Government Regulation No. 54 / 2015 Coll.
Government Regulation on Technical Requirements for Medical Devices
Valid
Regulation
Effective from 01.04.2015
Text versions:
01.04.2015
31.03.2015
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54
GOVERNMENT REGULATION
of 25 March 2015
on technical requirements for 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 Acts, as amended by Act No. 71 / 2000 Coll., Act No. 205 / 2002 Coll., Act No. 34 / 2011 Coll., Act No. 100 / 2013 Coll. and Act No. 64 / 2014 Coll., hereinafter referred to as "Act on Technical Requirements for Products" (hereinafter referred to as "Act on Medical Devices") to implement § 2 (d), § 11 (1) Coll., on Administrative Charges, as amended, (hereinafter referred to as "Act on Medical Devices") to implement § 5 (1) and § 6 (a) of the Act on Medical Devices:
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 Article 12 (1) (a) of the Act on Technical Requirements for Products of Medical Devices and Accessories.
(3) This Regulation shall not apply to:
(a) in vitro diagnostic medical devices and accessories thereof,
(b) active implantable medical devices.
Definition of terms
For the purposes of this Regulation:
(a) a subgroup of medical devices a set of medical devices having common areas of intended purpose or common technology;
(b) a group of generic medical devices which have the same or similar intended purpose or common technology, allowing them to be classified generically without taking into account the characteristics of a particular medical device.
General principles
(1) A medical device shall comply with the essential requirements set out in Annex 1 to this Regulation (hereinafter referred to as "the essential requirements') applicable to a particular medical device, taking into account its intended purpose.
(2) Where medical devices are also affected by other legislation governing technical requirements for personal protective equipment (2) and ionising radiation3), the application of this legislation shall not be affected by this Regulation. The essential requirements in terms of electromagnetic compatibility shall be specified for medical devices in Annex 1 to this Regulation and the Government Regulation laying down technical requirements for products with regard to their electromagnetic compatibility 4 shall not apply in their assessment.
(3) Where there is an appropriate risk, a medical device, which is also machinery, must also comply with the essential health and safety requirements laid down in the Government Regulation on technical requirements for machinery (5), provided that the essential requirements set out therein are more specific than those laid down in this Regulation.
(4) The essential requirements shall be deemed to be met if the medical device complies with the requirements of the harmonised norem6) which relate to that medical device taking into account its intended purpose. For the purposes of this Regulation, the reference to harmonised standards shall also include the monographs of the European Pharmacopoeia, in particular on surgical suture material and the interaction between medicinal products and materials used in medical devices containing those medicinal products, to which references have been published in the Official Journal of the European Union.
Conformity assessment procedures
(1) In the case of a Class I medical device which is not an individually manufactured medical device or a medical device intended for a clinical trial, the manufacturer shall follow the CE marking for its action in accordance with the procedure set out in Annex 7 to this Regulation.
(2) In the case of a Class IIa medical device which is not an individually manufactured medical device or a medical device intended for a clinical trial, the manufacturer shall follow the CE marking for its action in accordance with the procedure laid down in Annex 7 to this Regulation in conjunction with the procedure laid down in:
(a) Annex 4 to this Regulation;
(b) Annex 5 to this Regulation; or
(c) Annex 6 to this Regulation.
Instead of the procedures referred to in points (a) to (c), the procedure referred to in paragraph 3 (a) may be used.
(3) In the case of a medical device of hazard class IIb which is not an individually manufactured medical device or a medical device intended for a clinical trial, the manufacturer shall, for its action, follow the procedure laid down in:
(a) Annex 2 to this Regulation, with the exception of points 8, 9 and 10; or
(b) in accordance with the procedure laid down in Annex 3 to this Regulation, in conjunction with Annex 4, 5 or 6 to this Regulation.
(4) In the case of a Class III medical device which is not a individually manufactured medical device or a medical device intended for a clinical trial, the manufacturer shall follow the CE marking for its action in accordance with the procedure laid down in:
(a) Annex No 2 to this Regulation; or
(b) Annex 3 to this Regulation, in conjunction with the procedure laid down in Annex 4 or Annex 5 to this Regulation.
(5) Before placing on the market or putting into service any individually manufactured medical device, the manufacturer shall, in accordance with Annex 8 to this Regulation.
(6) 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 the Czech Republic of an individual medical device for which the procedure referred to in paragraphs 1 to 5 has not been carried out and the use of which is in the interest of health protection.
