Decree No 187 / 2021 Coll.
Decree amending Decree No. 62 / 2015 Coll., on the implementation of certain provisions of the Law on Medical Devices
Valid
Order
Effective from 26.05.2021
Text versions:
26.05.2021
07.05.2021
187
DECLARATION
of 28 April 2021
amending Decree No. 62 / 2015 Coll., implementing certain provisions of the Law on Medical Devices
According to Article 96 (2) of Act No. 268 / 2014 Coll., on in vitro diagnostic medical devices (hereinafter referred to as "the Act '), as amended by Act No. 90 / 2021 Coll., for the implementation of § 6 (2), § 45 (2), § 46 (5), § 59 (4), § 71 (6) and § 74 (5) of the Act:
Decree No. 62 / 2015 Coll., on the implementation of certain provisions of the Law on Medical Devices, is amended as follows:
1. In the title of the decree, the words "medical devices' are replaced by the words" in vitro diagnostic medical devices'.
2.
Subject matter
This decree regulates
(a) the rules of good storage and distribution practice;
(b) the extent of the information given in the prescription;
(c) details of documentation of in vitro diagnostic devices used;
(d) procedures for reporting suspected adverse events, adverse events, safety corrective actions and safety warnings; and
(e) generic groups of in vitro diagnostic devices. "
3. Article 2 is deleted.
4. The heading of Section 3 reads: "Rules of good storage and distribution practice."
5. Paragraph 3 (1) reads as follows:
"(1) The in vitro diagnostic device shall be handled in such a way that it is not exposed to adverse effects, it shall not be contaminated, damaged, stolen, degraded or confused, in particular the in vitro diagnostic device during storage and transport shall not be exposed to temperatures outside the temperature range specified by the manufacturer for the in vitro diagnostic device. ';
6. Paragraph 3 (2) is deleted.
Paragraphs 3 to 6 shall become paragraphs 2 to 5.
7. The introductory part of Paragraph 3 (2) reads: "The in vitro diagnostic device must be stored in such a way that '.
8. in Articles 3 (2) (b) to (d) and (f), 3 (3) (b), 7 (1) (e) and 7 (3), the words "medical devices" are replaced by "in vitro diagnostic devices."
9. in § 3 (2) (c), § 3 (3) (c), § 3 (4) of the introductory part of the provisions and points (b) and (c), § 5 (2), § 7 (1) (f) and § 12 (2), the words "medical devices" are replaced by the words "in vitro diagnostic devices."
10. in Article 3 (2), point (e) is deleted;
Point (f) shall be renumbered as point (e).
11. in Paragraph 3 (3) of the introductory part of the provision, the words "medical device" are replaced by the words "in vitro diagnostic device."
12. in Paragraph 3 (3), the word "a" shall be replaced by a comma at the end of (c).
13. In Article 3, at the end of paragraph 3, the dot is replaced by "a 'and the following point (e) is added:
"(e) identification of the manufacturer.";
14. in Article 3 (5), the words "shall be kept" shall be replaced by "shall be kept."
15. in Article 4 (1) to (3):
"(1) In vitro diagnostic devices must be stored in dry and clean storage areas for medical devices which must:
(a) comply with the temperature requirements provided that the manufacturer has established a specific temperature range for the storage of in vitro diagnostic devices, including their control of temperature measurements and records of at least daily maxima and minima; records of these measurements shall be kept for 3 years;
(b) be provided with effective measures against the intrusion of insects or other animals, dust, mold and other in vitro contamination of the diagnostic device;
(c) fulfil the condition that the floors and surfaces of storage areas are resistant to the cleaning and disinfection agents used; and
(d) comply with other specific storage conditions with regard to classification, if any, by the manufacturer.
(2) The areas for the hygiene needs of workers, cleaning facilities, rooms for the daily room and the place for the preparation and consumption of food must be separated from the areas for storage and distribution of in vitro diagnostic devices.
(3) A procedure shall be established for the storage and distribution of in vitro diagnostic devices to ensure the cleanliness and disinfection of premises and compliance with hygiene requirements. Compliance with these procedures shall be regularly checked and recorded. These records shall be kept for 1 year and be in place for inspection. ';
16. in Article 5 (1), "distribution and import activities" is replaced by "good storage and distribution practices."
17. in Article 5 (3), the words "shall be kept for 5" shall be replaced by "shall be kept for 3."
Article 18 (6), including the title, shall be deleted.
19. The heading of Section 7 reads:
"Scope of the data on the voucher
(Article 46 (5) of the Law) '.
20. in § 7 (1) (a) to (c):
"(a) the health insurance code if the in vitro diagnostic device is to be covered by the public health insurance system,
(b) identification of the patient containing:
1. name and / or name of patient,
2. patient contact address,
3. patient telephone number, if the patient agrees,
4. the number of the insured person, if assigned; if the insured person's number has not been allocated, the date of birth;
5. in the case of a patient who is located in the institution of the Prison Service of the Czech Republic, accused of a criminal offence, the address of the detention prison to which the patient has been taken, if any, in the case of a patient convicted of a criminal offence, the address of the prison to which he was placed for the execution of the prison sentence, and the address of the institution to which the patient was placed for the execution of the security detention; or
6. in the case of a voucher issued at the request of a patient who intends to use it in another Member State, the date of birth (1),
(c) the prescribed in vitro diagnostic device, the trade name under which the in vitro diagnostic device is placed on the market, the supplement to the name identifying the variant of the in vitro diagnostic device, if any, the assigned code under which the in vitro diagnostic device is registered by the Public Health Insurance Compensation Institute, or additional specifications and the number of packages in case it is a mass-produced diagnostic device in vitro; ';
21. in Article 7 (1), point (d) shall be deleted;
Points (e) to (j) shall be renumbered (d) to (i).
22. in Article 7 (1) (f) of the introductory part of the provision, the words "stamp imprint" are replaced by the words "identification" and the words "in paper form" are inserted after the words "services."
23. in Article 7 (1) (f) (1), the words "or names and surnames" shall be inserted after the word "name."
24. in Article 7 (1) (f) (2), the word "registered office" shall be replaced by "address of the registered office" and "assigned by the insurance undertaking," and "contact" shall be inserted.
25. In Article 7 (1) (g), the words "the name of the prescriber, written by a staff member or by a name," shall be replaced by the words "the name or, where appropriate, the name of the person authorised by an in vitro diagnostic device, and the words" the prescriber, namely an e-mail and a telephone or fax, "shall be replaced by the words" persons authorised by an in vitro diagnostic device, namely the address of the e-mail and telephone number. "
26. in Article 7 (1) (h), the words "prescriptive medication1)" shall be replaced by the words "persons authorised to prescribe an in vitro diagnostic device."
27. in Paragraph 7 (2):
"(2) If the payment of the in vitro diagnostic device is linked to the approval of the medical examiner of the relevant health insurance undertaking,
(a) the medical examiner on the front of the prescription shall give the endorsement "Approved by the medical examiner" or "Not approved by the medical examiner," the date of the decision, the registration number of the decision, the signature and the stamp of the competent medical examiner;
(b) the prescribing doctor on the front of the prescription shall indicate the endorsement "Approved by the medical examiner," the date of the decision of the medical examiner to approve the reimbursement, the registration number of the decision; or
(c) the prescribing physician shall, on the basis of the written consent of the revised medical practitioner with repeated prescription of the in vitro diagnostic device, state the endorsement "Approved by the revised medical practitioner," the date of the decision of the revised medical practitioner to approve the repeated remuneration and the registration number of the decision. "
28. In Article 7, the following paragraph 3 is inserted after paragraph 2:
"(3) The written consent document referred to in paragraph 2 shall be established by persons authorised to prescribe an in vitro diagnostic device no later than 5 working days from the date of its delivery to the patient's medical file. ';
Paragraphs 3 and 4 shall be renumbered paragraphs 4 and 5.
29. in the second sentence of Article 7 (4), "paragraph 2 (b)" is replaced by "paragraph 3."
30. in Article 7, paragraph 5 is deleted;
31. Sections 8 and 9 are deleted.
32.
Documentation requirements for in vitro diagnostic devices used
(To implement Article 59 (4) of the Act)
The documentation of in vitro diagnostic devices used for which instruction must be made, in vitro diagnostic devices for which, following the manufacturer's instructions, a safety technical inspection must be carried out and in vitro diagnostic devices designated by the law governing metrology as working meters shall include:
(a) the trade name of the in vitro diagnostic device;
(b) an addition to the name identifying the variant of the in vitro diagnostic device, if any;
(c) identification of the in vitro diagnostic device by the indication of the production batch number preceded by the symbol "LOT" or serial number, if any, by the manufacturer;
(d) the name or name of the manufacturer and distributor;
(e) the date of entry into service of the in vitro diagnostic device; and
(f) a record of the instructions, safety technical checks, repairs and revisions made for the in vitro diagnostic device. ';
footnote 2 is deleted.
33. In Articles 11 (2) and 11 (3), 12 (3) and 13 (1), the words "and the signed electronic signature guaranteed" shall be deleted.
34. In Article 11 (3), the words "medical device or type of device 'are replaced by the words" in vitro diagnostic device or generic in vitro diagnostic device group';
35. in Section 14 and Section 14 (1), the words "medical devices" are replaced by the words "in vitro diagnostic devices."
Efficacy
This Decision shall enter into force on 26 May 2021.
Minister for Health:
Prof. MUDr. Arenberger, DrSc., MBA, v. r.
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Regulation Information
| Citation | Decree No. 187 / 2021 Coll., amending Decree No. 62 / 2015 Coll., implementing certain provisions of the Law on Medical Devices |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.05.2021 |
|---|---|
| Effective from | 26.05.2021 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
Public Contracts 5
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