coll.
Government regulation on technical requirements for in vitro diagnostic medical devices
Valid
Regulation
Effective from 01.04.2015
Text versions:
01.04.2015
31.03.2015
Zobrazeno prvních 200 z celkem 497 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
56
GOVERNMENT REGULATION
of 25 March 2015
on 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 Amendment of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 205 / 2002 Coll., Act No. 34 / 2011 Coll., Act No. 100 / 2013 Coll. and Act No. 64 / 2014 Coll., (hereinafter "Act on Technical Requirements for Products') to implement § 2 (d), § 11 paragraphs 1, 2 and 9 Coll., Section 11a Sb., § 12 and 13 of the Act on Technical Requirements for Products and pursuant to § 96 (1) of Act No. 268 / 2014 Coll., on Medical Devices and Amendment to Act No. 634 / 2004 Coll., as amended, (hereinafter" the Act on Medical Devices') to implement § 5 (l.
Subject matter
(1) This Regulation implements the relevant provisions of the European Union1) and regulates the technical requirements for specified products.
(2) The specified products under this Regulation are within the meaning of Section 12 (1) (a) of the in vitro diagnostic medical devices and accessories.
(3) This Regulation shall not apply to:
(a) diagnostic medical devices which have been manufactured and used only in a given medical facility and in the premises where they were manufactured or in premises directly adjacent to it without being transmitted to another legal entity;
(b) internationally certified reference materials and materials used for external quality system assessment programmes; and
(c) instruments, apparatus, equipment or other objects, including software, intended for use for research purposes without any medical objective.
Definition of terms
For the purposes of this Regulation:
(a) 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 diagnostic medical devices in accordance with their intended purpose of use;
(b) a new in vitro diagnostic medical device which:
1. has not been available continuously for the relevant analyst or other parameter in the Member States of the European Union, in the Contracting States of the Agreement on the European Economic Area, Switzerland and Turkey (hereinafter referred to as "the Member State") during the previous 3 years; or
2. utilises the analytical technology process which has not been used continuously over the previous 3 years in relation to the analyte or other market parameter in the Member States;
(c) a summary of the in vitro diagnostic medical device characteristics determined by the manufacturer for the purpose of this in vitro diagnostic medical device.
General principles
(1) In vitro diagnostic medical devices must comply with the essential requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements") which apply to a particular in vitro diagnostic medical device, taking into account its intended purpose.
(2) The essential requirements are deemed to be met if the in vitro diagnostic medical device complies with the relevant harmonised standard (2). Common technical specifications for in vitro diagnostic medical devices referred to in Article 6 ("harmonised standards') shall also be considered harmonised standards under this Regulation.
(3) When assessing an in vitro diagnostic medical device in terms of its electromagnetic compatibility, no action shall be taken in accordance with the Government Regulation laying down technical requirements for products with regard to their electromagnetic compatibility (3).
(4) The information provided by the user under point 15 of Annex 1 to this Regulation is in the Czech language, except for the symbols listed in Annex 1 to this Regulation or in the relevant harmonised standard.
(5) The sampling and use of substances derived from the human body shall be carried out in accordance with the International Convention on Human Rights and Biomedicine and the ethical principles established by the Helsinki Declaration.
Conformity assessment procedures
(1) Before placing an in vitro diagnostic medical device on the market, with the exception of those listed in Annex 2 to this Regulation and an in vitro diagnostic medical device intended for the assessment of performance, the manufacturer shall proceed with the marking referred to in Annex 3 to this Regulation and draw up a written declaration of conformity.
(2) In the case of a self-testing medical device with the exception of a diagnostic medical device listed in Annex 2 to this Regulation and an in vitro diagnostic medical device intended for the assessment of performance, the manufacturer shall comply with the additional requirements set out in point 7 of Annex 3 to this Regulation before making a written declaration of conformity, or shall comply with paragraph 3 or 4.