(7) When assessing the conformity of a 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.
(8) At the manufacturer's direction, the authorised representative shall be entitled to initiate the procedure laid down in Annexes 3, 4, 7 and 8 to this Regulation.
(9) Where the conformity assessment procedure for a medical device involves the participation of a notified person, the manufacturer or his authorised representative shall request the assessment of the conformity of the notified person of his choice with an appropriate scope of authorisation and notification.
(10) 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.
(11) Certificates issued by the notified person and other decisions made by the notified person in accordance with Annexes 2, 3, 5 and 6 to this Regulation shall be valid for a maximum period of five years and may be extended for a further period of up to five years, on the basis of a request submitted at the time agreed by both Parties in a contract signed by both Parties.
(12) The accompanying and manufacturing documentation of the medical device, records and correspondence relating to the procedures referred to in Section 4 are kept in the Czech language and, where appropriate, in another language approved by the notified person.
(13) The conformity assessment procedures for minimising the risk of transmission of transmissible spongiform encephalopathy (TSE) to humans shall be governed by Commission Regulation (EC) No 722 / 2012 on specific requirements relating to the requirements laid down in Council Directives 90 / 385 / EEC and 93 / 42 / EEC with regard to active implantable medical devices and medical devices manufactured using tissues of animal origin, as amended.
Specific procedure for medical devices systems and kits and for sterilisation
(1) Paragraph 4 does not apply to systems and sets of medical devices, unless otherwise specified.
(2) Any natural or legal person who completes medical devices bearing the CE marking with a view to placing them on the market as a system or kit in accordance with the intended purpose shall draw up a declaration stating that:
(a) verify the compatibility of medical devices with the instructions of their manufacturers and ensure that they are operated in accordance with those instructions;
(b) package the system or kit of medical devices and attach appropriate information to it for users, including instructions from manufacturers of individual medical devices; and
(c) all activities comply with the relevant internal control and inspection methods.
(3) If the requirements referred to in paragraph 2 are not met, such a system or set of medical devices shall be considered as a medical device subject to the procedure laid down in Article 4.
(4) Any natural or legal person who sterilises the systems and sets of medical devices referred to in paragraph 2 or other CE-marked medical devices intended for sterilisation by their manufacturers before use, in order to place them on the market, shall choose one of the procedures set out in Annex 2 or Annex 5 to this Regulation. The use of these annexes and the activity of the notified person shall be limited to verifying the process used to achieve sterility lasting until the time of opening or damaging the sterile packaging. The person concerned shall draw up a declaration certifying that the sterilisation has been carried out in accordance with the manufacturer's instructions.
(5) The medical devices referred to in paragraphs 2 and 4 may not be affixed with an additional CE marking, but shall be accompanied by information in accordance with points 16 and 17 of Annex 1 to this Regulation containing the relevant data of manufacturers of complete medical devices. The declarations referred to in paragraphs 2 and 4 shall be kept for at least 5 years at the disposal of the competent administrative authorities.
CE marking
(1) A medical device, with the exception of an individually manufactured medical device and a medical device intended for a clinical trial which complies with the requirements laid down in this Regulation, shall be affixed to the CE marking, the graphic form of which is laid down in the directly applicable European Union7) before being placed on the market or put into service.
(2) Where a medical device is subject, in other respects, to specific legislation which establishes an obligation to affix it to the CE marking, it shall in such a case state that the 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 product concerned 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.
(4) The CE marking shall be placed visibly, legibly and indelibly on the medical device or its sterile packaging, where practicable and appropriate, and in the instructions for use. Where possible, the CE marking shall also be placed on the packaging of the 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 2, 4, 5 and 6 to this Regulation.
(6) A different character may be placed on the medical device, its packaging or in the instructions accompanying the medical device, provided that it does not reduce the visibility or legibility of the CE marking. No marks and inscriptions likely to mislead third parties as regards the meaning and shape of the CE marking may be affixed to the medical device.
(7) A medical device which does not bear the CE marking or does not comply with the requirements of this Regulation or the Law on Medical Devices may be displayed at trade 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.
Placing on the market and putting into service
(1) A medical device may be placed on the market or put into service if:
(a) the conformity of its characteristics with 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, if correctly installed, maintained and used in accordance with its intended purpose, bears the CE marking, meets the additional requirements set out in paragraphs 1 to 3 of Section 3, 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) A medical device intended for clinical trials may only be made available to persons conducting a clinical trial if the conditions laid down in the Health Devices Act and Annex 8 to this Regulation are met.
