Registration is required by Article 31 but the information to be submitted is listed in Annex VI Part A. Similar to the situation that currently exists with UDI (See Step 5), at the time of writing this article the EU Commission has still to make available the electronic registration system. Nevertheless, according to Article 31, Manufacturers, Authorised Representatives and Importers all have to register.
Registration commences with the Manufacturer, Authorised Representative or Importer submitting the information required by Annex VI Part A to their national competent authority. The national competent authority responds by issuing the Single Registration Number or “SRN”.
Once the Manufacturer, Authorised Representative, or Importer knows the SRN, they can continue with the registration process and upload the UDI data for the device to the UDI database. Again, at the time of writing this article this is still theoretical because the UDI database hasn’t yet been set up. However, having the SRN also enables the Manufacturer to prepare the EU Declaration of Conformity for the device as described in Annex IV.
If the device doesn’t require conformity assessment by a Notified Body, all the steps necessary to begin marketing the device have now been completed. Manufacturers of certain class I devices can bypass Step 8 and go directly to Step 9. On condition of course, they have complied with all the earlier steps and their Class I device is not sterile, not reusable and does not have a measuring function (See Article 52, 7.).
Deliverables for demonstrating compliance:
(1) The Single Registration Number,
(2) The UDI data uploaded to EUDAMED,
(3) The EU Declaration of Conformity.