Government Decree No. 180 / 1998 Coll.
Government Regulation laying down technical requirements for medical devices
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Regulation
Effective from 01.10.1998
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180
GOVERNMENT REGULATION
of 10 June 1998
laying down technical requirements for medical devices
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts (hereinafter referred to as "the Act") to implement Sections 12 (1) and (4) and 13 (2) and (4) of the Act:
Preliminary provisions
(1) For the purposes of this Regulation, a medical device (hereinafter referred to as "medical device ') means any instrument, apparatus, device, device, material or other article or product, used either separately or in combination, including the necessary software intended for human use by the manufacturer or importer, for the purpose of:
(a) diagnosis, prevention, monitoring, treatment or mitigation of the disease;
(b) diagnosis, monitoring, treatment, mitigation or compensation of injury or disability;
(c) investigation, replacement or modification of the anatomical structure or physiological process;
(d) checks on conception;
and which does not achieve its main intended function in or on the human body by pharmacological, immunological or metabolic action, but whose function may be supported by such effects.
(2) A medical device shall also be considered as:
(a) a product intended for the administration of a medicinal product; (1) if such a medical device is placed on the market in such a way that the medical device and the medicinal product are the only integral product intended solely for use in this combination and not for repeated use, it shall be subject only to the safety and efficacy characteristics listed in Annex I to this Regulation;
(b) a product which contains as an integral part a substance which, when used separately, can be considered as a medicinal product and which acts on the body with an effect complementary to that of the medical device;
(c) a product or article which is not a medical device referred to in paragraph 1 but is intended by the manufacturer specifically for use together with the medical device in such a way as to enable it to be used in accordance with the purpose specified by the manufacturer ("accessories").
(3) The designated products under Section 12 (1) of the Act are medical devices.
This Regulation shall not apply to:
(a) medical devices which are a reagent, a result of reaction, calibrators, control materials, orchards, instruments, apparatus, devices or systems used alone or in combination intended by the manufacturer for the use of "in vitro" samples, including donated blood and tissues derived from the human body, in order to obtain information on physiological or pathological status, or on congenital anomalies, or for the determination of safety and compatibility with potential recipients or for the monitoring of therapeutic measures; sample vessels intended by the manufacturer for use in in vitro diagnostic testing shall be considered as such;
(b) medical devices whose activity depends on a source of electrical or other energy, which is not produced directly by the human body or gravity, intended for the complete or partial introduction of medically into the human body, while remaining at the place of introduction (hereinafter referred to as "active implantable medical devices"), unless otherwise provided for in specific legislation;
(c) cosmetic products;
(d) products containing human blood, human blood products, human plasma or blood cells of human origin at the time of their placing on the market;
(e) transplants, tissues or cells of human origin and products containing or derived from them;
(f) transplants, tissues or cells of animal origin, with the exception of medical devices manufactured using inanimate or dead animal tissue or inanimate products derived from animal tissue;
(g) personal protective equipment covered by a separate Regulation (2)
For the purposes of this Regulation, the following definitions shall also apply:
(a) by the manufacturer, the natural or legal person responsible for the design, manufacture, packaging and labelling of the medical device before being placed on the market under his own name, whether or not those activities are carried out by a third party. The obligations of the manufacturer under this Regulation shall also apply to a natural or legal person who compiles, packs, processes, modifies or identifies a medical device with the intention of placing it on the market under his name; the preceding part of this sentence does not apply to a natural or legal person who is not a manufacturer and who compiles or modifies a medical device which is already on the market for use by a natural person and for the purpose specified by the manufacturer, the importer or, where applicable, the person referred to in the part of that sentence in front of the semicolon (hereinafter referred to as "intended purpose of use '),
(b) a user-sick natural person (hereinafter referred to as "patient"), a natural or legal person providing health care or other persons using a medical device for the intended purpose;
(c) putting into service the period during which the medical device is made available to the user as a product which is first prepared for the intended purpose of use;
(d) a custom medical device manufactured individually in accordance with a prescription by which a doctor issues, under his responsibility, an individual design of the characteristics of a medical device intended for the sole use of a particular user. However, a mass-produced medical device treated at the request of a doctor shall not be regarded as a custom medical device,
(e) a medical device intended for clinical evaluation by a medical device designated by the manufacturer or importer to be used by the healthcare worker (4) in an appropriate clinical environment; the category and field of this health care professional must correspond to the assessed medical device and the state of health of the natural person to whom the clinical trial is conducted.
