Articles

The EU Commission has finally adopted a decision to make the use of Eudamed (the European databank for medical devices) mandatory as of May 2011. Eudamed was created in 1998 to allow Member States and the Commission to voluntarily exchange information on adverse events concerning the use of medical devices. However, its use until now has been rather infrequent.

Eudamed aims to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and devices across the EU, which is currently only available at national level. It is anticipated Eudamed will store data relating to certificates issued, renewed, modified, supplemented, suspended, withdrawn or refused; data on clinical investigations, and reports on malfunctioning of medical devices or incidents involving them.

Eudamed also aims to aid the uniform application of the medical device directives, in particular in relation to registration requirements. In this respect, it is worth mentioning that although the Commission's decision is addressed to Member States it will have direct advantages for manufacturers. For instance, it eliminates administrative hurdles for manufacturers of in vitro diagnostic (IVD) devices who will not have to notify the national authorities of each single Member State where they place their devices as from May 2011.

As far as manufacturers of devices other than IVDs are concerned, it is still unclear what positive effect Eudamed will have. Currently the relevant legislation require Class I and custom-made devices (as well as their manufacturers or authorised representatives) to be registered with the competent authority of the Member State where the manufacturer/authorised representative has its registered place of business. This registration requirement also applies to those involved in the placing onto the market (and/or sterilisation) of system and procedure packs. In relation to devices of Class IIa, IIb and III, Member States are allowed to request to be informed of all data allowing for their identification. In practice, this prerogative has resulted in a multiplicity of national registration systems which are hindering the single market for medical devices. In this respect, the European Medical Technology Industry association (Eucomed) has declared that, although the database will contribute to creating a less fragmented and more efficient system, a single European registration system for medical devices will need to be developed.

Another problem associated with Eudamed is the fact that it is not intended to be a publicly accessible database, which means that neither the industry nor doctors or the general public will have access to it. This is rather unhelpful for companies as they will not be able to verify whether or not a medical device is legally on the market in the EU or whether a competitor's device has been wrongly classified.

It seems that although overall Eudamed is good news for the industry, there is still room for improvement, in particular as regards the existing different national registration requirements.

The Commission decision can be accessed here.