The Eudamed database, the first European database of medical devices, will be used by all health authorities in the EU from 1 May 2011.

The decision of the European Commission that use of the Eudamed database by EU member states will be obligatory from 1 May 2011 is a step towards the integration of medical device use across Europe's healthcare systems. Eudamed is already used on a voluntary basis by several EU countries.

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission. The authorities enter the required information into the database, based on data from manufacturers and notified bodies.

With this database, health authorities will have fast access to data on manufacturers and authorised representatives, on devices and certificates, and on vigilance and clinical investigation.

The decision has been welcomed by Eucomed, the European medical technology industry association.

"This is a significant first step in the right direction to make the EU medical devices system less fragmented and more efficient," said John Wilkinson, Eucomed's Chief Executive. "The next challenge is the multiplicity of different national registration systems. Together with the Member States and the European Commission, we must develop a single European registration system for medical devices.

"Until now, the ICT card has been underplayed in the regulations. Eucomed hopes that when the European Commission revises the Medical Devices Directive, we in Europe make full use of ICT to manage the regulatory system more effectively and ultimately improve patient safety in Europe. This may mean an expanded Eudamed or a new system, or even a network of interconnected EU databases."

 
John Wilkinson