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.).
Deliverables for demonstrating compliance:
(1) The Single Registration Number,
(2) The UDI data uploaded to EUDAMED,
(3) The EU Declaration of Conformity.
Guidance
Guidance is also available from the Medical Device Coordination Group;
on the European Medical Device Nomenclature (EMDN)
- MDCG 2024-2 Procedures for the updates of the EMDN.
- MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN).
- EMDN The EMDN – The nomenclature of use in EUDAMED.
- CND The CND nomenclature – Background and general principles.
- MDCG 2018-2 Future EU medical device nomenclature - Description of requirements.
and on EUDAMED
- MDCG 2021-13 Rev. 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.
- MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices).
- MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
- MDCG 2019-5 Registration of legacy devices in EUDAMED
- MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
The European Commission has also established several web-pages dedicated to EMDN and EUDAMED, including a help desk.
Click this link to go to the EUDAMED database.
CLick this link to view and search the EMDN.
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