Eudamed enters into full force
The European Database on Medical Devices (Eudamed) is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of 1 May 2011. Eudamed becoming operational at last after having been a possibility referred to in the medical devices clearly marks the Commission’s and member states’ commitment to improve market surveillance for medical devices in the EU as a prelude to the impending Recast of the medical devices directives, by making sure that all authorities record and have access to certain market surveillance data. Whether, under what conditions and to what extent other parties, e.g. notified bodies, might have access to that database is still under debate as far as I can determine.
Vigilance and clinical investigation data
What will this entail? The decision obliges them to use the European Database on Medical Devices (Eudamed) to record vigilance and clinical investigation information and to make it accessible by all competent authorities in all EU countries. That means that all parties involved in market surveillance for medical devices in the EU must take int account that information obtained by one member states’ competent authority will immediately be available to all other competent authorities in the EU.
You can read up on the background in the Alert that I wrote for my clients last year. Basically only vigilance data and clinical investigation data is going to be recorded, under all three medical devices directives (and for IVDs, something more). See below for a more precise overview:
One IVD article 10 notification
Another novelty brought by Eudamed is that it will streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market by eliminating administrative hurdles for manufacturers of IVD devices. At present, they must notify every EU country concerned separately when placing certain IVD devices on the market, as required under article 10 of the IVD Directive. 1 May 2011 marks the end of the transitional period in article 10 (6) IVD Directive, as has been confirmed by the European Commission, so Eudamed allows streamlined registration by enabling entry of one notification in Eudamed.