Actor Registration
The Actor Registration Module was the first module to be released (December 2020); the economic operators listed below are Actors and need be registered via EUDAMED:
- Authorised Representative.
- Importer.
- Manufacturer.
- System/Procedure Pack Producer.
All manufacturers must register with EUDAMED and acquire a Single Registration Number (SRN), non-EU manufacturer’s must indicate who their appointed EU Authorised Representative (EC REP) is when making their Actor application.
The EC REP verifies the application of the non-EU manufacture. Once confirmed, it is then validated by the EU competent authority in the member state where the EC REP is located.
Following a successful Actor Registration, a unique SRN will be issued to the Actor by the competent authority. This SRN may then show up on various documentation such as notified body assessment applications, CE Certificates, Declaration of Conformity, PMCF Plans etc.
And importantly once the manufacturer has an SRN it has additional access to EUDAMED modules.
For additional guidance on Actor Registration please click here [Additional Guidance]
UDI-DI Device Registration
This module allows manufacturers to register their devices which are placed on the EU market. The manufacturer will be required to register the Basic UDI-DI and subsequently the UDI-DI for all products which are intended to be placed on the EU market. This module is now live.
The intention of this module is to have a live picture of which devices are currently placed on the market and to have full traceability and visibility of UDI-DI. This registration process can be quite tedious, especially with uploading numerous UDI-DI.
When it comes to EUDAMED UDI-DI Device Registrations, as a manufacturer you do have some options.
- A manufacturer can carry out UDI-DI Device registrations in-house, this is the least costly option, however, there are hidden costs in reassigning an employee to carry out a task that is not part of their daily routine. It is time-consuming, burdensome and unfamiliarity can lead to errors. But the cost impact is minimised.
- In this scenario, should Advena also act as your EC REP Advena must still verify that the manufacturer has complied with its obligations under the MDR/IVDR.
- A manufacturer can outsource the UDI-DI Device registration activity to an organisation such as Advena. We have a team who are familiar with UDI-DI Device registrations. It is time-consuming, but crucially the manufacturer will not be burdened by having to find an employee who will take on this task while other tasks are delayed.
- In this scenario, should Advena also act as your EC REP Advena must still verify that the manufacturer has complied with its obligations under the MDR/IVDR. However, this verification will be considered complete as part of the registration process.
For additional guidance on UDI-DI Device Registration please click here [Additional Guidance]
When will this become mandatory?
EUDAMED is not yet fully functional and thus all obligations and requirements related to EUDAMED are currently voluntary; they will become mandatory 6 months after the date of publication of the notice that EUDAMED is fully functional within the Official Journal of the European Union (OJEU). However, we do recommend that actors at least register on the Actor Registrations module and begin to look into the workings of UDI/Device Registration.
How can we help?
If you need assistance in acquiring your Single Registration Number (SRN) we can take on the responsibility of submitting on behalf of the manufacturer their Actor Registration, once the process is complete the manufacturer is issued by the Competent Authority their SRN.
For more information and a quotation please contact us.
If you require help in adding all the necessary information to the EUDAMED UDI-DI Device Registration module we have a service that will help ease the burden, it is time-consuming so you may find this beneficial.
For more information and a quotation please contact us.
For further information regarding EUDAMED, click here.
