THE MEDICAL DEVICES VIGILANCE SYSTEM

The medical devices vigilance system is a system for reporting and evaluating incidents and field safety corrective actions (FSCA). This system is primarily aimed at the health and safety of patients, users and others by reducing the likelihood of an incident reoccurring at another location. This is done by evaluating reported incidents and, where appropriate, disseminating information which could be used in order to prevent the recurrence or mitigate the consequences of such incidents.

INCIDENTS

Manufacturers are obliged to report to the relevant Competent Authority, observing the deadlines provided in the legislation in force, serious incidents involving medical devices made available on the EU market. The NAMMDR is the Romanian Competent Authority in the field of medical devices.

Authorised representatives must immediately report serious incidents and suspected serious incidents involving the manufacturer’s medical devices to the manufacturer.

Importers must immediately report serious incidents and suspected serious incidents involving the manufacturer’s medical devices to the manufacturer and the manufacturer’s authorised representative (as applicable).

Distributors must immediately report serious incidents and suspected serious incidents involving the manufacturer’s medical devices to the manufacturer, the manufacturer’s authorised representative (if applicable) and the importer.

According to the requirements set out in Articles 13 and 14 of the MDR, if an importer or a distributor based in Romania considers or has reason to believe that a device is exposed to a serious risk or is a counterfeit device, they must inform the NAMMDR about it. If the device in question is also available in other EU member states, the distributor or importer must inform the competent authorities in the affected markets about the potentially serious risk or about the counterfeit device.

Healthcare professionals, patients and users must report any suspected serious incident related to the medical devices they handle to the NAMMDR within maximum 15 days from the date of the incident, depending on the consequences generated.

Patients or, as the case may be, relatives or legal representatives of patients may inform the attending physician, the economic operator from whom they purchased the medical device and the NAMMDR, when they suspect the occurrence of any serious incident, as a result of the use of the respective medical device.

CORRECTIVE ACTION REPORT ON FIELD SAFETY

A field safety corrective action is a corrective action taken by a manufacturer, for technical or medical reasons, in order to prevent or reduce the risk of an incident occurring in relation to a medical device made available on the market. Field Safety Corrective Actions are brought to the attention of Competent Authorities via the Field Safety Corrective Action (FSCA) form.

Field safety corrective actions may consist of: changes to the medical device, recommendations provided by the manufacturer regarding the use of the device and/or follow-up of patients, users, etc. or returning a medical device to suppliers.

Manufacturers bring field safety corrective actions to the attention of operators/users through Field Safety Notifications (FSN).

Applicable documents:

Regulation 2017/745 on medical devices (MDR) – Articles 87-92
Emergency ordinance no. 46 of 9 June 2021 – Article 9
Order of the Minister of Health no. 3876 of 16 November 2023 on amendment and supplementation of certain regulatory documents in the field of medical devices and in vitro diagnostic medical devices – Art. I
Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – Articles 82-87
Emergency Ordinance no. 137 of 12 October 2022 – Art. 7
MEDDEV 2.12-1 (https://ec.europa.eu/docsroom/documents/32305/attachments/1/translations)

Useful forms:

Manufacturer Incident Report (MIR) – version valid from 1 January 2020
https://ec.europa.eu/docsroom/documents/41681

Field Safety Corrective Action (FSCA)
https://ec.europa.eu/docsroom/documents/32305/attachments/4/translations

Field Safety Notice (FSN)
https://ec.europa.eu/docsroom/documents/32521

Form for reporting suspected serious incidents related to medical devices – for healthcare professionals, users and patients
descarca documentul …
descarca documentul …

NOTE

Manufacturers, healthcare professionals, patients and users can report vigilance issues as follows:

– in electronic format: mdevice@anm.ro

OR

– in written format at:
THE NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES OF ROMANIA
48 Aviator Maior Ștefan Sănătescu, 011478, sector 1, Bucharest