(3) In the case of an in vitro diagnostic medical device listed in list A in point 1 of Annex 2 to this Regulation, with the exception of a medical device intended for the evaluation of performance, the manufacturer shall, for the purpose of bearing the CE marking in accordance with Section 4, proceed to:
(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.
(4
(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.
(5) In the case of a medical device intended for the assessment of the performance of the manufacturer, the manufacturer shall proceed to this Regulation in accordance with Annex 8 and, before it is placed on the market or put into service, draw up the written declaration set out in Annex 8 to this Regulation. This provision is without prejudice to the provisions on ethical aspects when carrying out performance studies using tissues or substances of human origin.
(6) When assessing the conformity of an in vitro diagnostic medical device, the manufacturer, the authorised representative or the notified person shall take into account the results of all assessment and verification operations carried out, where appropriate, in accordance with this Regulation in the intermediate production process.
(7) The procedures laid down in Annexes 3, 5, 6 and 8 to this Regulation may be carried out by its authorised representative instead.
(8) By way of derogation from paragraphs 1 to 5, the Ministry of Health may, on duly justified request, authorise the placing on the market and putting into service in vitro of an individual diagnostic medical device for which the procedure referred to in paragraphs 1 to 4 has not been carried out and the use of which is in the interest of health protection.
(9) For a period of 5 years after the last in vitro diagnostic medical device has been manufactured, the manufacturer shall 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 administrative authorities for inspection purposes.
(10) Where the manufacturer is not established in the European Union, the documentation referred to in paragraph 1 shall be provided by his authorised representative upon request.
(11) 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.
(12) The notified person may, if duly justified, request any information or data necessary to establish or maintain the verification of conformity assessment in the light of the procedure chosen.
(13) Certificates issued by the notified person and other decisions made by the notified person in accordance with Annexes 3, 4 and 5 to this Regulation shall be valid for a maximum period of 5 years and may be extended on the basis of an application lodged at the time agreed by both Parties in a contract signed by both Parties for a further period of 5 years.
(14) Records and correspondence concerning procedures under paragraphs 1 to 5 carried out in the Czech Republic shall be made in the Czech language or in another language approved by the notified person.
(15) The provisions of paragraphs 1 to 14 shall apply mutatis mutandis to any natural or legal person who produces funds within the scope of this Regulation and who, without placing them on the market, puts them into service and uses them in the course of his professional activity.
CE marking
(1) The in vitro diagnostic medical device, with the exception of an in vitro diagnostic medical device intended for the assessment of performance which complies with the requirements laid down in this Regulation, shall be marked with the CE marking, the graphic form of which is laid down in the directly applicable European Union4).
(2) Where an in vitro diagnostic medical device is subject, for other aspects, to specific legislation which provides for the obligation to affix it to the CE marking, that indication shall in that case indicate that the in vitro diagnostic medical device also complies with the requirements applicable to it under those specific legislation.
(3) 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 product shall include a list of the legislation applied and the directives as published in the Official Journal of the European Union, the requirements of which have been adopted by that legislation.
(4) The CE marking shall be placed visibly, legibly and indelibly on the in vitro diagnostic medical device, where practicable and appropriate, and in the instructions for use. Where possible, the CE marking shall also be placed on the packaging of the in vitro diagnostic medical device in which it is sold.
(5) The CE marking shall be accompanied by the identification number of the notified person responsible for compliance with the procedure in accordance with the rules set out in Annexes 3, 4, 6 and 7 to this Regulation.
(6) A different character may be placed on the in vitro diagnostic medical device, its packaging or in the instructions accompanying the in vitro diagnostic medical device provided that it does not reduce the visibility or legibility of the CE marking. In vitro diagnostic medical devices may not be accompanied by signs and inscriptions which could mislead third parties as to the meaning and shape of the CE marking.