(3) An individual-made medical device may be placed on the market or put into service if it has been assessed as conformity in accordance with Annex 8 and the individual-made medical device has been accompanied by a declaration in accordance with that Annex, which is available to a particular patient.
(4) The medical device intended for clinical trials and the individually manufactured medical device shall not bear the CE marking.
Notified person
(1) The requirements set out in Annex 10 to this Regulation shall apply to the authorisation of legal persons under the Technical Requirements Act on 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 2 to 6 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 of the European Union, the Contracting States to the Agreement on the European Economic Area, Switzerland and Turkey (hereinafter referred to as" the Member State') and the European Commission.
(4) The amended person shall inform the Office of any issued, modified, supplemented, suspended, withdrawn or refused certificates and shall also inform other persons notified of suspended, withdrawn or refused certificates and of certificates issued on request. 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 10 to this Regulation.
Transitional provisions
(1) A medical device placed on the market before the date of entry into force of this Regulation under existing legislation shall be considered as a medical device placed on the market in accordance with this Regulation.
(2) Authorised and notified persons responsible for conformity assessment activities under Government Regulation No 336 / 2004 Coll., as amended, shall be deemed to be authorised and notified persons 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 54 / 2015 Coll.
Essential requirements
I.
General requirements
1. A medical device shall be designed and manufactured in such a way that, when used under the conditions and for the intended purpose, it does not jeopardise the clinical condition or safety of patients, nor the safety and health of users or, where appropriate, other persons, provided that any risks which may be associated with the intended purpose of the medical device are acceptable in relation to its benefit to the patient and the medical device corresponds to a high level of health and safety. This includes:
1. 1. the reduction, where possible, the risk of error in use due to the ergonomic properties of the medical device and the environment in which the medical device may be used; and
1. 2. an assessment of the technical knowledge, experience, education and training of users and, where appropriate, the health and physical condition of the users for which the medical device is intended.
2. The solutions chosen by the manufacturer in the design and construction of the medical device shall comply with the principles of safety and the current level of science and technology. When selecting the most suitable solutions, the manufacturer shall base the following principles in the following order:
2. 1. to exclude or at least minimise any risks by the safe design and design of a medical device;
2. 2. to take, where appropriate, appropriate protective measures including, where appropriate, warnings against hazards which cannot be excluded,
2. 3. inform users of the persistence of risks due to the lack of full perfection of the protective measures implemented.
3. The medical device shall be functional as specified by the manufacturer and shall be designed, manufactured and packaged in such a way that it is suitable for one or more purposes meeting the definition of medical device under the Health Device Act and in accordance with the manufacturer's specifications.
4. In the case of a medical device which may occur under normal operating conditions, there shall be no adverse effect on its characteristics and performance as referred to in paragraphs 1, 2 and 3 of this Annex to the extent that the health or safety of the patient or user or, where applicable, on other persons, during the life of the medical device specified by the manufacturer, if the manufacturer has determined this period.
5. The medical device shall be designed, manufactured and packaged in such a way that, under the conditions laid down by the manufacturer for its storage and transport, such as temperature or humidity in particular, its characteristics and performance cannot be adversely affected.
6. Any side effect of a medical device may pose only an acceptable risk compared to the intended effects of a medical device.
7. The demonstration of compliance with the essential requirements shall include a clinical evaluation under the Medical Devices Act.
II.
Design and construction requirements
8.
Chemical, physical and biological characteristics
8.1. The medical device shall be designed and manufactured in such a way as to guarantee the characteristics and performance of the general requirements. Particular attention should be paid to:
8. 1. 1. Selection of materials intended for the manufacture and packaging of medical devices, in particular in terms of toxicity and, where appropriate, flammable substances,
8.1.2. mutual compatibility between the materials used and the biological tissues, cells and body fluids, taking into account the intended purpose; and
8.
8.2. The medical device shall be designed, manufactured and packaged in such a way as to minimise the risk of pollution caused by undesirable substances and radiation constituents and their residues against users and persons involved in the transport, storage and use of the medical device in accordance with its intended purpose. Particular attention should be paid to the effect on the tissue, time and frequency of this action.
8.3. The medical device shall be designed, manufactured and packaged in such a way that it can be safely used together with the substances and gases it comes into contact with during normal use and normal procedures.
