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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 to oblige EU Member states to use the Eudamed databank starting from 1 May 2011. The Official Journal of the European Union will publish the decision within the next coming days. 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 ITC is taken into consideration when the European Commission will revise the Medical Device Directives (MDD), it might result in expanding the udamed database or creating a new system.
Link to the European Commission’s press release: