How to get EUDAMED Single Registration Number (SRN)

#11
The European commission has just published a detailed user guide that outlines the process to get your SRN for all economic actors (manufacturers, Authorised reps and importers. Go to the Europa site - search on Actor Registration module.
 
Elsmar Forum Sponsor
#12
Has anyone tried to apply for the SRN and the UDI?

I would like to incorporate a Class I medical device for a client and would appreciate your feedback.

Is this still a requisite, since this is a Class I medical device? Product is non-invasive, non-sterile accessory.
 

Steve M

Starting to get Involved
#13
Has there been any news on when the UK can register? I remember reading somewhere it could be by the end of the month.
 

Asia78

Involved In Discussions
#14
Has anyone tried to apply for the SRN and the UDI?

I would like to incorporate a Class I medical device for a client and would appreciate your feedback.

Is this still a requisite, since this is a Class I medical device? Product is non-invasive, non-sterile accessory.
Hi, yes, the eudamed is live and registration can start. However, when I did the registration for my company, i received an email which said there were issues to be fixed on the eudamed side and therefore we were not able to get any srs number. This was December 8th.
Regarding the registration: once the eudamed will be working, every device needs to be registered, also mdd devices
 

med_cert

Involved In Discussions
#16
Thanks for informing!

So both UDI and SRN are applied from the EUDAMED, correct?
No, UDI is not defined by the EUDAMED. The Commission has designated the following entities for UDI-DI numbers.

  1. GS1 AISBL
  2. Health Industry Business Communications Council (HIBCC)
  3. International Council for Commonality in Blood Banking Automation (ICCBBA)
  4. Informationsstelle für Arzneispezialitäten (IFA) Gmb
The SRN is defined by EUDAMED as soon as your competent authority confirms your data/application
 

Asia78

Involved In Discussions
#18
Thanks for informing!

So both UDI and SRN are applied from the EUDAMED, correct?
No, for UDI you need to have a contract in place with one of the issuing agency. There are many articles on this topic, if you are not familiar with the topic i suggest you to start reading as soon as possible. It takes time and many discussions...many. Good luck
 
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