Decree of the Ministry of Health No. 501 / 2000 Coll.
Decree of the Ministry of Health laying down the forms, ways of reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up to prevent and, in particular, repeat adverse events (Decree on adverse events of medical devices)
Valid
Order
Effective from 01.01.2001
501
DECLARATION
Ministry of Health
of 19 December 2000
laying down the forms, methods for reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up to prevent and, in particular, repeat adverse events (Ordinance on adverse events of medical devices)
The Ministry of Health provides, pursuant to Section 34 of Act No. 123 / 2000 Coll., on Medical Devices and on the amendment of certain related laws, hereinafter referred to as "the Act":
Notification of an adverse event
(1) The occurrence of an adverse event under § 3 (g) of the Act is reported to the State Institute for Drug Control (hereinafter referred to as the Institute)
(a) by telephone, fax, e-mail or mail; and
(b) the completed form for the first occurrence notification; the form of this form is set out in Annex 1 to this Order ("Form I ').
The scope and content of the report shall correspond to the availability of the necessary information for the subject reporting the adverse event.
(2) An adverse event shall be reported by telephone, fax or e-mail as soon as it is established or found. In the case of use of postal services, the date on which the completed form I has been certified to have been transmitted for transport shall be deemed to be the relevant date.
(3) Completed form I must be certified not later than
(a) 24 hours after the occurrence and, where appropriate, detection of an adverse event, if a natural person has died in connection with it;
(b) 3 days in other cases.
Reporting of adverse events
Evidence of adverse events within the scope of their mandate shall lead to:
(a) persons entitled to provide healthcare [§ 3 (d) of the Act];
(b) the Institute, and
c) Institute of Health Information and Statistics of the Czech Republic.
Investigation and evaluation of adverse events
(1) The investigation of adverse events is carried out by the Institute [Paragraph 40 (2) (c) of the Act]; This investigation shall be initiated at the point of origin or, where appropriate, at the point of detection of an adverse event.
(2) The information obtained in the course of the investigation is continuously evaluated and documented by the Institute in order to proceed as efficiently as possible in the investigation of an adverse event and to take appropriate measures, in particular to avoid recurrence of a similar adverse event.
(3) The documentation of the adverse event must be objective, concise and contain specific information on the data characterising the adverse event generally in a separate legal act [Paragraph 3 (g) of the Act]; This documentation shall be kept by the Institute after the investigation has been completed for the period specified in the specific legislation (Section 33 (2) of the Act).
Information on the outcome of the adverse event investigation
(1) The outcome of the adverse event investigation shall be reported in a completed form for the final adverse event reporting; the form of this form is set out in Annex 2 to this Order ("Form II '). Form II shall be completed by the Institute, in cooperation with the manufacturer of the medical device concerned by the adverse event, immediately after the completion of the investigation into the event.
(2) The completed form II will be sent immediately by the Institute to the Ministry of Health.
(3) If, for serious reasons, the investigation of an adverse event has not been completed within 30 days of the dispatch of the Form I form, the Institute shall inform the Ministry of Health of the adverse event during the investigation.
Follow-up of the medical device affected by the adverse event
(1) The persons referred to in Section 32 (1) of the Act, in the course of their activities, monitor the types of medical devices for which it has been established that one of them has been or may have been the cause of an adverse event, identify and maintain documentation of negative facts concerning the types of medical devices.
(2) Persons entitled to provide healthcare [Paragraph 3 (d) of the Act] and the Institute, in addition to the activity referred to in paragraph 1, shall also monitor the circumstances in which adverse events have occurred. the identified negative facts and, where appropriate, the negative effects shall be removed and documented.
This decree shall take effect on 1 January 2001.
Minister:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No 1 to Decree No 501 / 2000 Coll.
Form Even for the first reporting of adverse events of a medical device
Příloha č. 2
Annex No 2 to Decree No 501 / 2000 Coll.
Form II for the final reporting of an adverse medical device
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Regulation Information
| Citation | Decree of the Ministry of Health No. 501 / 2000 Coll., laying down the forms, ways of reporting adverse events of medical devices, their registration, investigation and evaluation, documentation and its retention and follow-up in order to prevent adverse events, in particular their repetition (Decree on adverse events of medical devices) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.12.2000 |
|---|---|
| Effective from | 01.01.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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