8.4. Where a medical device is intended for the administration of medicinal products, it shall be designed and manufactured in such a way that, for the intended purpose, it is compatible with those medicinal products within the limits of the provisions and restrictions governing the medical device and in order to maintain its functional capacity in accordance with the intended purpose.
8.5. Provisions for medical devices with an integrated medicinal product or a human blood derivative
8. 5. 1. Where a medical device contains, as an integral part of it, a substance which may be considered as a medicinal product when used alone and which may act as an additional effect on the body to the effect of the medical device, the quality, safety and usefulness of that substance shall be verified by analogy using the methods set out in the Drug Act (8).
8.5.2. For the substances referred to in point 8.5.1. of this Annex, the notified person, after verifying the usefulness of the substance as part of a medical device and taking into account the intended purpose of the medical device, shall seek an expert opinion on the quality and safety of the substance, including a clinically verified risk-benefit ratio for the inclusion of the substance in the medical device, from one of the competent authorities of the Member States or from the European Medicines Agency (the Agency). Where a professional opinion is requested by the State Institute for Drug Control (hereinafter referred to as the Institute), it shall take into account the production process and the information on the usefulness of the inclusion of the substance in the medical device, as indicated by the notified person.
8. 5. 3. Where a medical device contains as an integral part of a human blood derivative, the notified person shall, after verifying the usefulness of the human blood derivative as part of the medical device and taking into account the intended purpose of the medical device, request the Agency's expert opinion on the quality and safety of the human blood derivative, including a clinically verified risk-benefit ratio of the incorporation of the human blood derivative into the medical device.
8. 5. 4. Where changes are made to the complementary substance incorporated into the medical device, in particular as regards its manufacturing process, the notified person shall be informed of the changes, who shall request a professional opinion from the competent authority which issued the original expert opinion to confirm that the quality and safety of the complementary substance is maintained. Where a professional opinion is requested by the Institute, it shall take into account the information on the usefulness of the inclusion of the additional substance in the medical device, as provided by the notified person, in order to ensure that the changes have no negative impact on the clinically verified risk-benefit balance when integrating the additional substance into the medical device.
8. 5. 5. Where the Institute, as the responsible competent authority which issued the original expert opinion, receives information on the additional substance which could have an impact on the clinically verified risk-benefit ratio when it is incorporated into a medical device, the notified person shall give an expert opinion as to whether the information has an impact on the established clinically verified risk-benefit ratio for the inclusion of the additional substance in the medical device or not. The notified person shall take into account the updated expert opinion when reassessing his conclusion from the conformity assessment procedure.
8.6. The medical device shall be designed and manufactured in such a way as to minimise the risks caused by substances leaking from the medical device. Particular attention should be paid to substances which are carcinogenic, mutagenic or toxic to reproduction under the Chemicals Act.
8.7. Where parts of a medical device or a medical device as a whole intended for the administration or disposal of medicinal products, body fluids or other substances into or out of the body, or a medical device intended for the transport and storage of such body fluids or other substances, contain phthalates classified as carcinogenic, mutagenic or toxic to reproduction category 1 or 2 under the Chemicals Act, such medical devices shall be identified as a medical device containing phthalates, or, where appropriate, the packaging of each of its pieces, or, where appropriate, its sales packaging. Where the intended purpose of this medical device involves the treatment of children, pregnant or breast-feeding women, the manufacturer shall provide specific justification for the use of such substances in the technical documentation, taking into account compliance with the essential requirements and in the instructions for use, for providing information on residual risks for those user groups and, where possible, on appropriate preventive measures.
8.8. The medical device must be designed and manufactured in such a way that the risks of unintended intrusion into it, taking into account the medical device and the nature of the environment in which it is to be used, are reduced to the minimum possible.
9.
Infections and microbial contamination
9.1. The medical device and its manufacturing processes shall be designed in such a way as to eliminate or minimise the risk of transmission of infection by the medical device to the patient, user and other persons, or contamination by those persons, as far as possible.
9.2. The tissues of animal origin used for the manufacture of the medical device shall come from animals under veterinary supervision to the extent appropriate to the intended purpose of those tissues. Notified persons shall keep information on the geographical origin of these animals.
The processing, storage, testing and handling of tissues, cells and substances of animal origin shall be carried out in such a way as to achieve an optimum level of safety, in particular against contamination of viruses or other agents of infection in the manufacture of a medical device, by introducing validated methods designed to inactivate viruses or remove viruses or other agents of infection.