(7) A medical device which does not bear the CE marking or does not comply with the requirements of this Regulation or of the Law on Medical Devices may be displayed at fairs, exhibitions, demonstration events and other similar events, provided that the visible sign clearly indicates that the device cannot be placed on the market or put into service until it is brought into conformity with this Regulation and the Health Devices Act; a sample taken from a participant in such demonstration shall not be used for in vitro diagnostic medical devices.
Placing on the market and putting into service
(1) A medical device may be placed on the market or put into service:
(a) where the conformity of its characteristics to the essential requirements has been assessed in the manner laid down by it and the result of that assessment has been that the medical device complies with the requirements of this Regulation and is correctly installed, maintained and used in accordance with its intended purpose, bears the CE marking, complies with the other requirements set out in this paragraph and paragraphs 2 and 4, and the manufacturer has issued a written declaration thereof (hereinafter referred to as "the certificate of conformity"); and
(b) it is accompanied by information on its use in the Czech language in accordance with this Regulation.
(2) Post-marketing diagnostic medical devices are monitored by the State Institute for Drug Control (hereinafter referred to as the Institute) in terms of their safety and quality in accordance with the Health Devices Act.
(3) The provisions of paragraphs 1 to 2 shall also apply to in vitro diagnostic medical devices provided for the performance assessment of laboratories or other persons meeting the requirements laid down in § 4 (5) and Annex 8 to this Regulation.
Common technical specifications
(1) The common technical specifications provide for:
(a) criteria for evaluating and reassessing the performance of in vitro diagnostic medical devices, conditions for releasing production batches;
(b) reference methodologies and reference materials;
the in vitro diagnostic medical devices referred to in point 1 of Annex 2 to this Regulation and, where necessary, in vitro diagnostic medical devices referred to in point 2 of Annex 2 to this Regulation.
(2) The common technical specifications may, where justified, be replaced in the design and manufacture of in vitro diagnostic medical devices by other solutions achieving at least the same level of safety and quality of in vitro diagnostic medical devices.
(3) The common technical specifications are set out in the European Commission Decision on common technical specifications for in vitro5 diagnostic medical devices.
Notified person
(1) The requirements set out in Annex 9 to this Regulation shall apply to the authorisation of legal persons under the Act on Technical Requirements for Products. Legal persons meeting the criteria laid down in the relevant harmonised standards shall be deemed to comply with the relevant minimum criteria necessary for the assignment of the notified person.
(2) The amended person and the manufacturer or his authorised representative shall, by agreement, set the deadlines for the completion of the evaluation and verification activities referred to in Annexes 3 to 7 to this Regulation.
(3) Where the notified person finds that the manufacturer has not complied with or no longer meets the relevant requirements of this Regulation, or where the certificate should not have been issued, the notified person shall suspend, withdraw or restrict the use of the certificate which he has issued, except where the manufacturer has ensured compliance with those requirements by introducing appropriate corrective measures. In the event of suspension, withdrawal or any restriction of the certificate or where action by the Technical Standardisation, Metrology and State Testing Office (hereinafter "the Office ') may be necessary, the notified person shall inform the Office accordingly. The Authority shall inform the other Member States and the Commission.
(4) The nominee shall inform the Office of all certificates issued, modified, supplemented, suspended, withdrawn or refused and shall also inform other persons notified of the certificates suspended, withdrawn or refused and, on request, of certificates issued or refused. The notified person shall also make available on request any other relevant information on certificates issued.
(5) On request, the person nominated shall provide the Office with all relevant information and documents, including budgetary documents enabling verification of compliance with the criteria set out in Annex 9 to this Regulation.
Transitional provisions
(1) In vitro diagnostic medical devices placed on the market before the date of entry into force of this Regulation under existing legislation are considered as in vitro diagnostic medical devices placed on the market in accordance with this Regulation.
(2) Authorised and notified persons responsible for conformity assessment activities pursuant to Government Regulation No 453 / 2004 Coll., as amended, shall be deemed to be authorised and notified persons responsible for conformity assessment activities under this Regulation.
