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 occurring again 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.
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, it must inform the NAMMDR about this. 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 a maximum of 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 can 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 SAFETY IN OPERATION
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 the 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 tracking 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).
• Regulation 2017/745 on medical devices (MDR) – Article 87-92
• Emergency ordinance no. 46 of 9 June 2021 (OUG 46/2021) – Article 9
• Order of the Minister of Health no. 2882/2021 on how to report suspected serious incidents related to medical devices (OMS 2882/2021)
• Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – Articles 82-87
• Ordonanța de urgență nr. 137 din 12 octombrie 2022 (OUG 137/2022) – Article 7
• MEDDEV 2.12-1 (https://ec.europa.eu/docsroom/documents/32305/attachments/1/translations)
• Manufacturer Incident Report (MIR) – version valid from 1 January 2020
• Field Safety Corrective Action (FSCA)
• Field Safety Notice (FSN)
• Suspected serious medical device incident notification form – for healthcare professionals, users and patients
Manufacturers, healthcare professionals, patients and users can report vigilance as follows:
– in electronic format: firstname.lastname@example.org
– in written format at:
• THE NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES OF ROMANIA – THE GENERAL DIRECTORATE FOR MEDICAL DEVICES
58 Nicolae Titulescu, 011144, sector 1, Bucharest