An important aspect of the medical devices sector is to guarantee the safety of the products. To that end, the surveillance and vigilance of this sector are key.
The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries.
The Medical Devices Directives establish specific procedures that the national authorities must follow when considering whether or not:
- a medical device is unsafe and should be withdrawn from the market ('safeguard clause')
- a CE marking is unduly affixed to a device or missing ('wrongly affixed CE marking').
When justified, the European Commission ensures that such procedures are applied throughout the EU. In addition, EU countries are entitled to set requirements on health grounds regarding the withdrawal from the market or the placing on the market of a given product or group of products ('particular health monitoring measures'). Ideally, such measures should be adopted as EU measures.
The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
The Medical Devices Directives provide that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR).
This serves to prevent repetition of such incidents through the adoption of appropriate field safety corrective actions.
The provisions on vigilance of the Medical Devices Directives are complemented by general guidelines on vigilance intended for facilitating and harmonising the implementation of the EU Directives on Medical Devices by manufacturers and competent authorities.
Eudamed2 - European Databank on Medical Devices
Eudamed2 is the European Databank on Medical Devices. Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. It also contributes to a uniform application of the Directives.
Which information is stored in Eudamed2?
Depending on the applicable directive, Eudamed2 contains data
- on registration of manufacturers, authorised representatives and devices
- relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
- obtained in accordance with the Medical Device Vigilance System
- on clinical investigations
Who can access Eudamed2?
- Eudamed2 is a secure, web-based portal, which serves as a central repository for information exchanged between national competent authorities and the Commission and is not publicly accessible
- Eudamed2 use is obligatory since May 2011
- The operational functioning and the added value of the databank have been evaluated and the Eudamed2 Evaluation results are publicly available