Efficacy
This Regulation shall take effect on 1 April 2015.
Prime Minister:
Sobotka v. r.
Minister for Health:
MUDr.
Příloha č. 1
Annex No 1 to Government Regulation No 56 / 2015 Coll.
Essential requirements
I.
General requirements
1. In vitro diagnostic medical devices shall be designed and manufactured in such a way that, when used under the specified conditions and for the intended purpose, they do not endanger, directly or indirectly, the clinical condition or safety of patients, the safety or health of users or, where appropriate, other persons, or the safety of property. Any risks that may arise from its use must be acceptable in relation to the benefit it presents to patients and must correspond to a high level of health and safety.
2. The solution chosen by the manufacturer for the design of the in vitro diagnostic medical device shall be based on the state of science and technology corresponding to the time the in vitro diagnostic medical device was manufactured. When selecting the most appropriate solution, the manufacturer shall comply with the following principles in order:
2.1. Eliminate or reduce as far as possible risks by safe design and construction;
2.2 take appropriate protective measures against risks that cannot be excluded,
2.3. Inform users of the persistence of risks due to imperfections of the safeguards implemented.
3. In vitro diagnostic medical devices shall be designed and manufactured in such a way as to be suitable for the purposes specified in the Law on Medical Devices in accordance with the manufacturer's specification, taking into account the generally known state of science and technology.
4. The in vitro diagnostic medical device shall achieve the performance established 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 mutual interference, interference, 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 reference materials.
5. The in vitro diagnostic medical device, which may occur under normal operating conditions, shall not be adversely affected by its performance and performance as specified in paragraphs 1 to 4 of this Annex to the extent that the health or safety of the patient or user or, where applicable, of other persons may be compromised during the life of the in vitro diagnostic medical device specified by the manufacturer. If the shelf life or life of an in vitro diagnostic medical device is not established, the same shall apply to the sufficiently predictable shelf life or life of an in vitro diagnostic medical device of this type with regard to its intended purpose and intended use.
6. The in vitro diagnostic medical device shall be designed, manufactured and packaged in such a way that its characteristics and performance at the intended purpose of use are not adversely affected by storage or transport conditions, while maintaining the instructions or information specified by the manufacturer.
II.
Design and production requirements
7.
Chemical and physical characteristics
7.1. In vitro diagnostic medical devices shall be designed and manufactured in such a way as to ensure the characteristics and performance of the requirements of this Annex. Particular attention should be paid to the possibility of reducing analytical performance due to mutual incompatibility between the materials used and the samples such as biological tissues, cells and micro-organisms intended for use together with in vitro diagnostic medical devices for their intended purpose.
7.2. The in vitro diagnostic medical device shall be designed, manufactured and packaged in such a way as to minimise the risks of leakage of fluid from the product, contamination from the contaminated product and other pollutants during storage, transport and use of the in vitro diagnostic medical device, while complying with the manufacturer's instructions.
8.
Infections and microbial contamination
8.1. In vitro diagnostic medical devices and manufacturing processes related thereto shall be designed in such a way as to eliminate or reduce the risk of infection of the user or other persons 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.
8.2. If a diagnostic medical device contains in vitro biological agents, the risk of infection should be minimised by selecting an appropriate donor and the corresponding substances and by using appropriate validated inactivation, preservation, test and management procedures.
8.3. In vitro diagnostic medical devices marked either as "STERILE '(" sterile') or as in vitro diagnostic medical devices in a specific microbiological state, shall be designed, manufactured and packaged in an appropriate packaging in accordance with procedures ensuring that the storage and transport conditions laid down by the manufacturer remain intact or open to the protective packaging in a microbiological state corresponding to the labelling indicated on the in vitro diagnostic medical device when it is placed on the market.
8.4. In vitro diagnostic medical devices marked either as "STERILE '(" sterile') or as in vitro diagnostic medical devices in a specific microbiological state shall be processed by an appropriate validated method.
8.5. In vitro diagnostic medical device packaging systems other than those referred to in section 8.3 shall maintain in vitro diagnostic medical devices without deterioration of the degree of purity indicated by the manufacturer and, if the in vitro diagnostic medical device is sterilised before use, the system shall minimise the possible risk of microbial contamination. In addition, measures should be taken to reduce as far as possible the possibility of microbial pollution in the selection and handling of raw materials, in the production, storage and distribution of materials, in case the functional capacity of an in vitro diagnostic medical device could be affected by such pollution.
8.6. In vitro diagnostic medical devices to be sterilised must be produced under appropriate controlled conditions.
8.7. Packaging systems for non-sterile in vitro diagnostic medical devices shall keep in vitro diagnostic medical devices without deterioration of quality at a specified level of purity and, if the in vitro diagnostic medical devices are intended for sterilisation before use, minimise the risk of microbial contamination. The packaging system shall be suitable for the sterilisation method specified by the manufacturer.
9.
Characteristics in relation to production and environment
9.1. When an in vitro diagnostic medical device is intended for use in combination with other medical devices or equipment, the whole combination, including the interconnector system, shall be safe and shall not interfere with the established functional capability of the in vitro diagnostic medical device. Any restriction of use shall be indicated on the marking, where appropriate, in the instructions for use.
9.2. In vitro diagnostic medical devices shall be designed and manufactured in such a way that the risks associated with their use in the presence of materials, substances and gases with which they may come into contact under normal conditions of use are minimised as far as possible.
9.3. In vitro diagnostic medical devices are designed and manufactured to minimise risk
9.3.1. injury resulting from the physical properties of an in vitro diagnostic medical device,
9.3.2. associated with sufficiently predictable external influences such as magnetic fields, external electrical influences, electrostatic discharges, pressure and humidity, temperature or changes in pressure or acceleration or accidental intrusion of substances into a diagnostic medical device in vitro; an in vitro diagnostic medical device is designed and manufactured to provide sufficient internal resistance to electromagnetic interference to enable its function to the intended purpose.
9.4. In vitro diagnostic medical devices are designed and manufactured in such a way that the risks of fire or explosion are reduced as far as possible during normal operation and even if one defect occurs. Particular attention shall be paid to in vitro diagnostic medical devices for which flammable substances or substances likely to cause ignition are present for the intended purpose.
9.5. In vitro diagnostic medical devices are designed and manufactured in such a way as to allow management of safe disposal of waste.
9.6. The scales for measuring, monitoring or displaying, including colour change and other optical indicators, are designed and manufactured in accordance with ergonomic principles taking into account the intended purpose of the in vitro diagnostic medical device.
10.
Measurement functions
10.1. The in vitro diagnostic medical device, which is an instrument or apparatus with a primary analytical measurement function, shall be designed and manufactured in such a way as to provide sufficient stability and accuracy of measurements within the appropriate accuracy limits, taking into account the intended purpose and taking into account available and appropriate measurement methods and materials. The accuracy limits are specified by the manufacturer.
10.2. If values are expressed numerically, they should be reported in legal units in accordance with the Metrology Act (6).
11.
Radiation protection
11.1. In vitro diagnostic medical devices are designed, manufactured and packaged to minimise exposure to radiation emitted by users and others.
11.2. Where an in vitro diagnostic medical device is intended to emit potentially hazardous visible or invisible radiation, it shall be the highest possible level of
11.2.1. designed and constructed in such a way as to ensure that the characteristics and quantities of radiation emitted can be controlled and, where appropriate, adjusted,
11.2.2. provided with a visual or, where appropriate, audible warning of such emissions.
11.3. The in vitro emission-emitting diagnostic medical device operating instructions shall contain detailed information on the nature of the in vitro diagnostic medical device emitted, the user protection information and ways to avoid misuse and the risks arising from installation.
12.
