Economic operators in medical technology are subject to regulatory reporting and notification obligations, which must be fulfilled by institutional bodies at European and national level. This includes manufacturers, importers, and EU authorised representatives (also EC-REP / EAR).
Reportable includes:
In the event of a malfunction, deterioration of the characteristics or performance of a medical device already placed on the market, including ergonomic handling errors, undesirable side effects as well as inadequacies in the information provided by the manufacturer, the MDR refers to an "incident".
If such an incident leads to, has led to or could lead to (the suspicion or suspected causal link between the product and the incident is already sufficient here) that:
then the MDR speaks of a "serious incident". Article 87 of the MDR sets out corresponding notification deadlines to the relevant competent authorities, for example the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.
Type of incident | Reporting deadline | Comment |
Serious incident | Immediately, maximum after 15 days | The incident must be reported immediately after the (possible) causal link with the product has been established. In any case, however, the incident must be reported within the maximum period specified. |
Serious incident in the event of the death of a patient, user or third party, or of a serious temporary or permanent deterioration in their state of health. | Immediately, within a maximum of 10 days | |
Serious risk to public health | Immediately, maximum after two days |
It is essential to know the regulatory deadlines and to conduct and document the incidents and subsequent information processing in the organisation accordingly. This will ensure that the notification is made correctly and in a timely manner, considering the conclusions reached about the incident, in order to prevent further harm to the organisation.
If you have any queries about any of the following, please do not hesitate to contact us. NEMIUS offers comprehensive, short-term, and authoritative support in:
The European Database on Medical Devices (EUDAMED) is a central database for the management of medical devices in the European Union. It was developed to enable the uniform and transparent collection, storage, and provision of information on medical devices. The database serves the EU-wide management of medical devices and supports various aspects, such as the registration of manufacturers and authorised representatives, the surveillance of devices, the reporting of incidents and the provision of information to the public.
