Step 7: Register the device and the manufacturer

Registration has two parts and both involve uploading information to modules of the EUDAMED database. The obligations to register can be found in Articles 26 and Article 28. Article 28 requires economic operators (Manufacturers, Authorised Representatives and Importers) to register to obtain a Single Registration Number or “SRN”. Article 26 requires manufacturers to upload information about each device, including its UDI information.

In the first step of the registration process, the Manufacturer, Authorised Representative or Importer submits the so called economic operator information (US: establishment registration) as defined in Annex VI Part A Section 1. Once this information has been validated by the corresponding national competent authority, the Manufacturer, Authorised Representative or Importer is issued with a SRN.

Having received the SRN, the Manufacturer, Authorised Representative, or Importer is able to proceed with the second step and submit the information related to the device (US: device listing) as defined in Annex VI Part A Section 2, as well as the UDI data defined in Annex VI Part B.

The SRN is also necessary for other purposes, not only for registration of the device: With the SRN, the Manufacturer is able to prepare the EU Declaration of Conformity for the device as described in Annex IV.  If the device classification requires a Notified Body to be involved in the conformity assessment (see step 8), the SRN also enables the Manufacturer to submit the application to the Notified Body.

If the device doesn’t require the involvement of a Notified Body in the conformity assessment, all the steps necessary to begin marketing the device have now been completed. Manufacturers of certain class A 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 A IVD is not sterile (See Article 48, 10.).