Electrical safety and electromagnetic compatibility
12.1. In vitro diagnostic medical devices containing electronic programmable systems, including software, are designed to ensure the repeatability, reliability and functionality of the system according to its intended purpose.
12.2. In vitro diagnostic medical devices are designed and manufactured in such a way as to minimise the risk of electromagnetic interference which could affect the operation of another medical device or device in the normal environment.
12.3. The in vitro diagnostic medical device is designed and manufactured in such a way that, provided it is correctly installed, the risk of accidental electric shock is eliminated as far as possible in normal use as well as in the event of one defect.
13.
Protection against mechanical and thermal risks
13.1. The in vitro diagnostic medical device is designed and manufactured to guarantee the protection of the user against mechanical risks. The in vitro diagnostic medical device is sufficiently stable under foreseeable operating conditions. It shall be able to withstand the stress of the expected operating environment and shall retain this resistance for its intended service life if all the control and maintenance requirements specified by the manufacturer are complied with. Where risks exist with regard to the presence of moving parts, breaking or disconnection or leakage of substances, appropriate protective measures shall be included. All covers or other protective mechanisms included in the in vitro diagnostic medical device for protection, especially against moving parts, shall be safe and shall not impede access to the in vitro diagnostic medical device in normal operation or restrict the regular maintenance of the device as specified by the manufacturer.
13.2. The in vitro diagnostic medical device shall be designed and manufactured in such a way as to minimise the risk of vibration caused by this in vitro diagnostic medical device, taking into account technical progress and the available possibilities to reduce such vibration, in particular at their source, unless such vibration is a specific part of the in vitro diagnostic medical device's performance.
13.3. The in vitro diagnostic medical device shall be designed and manufactured in such a way as to minimise the risk arising from the noise it emits, taking into account technical progress and the available possibilities to reduce noise, in particular at its source, if the noise emitted is not a specific part of the functional competence of the in vitro diagnostic medical device.
13.4. The end and connection parts to electrical, gas or hydraulic and pneumatic energy sources to be handled by the user are designed and constructed to minimise all possible risks.
13.5. Accessible parts of an in vitro diagnostic medical device, except for those parts or places intended to supply heat or to reach specified temperatures and their surroundings, shall not reach potentially hazardous temperatures under normal conditions of use.
14.
In vitro diagnostic medical devices for self-testing
14.1. The in vitro diagnostic medical device for self-testing shall be designed and manufactured in such a way that its activity is consistent with the intended purpose, taking into account the expertise and available means of users and the influence caused by variations that can be expected in user technical procedures and environments. The information and instructions provided by the manufacturer should be easy to understand and easy to use for users.
14.2. In vitro diagnostic medical devices for self-testing are designed and manufactured to:
14.2.1. is easy to use for users; and
14.2.2. reduce the risk of user error when handling and interpreting results to the lowest extent.
14.3. The in vitro diagnostic medical device must, where possible, include a user inspection, a procedure whereby the user can satisfy himself that during the period of use the in vitro diagnostic medical device will be fit for self-testing in accordance with the intended purpose.
15.
Information provided by the manufacturer
15.1. Each in vitro diagnostic medical device shall be provided with the information necessary for its safe and proper use, taking into account the training and knowledge of potential users, and the identification of the manufacturer. Such information shall be understood as labelling and instructions for use. Where practicable and appropriate, the information necessary for the safe use of the in vitro diagnostic medical device shall be indicated on the in vitro diagnostic medical device itself or, where applicable, on the sales packaging. Where the complete labelling of each unit of an in vitro diagnostic medical device is practically not feasible, the information shall be provided on the packaging or, where appropriate, in the instructions for use provided with one or more in vitro diagnostic medical devices.
15.2. Instructions for use shall be provided to the user or accompanied by an in vitro diagnostic medical device or accompanied by a package of one or more in vitro diagnostic medical devices.
