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.


Navigate through our knowledgebase

Related articles

Article

The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required

Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a…

Read more

Article

The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required

Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a very international business? Indeed – so the ability for companies working with the MDR and IVDR to transfer personal data internationally for all […]

Article

Impossible and Incredible And Yet Really Happened

What can we learn from the Impossible vs. Incredible case in the Netherlands? At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on […]