General principles
(1) The designated products under Section 12 (1) of the Act are medical devices.
(2) The medical device shall comply with the essential requirements set out in Annex I to this Regulation (hereinafter referred to as "the essential requirements'), taking into account the intended purpose of use.
(3) A medical device may be put into service if it complies with the requirements referred to in paragraph 1 and is properly installed in accordance with its intended use.
Labelling of medical devices Czech mark of conformity
(1) The Czech conformity mark (3) must be marked before being placed on the market with a medical device which meets the essential requirements, taking into account the intended purpose of use, provided that the established conformity assessment procedure under paragraphs 8 (1) (b) (1), 8 (2) (a) and 8 (3) (b) (1) of Section 8 of this Directive consists in verifying the conformity of a medical device authorised by a person with its certified type on each medical device.
(2) Where medical devices which do not comply with the requirements of this Regulation are otherwise used for the purpose of demonstrating medical devices at exhibitions, fairs or fairs, they shall be visibly marked in such a way as to show that they cannot be placed on the market.
(3) The Czech mark of conformity shall be affixed 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 label shall be a Czech sign of conformity on the packaging of the medical device in which it is sold.
(4) The designation of the Czech conformity mark shall be accompanied, with the exception of Class I medical devices, by the identification number of the authorised person (5) which has carried out the assessment of the conformity (6) according to one of the procedures set out in Annexes II, IV, V and VI to this Regulation.
(5) Visibility and legibility of the marking by the Czech mark of conformity must not be reduced by other marks used; no marks and descriptions may be placed on the medical device, its packaging or in the instructions for its use, which may by mistake be regarded as a Czech mark of conformity.
Classification
Medical devices shall be classified according to the degree of risk posed by their use to users and, where appropriate, to other natural persons in Classes I, IIa, IIb and III; the inclusion of a medical device in one of those classes shall be carried out by the manufacturer or importer in accordance with the rules set out in Annex IX to this Regulation.
Conformity assessment procedures
The manufacturer or importer shall carry out or ensure, for a medical device, an assessment of the conformity (6) of its characteristics with the essential requirements, taking into account the intended purpose of use ("conformity assessment '), the procedures set out in Sections 8 to 10.
(1) For Class III medical devices which are neither custom nor intended for clinical trial, the manufacturer or importer shall proceed to:
(a) an assessment of the quality system by an authorised person in accordance with Annex II; or
(b) examination of the type of medical device authorised by the person referred to in Annex III with:
1. by verifying the conformity of a medical device with its certified type on each medical device or a statistically selected sample authorised by a person in accordance with Annex IV; or
2. an assessment of the production quality system as set out in Annex V.
(2) For Class IIa medical devices which are neither custom nor intended for clinical trial, the manufacturer or importer shall proceed with the conformity assessment referred to in Annex VII.
(a) by verifying the conformity of a Class IIa medical device with its certified type on each medical device or a statistically selected sample, by an authorized person in accordance with Annex IV; or
(b) an assessment of the production quality system as set out in Annex V; or
(c) an assessment of the quality system of medical devices as set out in Annex VI;
or in accordance with paragraph 3 (a).
(3) For Class IIb medical devices which are neither custom nor intended for clinical trial, the manufacturer or importer shall proceed to:
(a) an assessment of the quality system by an authorised person in accordance with Annex II with the exception of point 4 of this Annex; or
(b) examination of the type of medical device authorised by the person referred to in Annex III with:
1. by verifying the conformity of a medical device with its certified type on each medical device or a statistically selected sample authorised by a person in accordance with Annex IV; or
2. an assessment of the production quality system as set out in Annex V, or
3. an assessment of the quality system of medical devices as set out in Annex VI.
