European Commission proposes mandatory use of medical devices database

Eudamed is a web-based portal for rapid information exchange between national authorities. It is already being used on a voluntary basis by a number of Member States. Despite the fact that medical devices are traded freely in the EU single market, data on their safety is currently only collected at the national level. Compulsory use of Eudamed will help streamline the rules for manufacturers and traders.

What are medical devices?

The term “medical device” covers a range of healthcare instruments – from simple bandages and dressings to complex life-support machines. Many definitions are currently in use, but it can be said that the intended primary mode of action of a medical device, in contrast with that of a medicinal product, is not metabolic, immunological, or pharmacological. A medical device is any instrument, apparatus, implement, machine, appliance, implant or software which is designed to diagnose, prevent, monitor, treat or alleviate disease. [1]

For further information

 The Eudamed Databank

 The Exploratory Process on Medical Devices

 The Commission Public Consultation 2008

Related EPHA articles
 Commission launches revision of the Medical Device Directives
 Seminar on re-processing medical devices safely, 28 January 2004
 Commission’s Statement on Regulatory Framework of Medical Devices
 Competent Authorities Meeting for Medical Devices