28/10/2010

Obelis O.E.A.R.C.

EUDAMED: The Medical Device databank in full use


What is Eudamed? – A secure web-based portal where EU competent authorities enter information received from manufacturers and notified bodies in order to exchange the information with the European Commission. Today the databank is used on a voluntary basis by national competent authorities.

The European Commission has adopted the decision (Commission Decision of 19 April 2010 on the European Databank on Medical Devices) to oblige EU Member states to use the Eudamed databank starting from 1st of May 2011. The European Medical Technology Industry association (Eucomed) sees the decision as a first step towards a less fragmented and more efficient EU medical device system. With the mandatory use of the databank, authorities will gain rapid access to information on manufacturers, authorized representatives, devices, certificates and vigilance and clinical investigation data. The databank will also streamline the registration rules when placing in-vitro diagnostic (IVD) devices on the market. Although, some areas would profit from being in a centralized system they are not yet covered by the decision, such as access to notified body reports and assessments by the competent authorities.

According to Eucomed, the use of ICT is a way to manage the regulatory system more efficiently and to improve patient safety in Europe. Eucomed will cooperate with DG SANCO and the member states to identify the most efficient ICT solutions to improve effectiveness and sustainability. If ICT is taken into consideration when the European Commission will revise the Medical Device Directives (MDD), it might result in expanding the Eudamed database or creating a new system.

According to Article 5 and Article 6 of the Decision, Member States will have to ensure that information regarding manufacturers, authorized representatives and devices for all medical devices currently on the market, and the devices going on the market until 1st of May 2011, are entered into the Eudamed by 30th of April 2012 at the latest. This is representing a lot of work to accomplish for the Member States in less than two years from now.

Obelis’ experts presume that the Competent Authorities most probably will collect the information from all device manufacturers and all EARs in their country. All information in the Annex will have to be collected, including certificates from Notified Bodies and clinical trials. The GMDN is not expected to be mandated for this task, as the Decision states that any “internationally recognized nomenclature” can be used. However this issue will be subject to each member state’s national laws. Obelis’ experts view this as a mammoth task requiring evaluation, preparation and careful planning by the European Authorities which will most probably result in different type of requests for information by the Competent Authorities.