(4) For Class I medical devices with the exception of a custom medical device or a medical device intended for clinical trial, the manufacturer or importer shall, before placing it on the market, proceed with the conformity assessment procedure set out in Annex VII and Section 11 to this Regulation.
(5) The manufacturer or importer shall, before placing them on the market in accordance with Annex VIII, proceed with the processing of the declaration of conformity for a custom medical device.
(1) The certificate issued by an authorised person in accordance with Annex II or III is valid for a maximum period of 5 years and may be extended by an additional period of 5 years by the authorised person during its validity.
(2) Records, correspondence concerning the procedures referred to in Section 8, accompanying and manufacturing documentation of the medical device may be obtained in a language agreed between the authorised person and the manufacturer or importer.
Specific conformity assessment procedure for medical devices systems and kits and their sterilisation
(1) A natural or legal person who compiles medical devices marked with a Czech conformity mark within the meaning of the designated uses of the medical devices assembled to place them on the market for the first time as systems or kits shall draw up a declaration of conformity stating that:
(a) verify the compatibility of the medical devices assembled in accordance with the instructions of their manufacturers or importers, as appropriate, and ensure that they are put into service in accordance with those guidelines; and
(b) pack a complete system or kit and attach to it adequate information for users, including instructions from individual producers or importers, as appropriate; and
(c) its activities in compiling medical devices comply with the relevant internal control methods.
(2) Where the conditions referred to in paragraph 1 are not met, in particular where the system or the assembly of medical devices is not in accordance with their intended purpose of use, that system or assembly of medical devices shall be considered as a separate medical device subject to the procedure laid down in paragraphs 8 and 9.
(3) A natural or legal person who, for the purposes of placing on the market, sterilises the systems or sets of medical devices referred to in paragraph 1 or other medical devices marked with a Czech conformity mark intended for sterilisation by their manufacturers or importers before their use in the framework of the provision of medical care, shall choose one of the procedures set out in Annexes IV, V or VI; the application of these Annexes and the activity of the authorised person is limited to procedures to achieve sterility. The natural or legal person referred to in the previous sentence shall draw up a declaration of conformity in accordance with Article 11 and Annex VIII, with the sterilisation being carried out in accordance with the manufacturer's or importer's instructions.
(4) The individual products referred to in paragraphs 1 and 3 must not subsequently bear the Czech mark of conformity; However, the information referred to in point 11 of Annex I shall be provided, which shall contain the data of the manufacturers and, where appropriate, importers of medical devices which have been assembled. The declaration of conformity referred to in paragraphs 1 and 3 shall be kept on the market by the person referred to in those paragraphs for a period of 10 years after the last system or set of medical devices for which a certificate of conformity has been issued.
Declaration of conformity
(1) The declaration of conformity shall be drawn up in the Czech language and shall contain the following particulars:
(a) the identification details of the manufacturer or importer issuing the certificate of conformity (first name and last name, residence, place of business and the identification number of the natural person or name or, where applicable, trade name, registered office and identification number of the legal person);
(b) identification data on the medical device (e.g. name, type, mark, model), for imported medical devices also identification data on the manufacturer;
(c) a description of the medical device, its intended purpose of use, the class referred to in Article 6 and, where appropriate, other information on the medical device at the discretion of the manufacturer or importer;
(d) a list of technical regulations, harmonised Czech technical standards (hereinafter referred to as "standards"), 7) used in conformity assessment and a list of other specific regulations used, 8)
(e) the name (trade name), registered office and identification number of the authorised person, if that person was involved in the conformity assessment (including the certificate number and date of issue);
(f) the name and surname, residence, place of business and identification number of the natural person or the name (trade name), registered office and identification number of the accredited person, if that person was involved in the conformity assessment (including the certificate number and date of issue);
(g) the date and place of issue of the declaration of conformity, the names and functions of the responsible persons of the manufacturer or importer and their signatures;
(h) a declaration by the manufacturer or importer that:
1. the characteristics of the medical device satisfy the essential requirements and, where appropriate, the requirements of other technical regulations and procedures; and
2. the medical device is safe for the intended purpose of use under normal conditions; and
3. The medical device is intended for single or repeated use only under specified hygiene conditions,
4. take measures to ensure compliance of all medical devices placed on the market with their technical documentation and with essential requirements.
