The term Eudamed is used on this page to mean the whole collection of databases and electronic systems which will be established by the new EU MDR for collecting data.
Compared to the current Medical Device Directive (MDD), the amount of data which will be available to the European Authorities in the future is one of the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR). This data collection is not totally new. Eudamed was established by the MDD (Article 14a). But the amount of data currently available to the European Authorities is minimal compared to what is envisaged in the new EU MDR. According to the new EU MDR Article 33, the databases established under the new EU MDR will contain; comprehensive data on the devices themselves, including the Unique Device Identification (UDI) data, as well as data on all the economic operators associated with those devices. Data on the Notified Bodies and the certificates they issue. Data on clinical investigations conducted in Europe, as well as vigilance and post-market surveillance data.
Of course, all of this data has to be input to the database and maintained by someone. That will be the responsibility of the manufacturers, importers, distributors and authorised representatives, presumably via the European database “portal” mentioned in the preamble of the new EU MDR. Data uploading and maintenance is likely to characterise new era of the EU MDR.
When will these new databases be available? The new EU MDR Article 34 obliges the EU Commission to make Eudamed available by 25th May 2020, although this deadline can be extended according to the new Article 123(d). Article 123(d) also allows Manufacturers, Authorised Representatives and Importers six months from the going live of Eudamed to comply with the various obligations to upload data.