European medical device database
The European database for medical devices (abbreviated Eudamed ) is a database operated by the European Commission and the EU member states for the central administration of medical devices .
According to a decision of the European Commission on April 19, 2010, all EU member states have had to use this database since May 2011. The data contained - such as certificates of conformity or data on clinical trials - are essential for the safety of medical devices. The former EU commissioner responsible for health and consumers said:
“The decision is good news for patients across the EU. It will increase patient safety because the national authorities will in future be able to access critical data quickly. "
The Eudamed database is intended to strengthen market surveillance because national authorities can quickly access critical safety data for medical devices that are on the EU market and thus react to risks, for example by ordering them to be withdrawn from the market.
Eudamed works with the secure hypertext transmission protocol HTTPS and the expandable markup language XML . When entering data in Eudamed, you can choose between entering data online or uploading XML files.
Individual evidence
- ↑ DECISION OF THE COMMISSION of April 19, 2010 on the European database for medical devices (Eudamed) (PDF)
- ↑ Press release of the European Commission: Patient safety: EU-wide database for medical devices to improve market surveillance from April 19, 2010.
Web links
- European Databank on Medical Devices - EUDAMED , European Commission - DG Health & Consumers - Public health
- Eudamed at DIMDI