15.3. In duly justified and exceptional cases, instructions for use for in vitro diagnostic medical devices are not required if in vitro diagnostic medical devices can be properly and safely used without them.
15.4. Where appropriate, information shall take the form of symbols. Each symbol and identification colour used shall comply with harmonised standards. In areas for which harmonised standards do not exist, the symbols and colour used shall be described in the accompanying documentation for the in vitro diagnostic medical device.
15.5. In the case of an in vitro diagnostic medical device containing a substance which may be considered dangerous in view of the characteristics and quantities of its constituents and forms in which it is present, appropriate warning symbols shall be used and the labelling requirements laid down in the relevant regulations shall be met.
15.6. In cases where, for lack of space, the whole information cannot be connected to the in vitro diagnostic medical device itself or on its label, warning symbols shall be placed on the label and the other information required by this Regulation shall be indicated in the instructions for use.
15.7. The marking shall contain the following details which may, where appropriate, be in the form of symbols:
15.7.1. the name or business name and address of the head office or, where applicable, the address of the main business establishment, where the manufacturer is a natural person; the name or business name and address of the registered office if the manufacturer is a legal person (hereinafter referred to as "identification data '). In the case of in vitro diagnostic medical devices imported into Member States with a view to their distribution in the European Union, the labelling, outer packaging or instructions for use shall include the identification details of the authorised representative,
15.7.2. the details necessary for users to clearly identify the in vitro diagnostic medical device and the contents of the package,
15.7.3. the inscription "STERILE" ("sterile"), when it comes to a sterile diagnostic medical device in vitro or a declaration showing any particular microbiological condition or degree of purity;
15.7.4. the production batch code ("lot") preceded by the symbol "LOT" or serial number,
15.7.5. If necessary, the date by which the in vitro diagnostic medical device or part thereof should be safely used without deterioration of the performance expressed in the following order: year, month and, where applicable, date,
15.7.6. in the case of a medical device intended for the assessment of performance, the words "performance only,"
15.7.7. where appropriate, a statement indicating that an in vitro diagnostic medical device is intended for in vitro use,
15.7.8. Special storage conditions and handling conditions, if any,
15.7.9. special operating instructions, if necessary;
15.7.10. Appropriate warnings, if any, of the necessary safety measures,
15.7.11. where an in vitro diagnostic medical device is intended for self-testing, this shall be clearly stated.
15.8. If the intended purpose of the user is not obvious, the manufacturer shall indicate that purpose in the instructions for use and on the indication of the in vitro diagnostic medical device, where appropriate.
15.9. Where appropriate and practical, in vitro diagnostic medical devices and separate components shall be identified as appropriate with batch data in order to take appropriate steps to identify the risks posed by these in vitro diagnostic medical devices and their separable components.
15.10. The instructions for use, unless excluded by the nature of the in vitro diagnostic medical device, shall include the following details:
15.10.1. listed in sections 15.7.4 and 15.7.5.
15.10.2. on the composition of the reagent reaction result according to the nature and quantity or concentration of the active ingredient (s), reagent (s) or reagent (s), and where it is considered that the in vitro diagnostic medical device contains other components which may affect the measurement,
15.10.3. the conditions and storage period after first opening of the primary packaging, together with storage conditions and stability of the working agents,
15.10.4 on the performance referred to in point 4 of this Annex,
15.10.5. concerning all necessary equipment, including information needed to identify such equipment for proper use;
15.10.6. on the type of sample planned for use, special conditions for collection, preparation procedure and, if necessary, storage conditions, including instructions for patient preparation,
15.10.7. The procedure to be followed when using an in vitro diagnostic medical device,
15.10.8. on the measurement procedure to be followed for in vitro diagnostic medical devices and, where appropriate,
15.10.8.1. to the nature of the procedure,
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Government Regulation No. 56 / 2015 Coll., on technical requirements for in vitro diagnostic medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.03.2015 |
|---|---|
| Effective from | 01.04.2015 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0