Decree No. 11 / 2005 Coll.
Ordinance establishing the types of medical devices at increased risk for users or third parties and monitoring such devices for their placing on the market
Valid
Effective from 01.03.2005
11
DECLARATION
of 23 December 2004
laying down the types of medical devices at increased risk to users or third parties and on the monitoring of such devices after their placing on the market
According to Article 20 (3) (a) and (b) of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll., ("the Act '):
High-risk medical devices for users or third parties
Medical devices with increased risk to users (1) or third parties shall be considered as medical devices of classification classes IIb and III2) which are:
(a) non-invasive medical devices
1. intended to alter the biological or chemical composition of blood, other body fluids or other fluids intended for infusion into the body,
2. coming into contact with the injured skin, if they are intended to be used essentially in wounds where dermis (scale) has been broken and can only have secondary therapeutic effects,
(b) invasive medical devices related to body holes which are not surgically invasive medical devices and are not intended to be connected to an active medical device if they are intended for long-term use, except for use in the oral cavity to the pharynx, ear canal to the ear drum or nasal cavity and are unlikely to be absorbed by mucous membranes;
(c) surgically invasive medical devices for temporary use, if intended
1. specifically for the diagnosis, monitoring or correction of heart or central circulatory system defects by direct contact with these parts of the body;
2. to supply energy in the form of ionising radiation,
3. to induce a biological effect or to partially or fully absorb,
4. To be administered with medicinal products (3) using a dosing system in a potentially hazardous way,
(d) Surgically invasive medical devices for short-term use if intended
1. specifically for the diagnosis, monitoring or correction of heart or central circulatory system defects by direct contact with these parts of the body;
2. specifically for use in direct contact with the central nervous system,
3. to supply energy in the form of ionising radiation,
4. to induce biological effects or to partially or fully absorb them,
5. to perform chemical changes in the body (including medical devices placed in the teeth or to administer medicines),
(e) implantable and long-term surgical invasive medical devices, with the exception of those intended for tooth placement;
(f) active medical devices intended for
1. the supply or exchange of energy, if their characteristics are such that, taking into account the nature, density and place of application of energy, they can transmit or exchange energy into or out of the human body in a potentially dangerous way;
2. management or monitoring of the effectiveness of active Class IIb medical devices or intended directly to influence the effectiveness of such medical devices;
(g) active medical devices intended for direct diagnosis or monitoring of vital physiological processes, provided that they are specifically intended to monitor vital physiological parameters where the nature of the changes is such that there could be an immediate threat to the patient (such as changes in cardiac performance, breathing, central nervous system activity),
(h) active medical devices intended to emit ionising radiation as well as diagnostic and therapeutic interventional radiology, including medical devices which control or monitor such medical devices, or directly affect their effectiveness,
(i) active medical devices intended for the administration of medicinal products, body fluids or other substances into the body or for the disposal of medicinal products, body fluids or other substances from the body in a potentially hazardous way, taking into account the nature of the substances, parts of the body used and the method of application;
(j) medical devices
1. containing as an integral part a substance which, when used alone, can be considered as a medicinal product and which easily affects the human body with an effect complementary to the effect of the medical device;
2. used for contraception or to prevent the transmission of sexually transmitted diseases, including those which are implantable or long-term invasive;
3. specifically designed for use in disinfection, cleaning, rinsing or hydration of contact lenses; products intended for the physical cleaning of medical devices other than contact lenses are not covered by this provision,
4. manufactured using animal tissues or non-living derivatives thereof, except medical devices which are only intended to come into contact with intact skin;
(k) blood bags.
Monitoring of medical devices after their placing on the market
(1) The medical devices referred to in Article 1 are monitored 4) after their placing on the market. When monitoring medical devices, in particular in the context of their use in the provision of healthcare, particular vigilance (vigilance) shall be devoted to the possible occurrence of unforeseen situations or unusual conditions which cannot yet be considered an undesirable incident (5).
(2) The medical devices referred to in paragraph 1 used in the provision of healthcare for a particular patient shall be entered in his medical file. The person designated by the provider for the control of the medical devices used by him shall record the results of the check in the documentation kept pursuant to § 30 (1) and (2) of the Act.
Efficacy
This Decree shall take effect on 1 March 2005.
Minister:
Doc. MUDr. Emmer, CSc.
1) § 3 (e) of Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as amended by Act No. 130 / 2003 Coll.
2) Article 7 of Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended.
3) Article 2 (1) of Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts, as amended by Act No. 129 / 2003 Coll.
4) § 35 (a) and (e) § 2 of Act No. 123 / 2000 Coll. § 40 (2) (d) § 1 of Act No. 123 / 2000 Coll. Annex No 2, point 3.1.7, to Government Decree No 336 / 2004 Coll. Annex No. 4, point 3, to Government Decree No. 336 / 2004 Coll. Annex No. 2, paragraph 3.1.5, to Government Decree No. 154 / 2004 Coll., laying down technical requirements for active implantable medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain Government Regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain acts, as amended.
5) § 3 (g) of Act No. 123 / 2000 Coll.
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Regulation Information
| Citation | Decree No. 11 / 2005 Coll., establishing the types of medical devices at increased risk for users or third parties and monitoring them for their placing on the market |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.01.2005 |
|---|---|
| Effective from | 01.03.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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