(2) Where there is a change in the facts on which the declaration of conformity for a medical device to be placed on the market and put into service has been issued, and where such changes may affect the characteristics of the medical device in terms of essential requirements, the manufacturer or importer shall issue a new declaration of conformity. Other amendments which do not change the intended purpose of use shall be indicated in the Appendix to the declaration of conformity.
Notification and recording of adverse events
(1) An adverse event is considered to be
(a) any failure, deterioration of the characteristics and, where appropriate, the effectiveness of the medical device, or inaccuracy in the indication of the medical device or, where appropriate, in the instructions for its use, which may or may have led to the death of the user or other natural person or to a serious deterioration of their health; or
(b) a technical or medical reason relating to the characteristics or effectiveness of a medical device and leading, for the reasons referred to in (a), to the systematic withdrawal of a medical device of the same type from the market.
(2) Notification and registration of adverse events is a specific technical procedure to address deficiencies in the medical devices put into service, in particular to prevent the risk or harm to the health of the population. Where the State Institute for Drug Control (hereinafter referred to as "the Institute ') finds or becomes aware of an accident or has been informed of it otherwise than in accordance with paragraph 3, it shall immediately inform the manufacturer or importer of the medical device concerned and shall take appropriate measures in cooperation with it.
(3) The manufacturer or importer shall immediately notify the Institute in writing of an adverse incident which he has identified or has been informed of if it has occurred in connection with a medical device of which he is a manufacturer or importer; the notification shall include:
(a) the name, surname, residence, place of production and identification number if the manufacturer or importer is a natural person, or the name (trade name), registered office and identification number if the manufacturer or importer is a legal person;
(b) the characteristics of the medical device specified in Annex I to this Regulation;
(c) the name (trade name), the registered office of the authorised person and his / her identification number if he / she has taken part in the conformity assessment of a medical device in the use of which an accident occurred;
(d) a description of the adverse event where and when it occurred, who identified it and, if known, the cause of its occurrence;
(e) the measures taken.
(4) The Institute publishes in the Bulletin of the State Institute for Drug Control an adverse event for which a causal link has been established between it and the use of a specific medical device in the provision of healthcare.
Common provision
This Regulation shall be without prejudice to the application of other specific provisions. 9)
Transitional provision
Medical devices which will be placed on the market after the entry into force of this Regulation but no later than 31 December 1999 may only comply with the requirements applicable under the legislation in force before the entry into force of the law.
Efficacy
This Regulation shall enter into force on 1 October 1998.
Prime Minister:
Ing. Tošovský v. r.
Minister for Health:
Dr. Roith, MBA v. r.
Příloha č. I
Annex I to Government Decree No. 180 / 1998 Coll.
ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
1. Medical devices shall be designed and manufactured in such a way that, for the intended purpose of use, they do not endanger the health and safety of users and other natural persons, provided that any risks which may be associated with the use of such medical devices are acceptable compared to their benefit to the patient.
2. The solutions chosen by the manufacturer in the design and construction of medical devices shall comply with the principles of safety, health and 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. Eliminate or minimise any risks (safe design and construction) of medical devices;
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 failure to achieve the full perfection of the safeguards implemented.
3. Medical devices shall be designed, manufactured and packaged in such a way as to be suitable for one or more of the functions referred to in Article 1 (1) of this Regulation in accordance with the manufacturer's specifications.