9.4. The medical device supplied in sterile condition shall be designed, manufactured and packaged in disposable packaging and, where appropriate, appropriate procedures shall ensure that it is sterile when placed on the market and remains sterile under specified storage and transport conditions until the protective packaging is opened or damaged.
9.5. The medical device supplied in sterile condition shall be manufactured and sterilised by the appropriate approved procedure.
9.6. The medical device to be sterilised shall be manufactured under appropriate controlled conditions.
9.7. The packaging systems of the non-sterile medical device shall ensure a specified level of purity of the medical device. If the medical device is to be sterilised before use, the packaging systems must reduce the risk of microbiological contamination to the minimum possible. The packaging systems shall be suitable for the application of the sterilisation method specified by the manufacturer.
9.8. Identical or similar medical devices which are sold in both sterile and non-sterile conditions shall be mutually differentiated by packaging or marking.
10.
Design and characteristics in relation to the environment
10.1. Where a medical device is intended to be used in conjunction with another medical device or equipment, the kit thus created, including the interconnector system, shall be safe and shall not interfere with the specified functional capability of the medical devices. Any restriction on the applicability shall be indicated in the marking of the medical device or in the instructions for use.
10.2. The medical device must be designed and manufactured in such a way as to eliminate or minimise risks
10.2.1. injuries resulting from the physical characteristics of the medical device, including the ratio of volume and pressure, dimensional or ergonomic properties,
10.2.2. associated with reasonably foreseeable ambient conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure, temperature or changes in pressure and acceleration,
10.2.3. interaction with other medical devices commonly used in certain investigations or treatments; and
10. 2. 4. resulting from ageing of the materials used or loss of accuracy of the measuring or control mechanism and from the fact that the medical device cannot be maintained or calibrated (implants).
10.3. The medical device shall be designed and manufactured in such a way as to eliminate or minimise the risk of fire or explosion in normal use even if a single defect occurs. Particular attention should be paid to the medical device intended for use in the environment of flammable substances or substances which may cause combustion.
11.
Measurement functions
11.1. A medical device with a measuring function shall be designed and manufactured in such a way as to provide sufficient accuracy and stability within the specified accuracy limits with regard to its intended purpose. The accuracy limits shall be specified by the manufacturer.
11.2. The scale of measuring instruments and displays shall be dealt with in accordance with ergonomic principles with regard to the intended purpose.
11. 3. The results of measurements carried out by a medical device with a measuring function shall be expressed in legal units according to the legislation governing metrology9).
12.
Radiation protection
12.1. The medical device must be designed and manufactured in such a way that exposure of patients, users and other persons to the effects of radiation is reduced to the lowest possible extent, taking into account the intended purpose, without limiting the use of the necessary levels of radiation for diagnostic and therapeutic purposes.
12.2. Where a medical device is intended to emit radiation at hazardous levels but necessary for a specific medical purpose, the benefit of which is considered appropriate to that risk, the operator shall be able to control the level of such emissions. Such a medical device shall be designed and manufactured in such a way as to guarantee the reproducibility and tolerance of the relevant parameters.
12.3. Where a medical device is intended to emit potentially hazardous radiation, it shall, where possible, be accompanied by visual or audible warnings to alert such emissions.
12.4. The medical device shall be designed and manufactured in such a way that the exposure of patients, users and other persons to accidental or diffuse undesirable radiation is limited to the minimum possible.
12. 5. Instructions and, where appropriate, operational instructions for the use of a radiation-emitting medical device shall include detailed information on the nature of the radiation emitted, the means of protection of the user and the means of preventing the misuse of such radiation and excluding risks arising from the installation of such a medical device.
12.6. A medical device intended to emit ionising radiation shall be designed and manufactured in such a way that, where the intended purpose so permits, the quantity, geometry and quality of the radiation emitted can be changed and controlled.
12.7. A medical device emitting ionising radiation intended for radiodiagnostic purposes shall be designed and manufactured in such a way that the appropriate imaging or output quality for the intended therapeutic purpose is achieved at the lowest possible radiological load of the patient and user or third party, as appropriate.
12.8. A medical device emitting ionising radiation intended for radiotherapy shall be designed and manufactured in such a way that reliable monitoring and management of the supplied dose, the type and energy of the beam of radiation can be made possible and, where necessary, the quality of the radiation.
13.
Electrical safety and electromagnetic compatibility
13.1. A medical device containing electronic programmable systems shall be designed in such a way as to ensure the functional stability, reliability and functionality of such systems in accordance with the intended purpose. If a defect occurs in this system, the resulting risks must be eliminated or reduced to the lowest possible level by an appropriate means.
