The below should be useful for any IVD or medical device manufacturer who seeks to, on a voluntary basis, register their ‘economic operators’ (i.e., their manufacturers, importers and authorized representatives) in the new European ‘EUDAMED’ database early.
The motivation for seeking this early/voluntary registration would be to receive, ahead of time, the coveted Single Registration Numbers (SRNs) that those economic operators will need for IVDR/MDR compliance.
The European Commission has made available the EUDAMED Actor registration module for voluntary use by its Member States and economic operators today.
The EUDAMED database is a key enabling feature (central database and collaboration tool) of the new Regulations, and its Actor registration module will need to be used to register economic operators such as manufacturers, authorised representatives, importers and system/procedure pack producers acting in the field of medical devices and in vitro diagnostic medical devices in Europe. Distributors remain to be managed by the National Competent Authority and if the local law requires, in the national database.
The advantage of getting a Single Registration Number (SRN) early is to include it in relevant regulatory documentation (Declaration of Conformity, Technical Documentation, Certificates issued by a Notified Body and Certificate of Free Sale) without the need of updating them at a later stage as the SRN will remain stable. SRN also enables the use of future EUDAMED modules to be released (e.g. for UDI/Device registration).