4. In the case of loads of medical devices which may occur under normal operating conditions, they shall not be adversely affected by their functional characteristics and efficacy within the meaning of points 1, 2 and 3 to such an extent as to avoid endangering the clinical conditions or safety of users or, where appropriate, other persons, during the life of the medical devices specified by the manufacturer.
5. Medical devices shall be designed, manufactured and packaged in such a way that:
5.1. Their characteristics and functional characteristics for the intended purpose of use are not adversely affected by the conditions of transport and storage, while maintaining the manufacturer's instructions and information,
5.2. It was easy to use.
6. Any adverse effects of medical devices must only constitute an acceptable risk compared to its anticipated effects in the areas referred to in § 1 (1) (a) to (d).
II. REQUIREMENTS FOR PROPOSAL, PRODUCTION AND PACK OF HEALTH EQUIPMENT
7. Chemical, physical and biological properties of the medical device.
7.1. Particular attention shall be paid to:
7.1.1. selection of materials intended for the manufacture and packaging of medical devices, in particular in terms of toxicity and, where appropriate, flammable substances;
7.1.2. mutual compatibility between the materials referred to in paragraph 7.1.1 and biological tissues, cells and body fluids, taking into account the intended purpose of use.
7.2. Medical devices 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 medical devices in accordance with the intended purpose of use. Particular attention must be paid to tissues exposed to these pollutants, the duration and frequency of such action.
7.3. Medical devices shall be designed, manufactured and packaged in such a way that they can be safely used together with substances and radiation which they come into contact with in normal use and usual procedures. If medical devices are intended for the administration of medicinal products, (1) they must be designed and manufactured in such a way that they are compatible with the medicinal products for the intended purpose and that their efficacy is maintained.
7.4. If a medical device contains as an integral part a substance which may be considered as a medicine1) and which acts on the body by an effect complementary to the effect of the medical device, the safety, quality and efficacy of that substance shall be verified for the intended purpose by the methods used for the testing of medicinal products. 10)
7.5. Medical devices shall be designed and manufactured in such a way that the risks caused by the substances or, where appropriate, the radiation from them are reduced to the minimum possible.
7.6. Medical devices shall be designed and manufactured in such a way that the risks of intrusion of undesirable substances into them, taking into account the nature of the medical device and the environment in which it is to be used, are reduced to the minimum possible.
8. Infections and microbial contamination.
8.1. Medical devices and manufacturing processes shall be designed in such a way as to eliminate or minimise the risk of infection with a medical device for users and other natural persons or vice versa as far as possible.
8.2. The tissues of animal origin used for the manufacture of medical devices shall come from animals under veterinary supervision to the extent appropriate to the use of such tissues.
8.2.1 Information on the geographical origin of these animals is kept by authorised persons.
8.2.2 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 optimum safety, in particular against viruses and their transmission in the manufacture of medical devices, by introducing validated methods designed to remove or deactivate viruses.
8.3. Medical devices made available on the market in sterile conditions shall be designed, manufactured and packaged in disposable packaging or, by appropriate procedures, ensure that they are sterile when placed on the market and remain sterile under specified storage and transport conditions until the protective packaging is opened or damaged.
8.4. Medical devices made available on the market in sterile condition shall be manufactured and sterilised in accordance with the appropriate approved procedure. 11)
8.5. Medical devices to be sterilised shall be manufactured in conditions with an adequate level of control of the production process. 11)
8.6. The packaging of non-sterile medical devices must ensure a specified level of purity of the medical device. If the medical device is to be sterilised before use, packaging must minimise the risk of microbiological contamination. The packaging shall be suitable for the application of the sterilisation method specified by the manufacturer.
8.7. Identical or similar medical devices placed on the market in both sterile and non-sterile conditions shall be mutually distinguished by packaging or labelling.
9. The design and characteristics of the medical device in relation to the environment.
9.1. If a medical device is intended for use in conjunction with another medical device or equipment, the whole assembly, including the interconnector system, shall be safe and shall not interfere with the effectiveness of individual medical devices. Any restriction on the applicability shall be indicated in the indication of the medical device or in the instructions for its use.
