Government Decree No. 130 / 1999 Coll.
Government Regulation amending Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices
Valid
Regulation
Effective from 30.06.1999
Text versions:
30.06.1999
130
GOVERNMENT REGULATION
of 2 May 1999
amending Government Decree No. 180 / 1998 Coll., 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 laws:
Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices, is amended as follows:
1. in Article 2 (a) and (b):
"(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 congenital anomaly 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 by specific legislation, '.
2. in Article 3 (b), (c), (d) and (e), including footnote 4, the following are added:
"(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 of use;
(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.
4) Decree No. 77 / 1981 Coll., on health professionals and other health professionals. '
3. Paragraph 5 (1), including footnote 3, reads:
"(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 referred to in Sections 8 (1) (b) (1), 8 (2) (a) and 8 (3) (b) (1) consists in verifying the conformity of a medical device authorised by a person with his certified type on each medical device.
3) Government Decree No. 179 / 1997 Coll., laying down the graphic form of the Czech conformity mark, its implementation and location on the product. '
4. In Paragraph 8 (2) at the end, the words "paragraph 3 'are replaced by the words" paragraph 3 (a)'.
5. In Paragraph 10 (1), the word "first time 'is inserted after the word" mentioned'.
6. In Paragraph 10 (4), the figure "5 'is replaced by" 10'.
7. In Article 11 (1) (b), the words "production number 'and" or importers' are deleted.
8. in Article 12 (3) (d):
"(d) a description of the adverse event where and when it occurred, who identified it and, if known, the cause of its occurrence."
9. In Annex II, point 3.2.3.5, the following point, also marked as point 3.2.3.5, is renumbered as point 3.2.3.6.
10. Point 6.1 of Annex II reads as follows:
"6.1. The manufacturer shall keep for at least 10 years after the production of the last type-approved medical device for the use of the competent authorities of the State. '
11. In Annex II, "3 and 4 'are replaced by" 3 and 4' in paragraph 6.1.3 and in paragraph 6.1.4 the word "4.2.2 'is replaced by" 4.2'.
12. In Annex II, point 6.1.5. after the designation of point "4.4. ', the comma is replaced by" and' and the words "and 5.4 'are deleted.
13. In Annex II, the following point 6.3 is added:
"6.3. The importer referred to in point 13.3 (a) of Annex I, or the person who places the medical device on the market in the Czech Republic, shall maintain access to the documentation relating to that device if the device is subject to the procedure laid down in point 4 for at least 10 years after the production of the last medical device of an approved type for the purpose of the competent authorities of the State in the event that the manufacturer or his authorised representative is not established for that purpose in the Czech Republic. ';
14. In Annex III, points 7.3. and 7.4. read:
"7.3. The manufacturer or his authorised representative shall keep at the disposal of the competent authorities of the State for at least 10 years after the last medical device of the approved type has been manufactured.
7.3.1. technical documentation of the type; and
7.3.2. type examination certificates and additions thereto.
7.4. An importer referred to in point 13.3 (a) of Annex I or a person who places a medical device on the market in the Czech Republic shall keep access to the technical documentation relating to that device for at least 10 years after the detection and certification that the sample of the medical devices being examined complies with the provisions of this Regulation which apply to it, where neither the manufacturer nor his authorised representative is established in the Czech Republic. "
15. In Annex IV, point 1, "§ 22 'is replaced by" § 12'.
16. Point 7 of Annex IV reads as follows:
'7. Administrative measures.
The manufacturer or his authorised representative shall keep and make available to the competent authorities of the State for at least 10 years after the manufacture of the last medical device of an approved type:
| 7.1. | prohlášení o shodě, |
| 7.2. | dokumentaci uvedenou v bodu 2. této přílohy, |
| 7.3. | certifikáty uvedené v bodech 5.2. a 6.4. této přílohy a |
| 7.4. | certifikát o přezkoušení typu podle přílohy č. III tohoto nařízení.". |
17. in Annex V, point 5.1, the words "the control authority" are replaced by the words "the competent authorities of the State" and the figure "5" is replaced by the words "10."
18. In Annex VI, point 5.1, the words "to the control authority 'are replaced by the words" for the purpose of the competent authorities of the State administration for at least 10 years after the production of the last medical device of the approved type'.
19. Point 1 of Annex VII shall read as follows:
"1. The conformity assessment by the manufacturer or importer [Paragraph 12 (4) (a) of the Act] is a procedure whereby a manufacturer fulfilling the requirements set out in paragraph 2 of this Annex finds, by itself or with the participation of an accredited person, the conformity of a medical device with the requirements of this Regulation; in the case of a medical device placed on the market in a sterile state and a medical device with a measuring function, in addition to the requirements set out in point 2, the requirements set out in point 5 of this Annex and, in itself or with the participation of an authorised person, establish compliance of the medical device with the requirements of this Regulation. The manufacturer shall then guarantee and declare that the medical device complies with the provisions applicable to it under this Regulation. ';
20. In Annex VII, the following point 7 is added:
'7. Administrative measures.
7.1. The manufacturer or his authorised representative shall keep and make available, for the purposes of the competent authorities of the State administration, the technical documentation referred to in point 3 of this Annex and the declaration of conformity for at least 10 years after the manufacture of the last medical device.
7.2. Where neither the manufacturer nor his authorised representative is established in the Czech Republic, the documents referred to in point 7.1 of this Annex shall be kept and made available by the person who places the relevant medical device on the market in the Czech Republic. ';
21. Point 4 of Annex VIII shall read as follows:
"4. The manufacturer shall keep and make available to the competent authorities of the State the documentation referred to in point 3 of this Annex and the declarations made under this Annex for at least 10 years after the production of the custom medical device. ';
22. In Annex IX, point 3.2.3., "terpautic 'is replaced by" therapeutic'.
This Regulation shall enter into force on the day of its publication.
Prime Minister:
Ing. Zeman v. r.
Minister for Health:
Dr. David, CSc.
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Regulation Information
| Citation | Government Decree No. 130 / 1999 Coll., amending Government Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.06.1999 |
|---|---|
| Effective from | 30.06.1999 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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