How to get EUDAMED Single Registration Number (SRN)

[duinyk]

How do we get a “Single Registration Number”? I understand this number is provided by an electronic system that should be set up by the European Commission, as per Article 30. So, is this electronic system EUDAMED? However, I just tried to play around MDR-EUDAMED I do not have an SRN yet. I also couldn't find my AR in the system.

My question is how is this SRN to be gotten?

https://webgate.acceptance.ec.europ...registrations/edit/01DQZN1SD7ZJSFG40ME4NJGPBA

 

[dgrainger]

It's not running yet. The commission will inform us by 25th March 2020: Article 34.1....

1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The​

Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek​

to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in​

paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this​

Regulation and in Article 113 of Regulation (EU) 2017/746 are met.​

Updates here:
European database on medical devices (EUDAMED) - Internal Market, Industry, Entrepreneurship and SMEs - European Commission

 

[kreid]

You get the SRN from your Competent Authority. I have approached one CA recently and they responded that they are not ready to issue them yet.

 

[Marcelo]

And now that it seems that Eudamed will be officially delayed by 2 years, it will still take some time...

 

[duinyk]

It's not running yet. The commission will inform us by 25th March 2020: Article 34.1....

1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The​

Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek​

to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in​

paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this​

Regulation and in Article 113 of Regulation (EU) 2017/746 are met.​

Updates here:
European database on medical devices (EUDAMED) - Internal Market, Industry, Entrepreneurship and SMEs - European Commission

Thanks for these updates. Yes, I do understand its not running yet, but they had mentioned they were going to roll out a Test environment by the last quarter of 2019 for us to have a feel of it. Is that not available already? As I found this EU Login on the EC site.

 

[kreid]

Thanks for these updates. Yes, I do understand its not running yet, but they had mentioned they were going to roll out a Test environment by the last quarter of 2019 for us to have a feel of it. Is that not available already? As I found this EU Login on the EC site.

There is a test platform available now.

 

[duinyk]

There is a test platform available now.

Could you please help provide a direct URL to that? Thanks

 

[kreid]

Could you please help provide a direct URL to that? Thanks

Unfortunately, I cannot, I have seen a demonstration of the Eudamed Playground (as they call it) via COCIR. I think that maybe there was a registration process to get access.
Maybe try googling it?

 

[duinyk]

Unfortunately, I cannot, I have seen a demonstration of the Eudamed Playground (as they call it) via COCIR. I think that maybe there was a registration process to get access.
Maybe try googling it?

Thanks. Yes I have googled it and got this login page

EU Login

EU Login

On the EC commission site. But, I don't know if this was legit and had previously asked above on this thread.

Thanks

 

[Richard Houlihan]

Registrations for your SRN will start on December 1st 2020. The SRN is an automatically generated string that EUDAMED creates once your CA validates your registration.