9.2. Medical devices must be designed and manufactured in such a way as to eliminate or minimise risks
9.2.1. injuries resulting from physical characteristics of medical devices, including the ratio of volume and pressure, dimensional or ergonomic characteristics,
9.2.2. Associated with reasonably foreseeable ambient conditions, in particular magnetic fields, external electrical influences, electrostatic discharges, pressure, temperature or changes in pressure and acceleration,
9.2.3. interaction with other medical devices used in diagnosis or therapy,
9.2.4. resulting from ageing of the materials used or loss of accuracy of the measuring or control mechanism and from the fact that medical devices cannot be maintained or calibrated (implants).
9.3. Medical devices shall be designed and manufactured in such a way as to eliminate or minimise the risks of fire or explosion. Particular attention should be paid to medical devices intended for use in the environment of flammable substances or substances which may cause combustion.
10. Medical devices with measuring function.
10.1. Medical devices with a measuring function shall be designed and manufactured in such a way as to provide sufficient accuracy and stability within the accuracy limits specified by the manufacturer with regard to the intended purpose of use.
10.2. The scale of gauges and displays shall be addressed in accordance with ergonomic principles taking into account the intended purpose of use.
10.3. The results of measurements carried out by medical devices with a measuring function shall be expressed in the units specified in the relevant standard.
11. Radiation protection.
11.1. General requirement.
11.1.1. Medical devices shall be designed and manufactured in such a way that exposure of users and other natural persons to the effects of radiation is reduced to the lowest possible extent, taking into account the intended purpose of use, without limiting the use of the necessary levels of radiation for diagnostic and therapeutic purposes.
11.2. Required radiation.
11.2.1. Where medical devices are intended to emit radiation at hazardous levels but necessary for a specific medical purpose, the benefit of which is considered appropriate to this risk, the user must be able to control the level of such emissions. Such medical devices shall be designed and manufactured in such a way as to guarantee the reproducibility of the relevant data variables within the limits of the tolerances for such reproducibility.
11.2.2. Where medical devices are intended to emit potentially hazardous visible or invisible radiation, medical devices shall, where possible, be equipped with visual displays or audible warnings to alert such emissions.
11.3. Undesired radiation.
11.3.1. Medical devices shall be designed and manufactured in such a way that the exposure of users and other natural persons to accidental or diffuse undesirable radiation is limited to the minimum possible.
11.4. Instructions for use.
11.4.1. The instructions for use of the radiation-emitting medical device shall include detailed information on the nature of the radiation emitted, the means to protect the user and the means to prevent the misuse of such radiation and the exclusion of risks arising from the installation of such a device.
11.5. Ionizing radiation. 12)
11.5.1. Medical devices intended to emit ionising radiation shall be designed and manufactured in such a way that, where the intended purpose of use so permits, the quantity, geometry and quality of the radiation emitted can be changed and controlled.
11.5.2. Medical devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way that the appropriate display or output quality for the intended diagnostic purpose is achieved at the lowest possible radiological load on the user of such devices.
11.5.3. Medical devices emitting ionising radiation intended for therapeutic radiology shall be designed and manufactured in such a way that reliable monitoring and management of the delivered dose, the type and energy of the beam of radiation can be achieved and, where necessary, the quality of the radiation.
12. Requirements for medical devices connected to or equipped with an energy source.
12.1. Medical devices containing electronic programmable systems shall be designed to ensure the functional stability, reliability and effectiveness of such systems in accordance with the intended purpose of use. If a defect occurs in this system, the resulting risks must be eliminated or reduced to the lowest possible level by an appropriate means.
12.2. Medical devices 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.
12.3. Medical devices for 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.
12.4. Medical devices intended to monitor one or more patient's clinical data shall be equipped with appropriate warning systems to report to the user a situation which could lead to the death of the patient or a serious deterioration of the patient's health.
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Regulation Information
| Citation | Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.07.1998 |
|---|---|
| Effective from | 01.10.1998 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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