Act No. 366 / 2017 Coll.
Act amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, as amended, Act No. 183 / 2017 Coll.
Valid
Law
Effective from 01.12.2017
Text versions:
01.12.2017
07.11.2017
366
THE LAW
of 11 October 2017
amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, as amended, Act No. 183 / 2017 Coll.
Parliament has decided on this law of the Czech Republic:
Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, as amended, as amended, Act No. 183 / 2017 Coll., is amended as follows:
1. in Paragraph 28 (2) (e):
"(e) for the service provider, a list of the manufacturers for whose medical devices the service is carried out, containing the business firm or the name of the person and the address of his registered office, a copy of the technical inspection training document referred to in Article 65 (4) (b) or a copy of the repair training document referred to in Article 66 (2) (b) from each manufacturer, or a copy of the authorised representative of the manufacturer or his authorised person, and a copy of the manufacturer's mandate of that person; and ';
2. In Article 59 (4) (b), the words "professional maintenance 'are replaced by the words" security technical inspection'.
3. In Article 59 (4) (c), at the end of the text, the word "established 'is added.
4. In Paragraph 61 (2), the word "instruction 'is replaced by" training', after the word "manufacturer ', the words" or authorised person or authorised representative of the manufacturer or authorised person' shall be inserted, and at the end, the phrase "Health Service Provider using these medical devices shall be added to ensure that the instructions of the personnel designated for their use or service are carried out. ';
5. In Paragraph 64 (1), the words "professional maintenance 'are replaced by the words" security technical control' and the words "professional maintenance 'are replaced by the words" security technical control'.
6. The heading of Section 65 reads: "Security Technical Control."
7. In Paragraph 65 (1), the words "professional maintenance 'are replaced by the words" security technical inspection' and the words "security technical controls and others' are deleted.
8. In Paragraph 65 (2), the words "professional maintenance 'are replaced by the words" security technical checks'.
9. in Paragraph 65 (3), the words "professional maintenance 'are replaced by the words" security technical control';
10. In Article 65 (4) of the Introductory Part of the provision, the words "which carry out a safety technical inspection 'shall be inserted after the word" service'.
11. in Article 65 (4) (a), the words "professional maintenance" shall be replaced by the words "security technical control," the words "biotech assistant," shall be deleted and the words "professional maintenance" shall be replaced by the words "security technical control."
12. in Article 65 (4) (b), the words "professional maintenance" shall be replaced by the words "security technical inspection," the words "and" this "shall be deleted, and the words" person authorised by the manufacturer "shall be replaced by the words" person authorised by him or his authorised representative, as the case may be, of the manufacturer. "
13. in Paragraph 65 (4) (c), the words "professional maintenance" are replaced by the words "security technical control."
14. in Paragraph 65 (4) (d), the words "professional maintenance" shall be replaced by the words "technical security controls."
15. In Paragraph 65, the sentence "After carrying out the security technical inspection, the person carrying out the service must ensure that the person carrying out the security technical inspection has obtained a written report on this inspection. 'is inserted at the beginning of paragraph 5, the words" lead and' shall be replaced by the words "record of professional maintenance carried out during the period 'shall be replaced by the words" throughout the period of use of the medical device, and thereafter for the period'.
16. in Paragraph 65 (6), "Requirements" is replaced by "Unless otherwise specified by the manufacturer," and "technical maintenance" is replaced by "security technical inspection."
17. in Paragraph 66 (2) of the introductory part of the provision, the words "which carry out the repair" shall be inserted after the word "service."
18. in Paragraph 66 (2) (b), the words "or authorised representative of the manufacturer or authorised person" shall be inserted after the words "manufacturer," and the words "manufacturer or person authorised by the manufacturer" shall be deleted;
19. in Paragraph 66 (3), the words "at least 1 year" shall be replaced by the words "throughout the period of use of the medical device, and thereafter for 1 year."
20. in Paragraph 66 (4), "Requirements" is replaced by "Unless otherwise stated by the manufacturer, requirements."
21. In Paragraph 67 (1), the word 'firm' shall be inserted after the words' which is'.
22. in Paragraph 90 (1), the words "professional maintenance" shall be replaced by the words "technical security controls."
23. in Article 90 (2), the word "service" shall be replaced by "security technical inspection" and the words "or 5" shall be added after the words "paragraph 4";
24. in Paragraph 90 (3), the words "register of service performed" shall be replaced by the words "protocol of safety technical inspection carried out."
25. in Paragraph 90 (4), "service" is replaced by "repair."
26. In Paragraph 90, the following paragraph 5 is inserted after paragraph 4:
"(5) A health service provider shall commit an offence by not maintaining a record of repair carried out for a legal period of time contrary to Paragraph 66 (3). ';
Paragraph 5 shall become paragraph 6.
27. in Article 90 (6) (a), "or 4" is replaced by "or 5."
28. in Paragraph 90 (6) (b), the words "or 4" shall be added after the words "paragraph 2."
Efficacy
That law shall take effect on the first day of the calendar month following its publication.
Hamlet v. r.
Zeman v. r.
Sobotka v. r.
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Regulation Information
| Citation | Act No. 366 / 2017 Coll., amending Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended, as amended, Act No. 183 / 2017 Coll. |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.11.2017 |
|---|---|
| Effective from | 01.12.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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