The new European Regulation 2017/745 on medical devices will introduce new activities and a new approach in the management of vigilance and post-market surveillance of medical devices.
A new definition of an “incident” will be introduced. In fact, according to the Regulation 2017/745, there will be a clear distinction between “incident” and “serious incident” based above all, on the gravity of the consequences.
In particular, it will be classified as “serious incident” any incident that, directly or indirectly, caused or could have caused the death or the serious temporary or permanent deterioration of the health condition of the patient, of a final user or of other person, or that represented or could have represented a serious threat for the public health.
It will be defined “incident” any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effects.
Another news is the introduction of an electronic system on vigilance and on post-market surveillance. As defined by the Article 92 the database will be created by the European Commission, with the collaboration of the Member States and it will serve to ensure a fast collection and management of the reports in a centralized process. Manufacturers will have to use this electronic system to report any “serious incident” to the relevant competent authority. Furthermore, manufacturers shall also report any field safety corrective action.
Other new activities on vigilance and post-market surveillance that manufactures should perform according to the European Regulation 2017/745 includes:
- Reporting trends on incident frequency
- The implementation of a Post-Marketing Surveillance Plan and of a Post-Marketing Clinical Follow Up Plan
- The PSURs preparation for class IIa, IIb and III Medical Devices
- The post market surveillance report preparation for class I Medical Devices
Don’t get caught unprepared!
Regulatory Pharma Net is available to provide support for all vigilance and post-marketing surveillance activities on Medical Devices and to provide additional information and advices on quality and regulatory aspects to be compliant to the new Regulation 2017/745.