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 European Union In Vitro Diagnostics Regulation (EU IVDR) for collecting data.
Compared to the current In Vitro Diagnostics Directive (IVDD), 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 EU IVDR. While this data collection is not totally new; EUDAMED was already established by the IVDD (Article 12), the amount of data currently available to the European Authorities is minimal compared to what is envisaged in the new EU IVDR.
According to the new EU IVDR Article 30, the databases established under the new EU IVDR 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 performance studies conducted in Europe, as well as vigilance and post-market surveillance data.
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 IVDR. Data uploading and maintenance is likely to characterise new era of the EU IVDR.
When will these new databases be available? For this information one has to look into the new European Union Medical Devices Regulation (EU MDR) Article 34. Article 34 of the EU MDR obliges the EU Commission to make EUDAMED available by 25th May 2020. However, Article 113 (f) of the IVDR makes clear the additional two years for EUDAMED for IVDs, although even the date of 26th May 2022 can be extended according to the new EU IVDR Article 113(f). From the go-live of EUDAMED; Manufacturers, Authorised Representatives and Importers will have six months to comply with the various obligations to upload data to EUDAMED.