Starting from May 2011, all states of the European Union will have to use Eudamed. The database shall be utilised to save data on medical devices sold on the European Single Market. Up till now, the data have only been saved on a national level. Here, the range of medical devices goes from life-supporting devices, like pacemakers, via hip replacements and X-ray machines to products of daily medicinal use. In this context, the database is intended to enable the supervisory authorities to access all relevant data quickly, states the Commission. The IT Tool is meant to facilitate quick access by the supervisory authorities to safety-relevant data in order to be able to initiate far-reaching measures (e. g. recalls) more quickly if they are deemed necessary. Besides, the database will facilitate the procedures for placing in-vitro diagnostics (IVDs) on the Market. Through Eudamed, the registration procedure will become simpler.
More information can be found here.
On behalf of the European Compliance Academy (ECA)