13.2. In the case of a medical device which contains software or which itself is medical software, the software shall be validated according to the latest knowledge, taking into account the principles of life cycle development, risk management, validation and verification.
13. 3. The medical device for which the patient's safety depends on the internal energy source shall be equipped with a device to determine the state of the energy source.
13. 4. The medical device in which the patient's safety depends on the external energy source shall be equipped with a warning system to signal the failure of the source.
13.5. A medical device intended to monitor one or more clinical data of the patient shall be equipped with appropriate warning systems to report a situation which could result in the patient's death or serious deterioration of his or her health.
14.
14.1. The medical device shall be designed and manufactured in such a way as to minimise the risk of electromagnetic fields occurring which could interfere with the operation of other medical devices or equipment in their normal environment.
14.2. The medical device shall be designed and manufactured in such a way that, provided it is correctly installed and used, the risk of accidental electric shock during normal use and any defect is avoided as far as possible.
14.3. The medical device shall be designed and manufactured in such a way as to guarantee the protection of the patient, user and third party against risks related to mechanical properties, in particular strength, stability and movement of certain parts.
14.4. The medical device shall be designed and manufactured in such a way that, taking into account the current level of science and technology and the available possibilities for limiting vibrations at their source, the hazard arising from vibrations caused by such a medical device is reduced to the lowest possible extent, unless such vibrations are a specific part of the intended purpose.
14.5. The medical device shall be designed and constructed in such a way that, taking into account the current level of science and technology and the available possibilities to reduce noise, in particular at its source, the lowest possible level of danger arising from the noise emitted by it, unless such noise is a specific part of the intended purpose.
15.
15.1. The medical device shall be designed and constructed in such a way as to minimise the risk arising from the end-and-end parts of the medical device to the electrical energy, pressure fluid, air and gas sources with which the user or operating staff must handle.
15.2. The medical device shall be so designed and constructed that its accessible parts and their surroundings, except for those parts or places intended to supply heat or to reach specified temperatures, do not reach potentially hazardous temperatures under normal operating conditions.
15.3. A medical device intended to supply the patient with energy or substances shall be designed and manufactured in such a way that the quantity supplied can be regulated with an accuracy that guarantees the safety of the patient and user.
15.4. A medical device intended to supply energy or substances to the patient shall be equipped with a device indicating or preventing the supply of an excessive amount of energy or substances which could be dangerous. The medical device shall be equipped with an appropriate device capable of preventing, as far as possible, the accidental release of dangerous quantities of energy or substances from its sources.
15. 5. The medical device shall clearly indicate the functions of controls and indicators. If the instructions necessary for its operation are located on the medical device or indicating operating or setting parameters using the visual system, this information shall be understood by the user and, where appropriate, the patient.
Information provided by the manufacturer
16.
16.1. Each 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, where appropriate, operators and the identification of the manufacturer. Such information shall be understood as labelling and instructions for use.
16.2. Where practicable and appropriate, the information referred to in point 16.1. of this Annex shall be indicated on the medical device itself, on the packaging of each of its pieces and, where appropriate, on the packaging in which it is sold. If unit packaging is not feasible, the information shall be included in the instructions for use supplied with one or more medical devices.
4.3. Each medical device must be packed with instructions for its use; This does not apply to a medical device of hazard class I or IIa if instructions for use are not needed for its safe use.
4.4. If it is appropriate that the information referred to in paragraph 16.1. be in the form of symbols, the symbol (s) used or the identification colour shall comply with the harmonised standards. In areas where no harmonised standards exist, symbols and colours shall be described in the documentation supplied with the medical device.
17.
17.
17.1.1. the name or business name and address of the registered office if the manufacturer is a legal person; the name or business name and its registered office or, where applicable, the address of its principal business establishment or, where applicable, the address of residence, if the manufacturer is a natural person; in the case of medical devices imported into Member States of the European Union, provided that they are distributed within the European Union, the marking, outer packaging or instructions for use shall in addition include the name or name or business name and address of the place of business or registered office of the authorised representative, if the manufacturer is not established in a Member State;
17. 1. 2. the details of the user's essential needs to identify the medical device and the contents of the package,
17. 1. 3. the inscription "STERILE" ("sterile"), if it is a sterile medical device,
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Regulation Information
| Citation | Government Regulation No. 54 / 2015 Coll., on Technical Requirements for 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.
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