Whatever happened to Eudamed 1.0?

[Watchcat]

If it is still accessible, I'd appreciate a link, but that's not really my question.

Everyone seems to agree that it wasn't exactly a glowing success. What I'd like to know is, why not?

Root cause, proximal cause, and/or symptoms would all be equally of interest to me.

 

[Ronen E]

Everyone seems to agree that it wasn't exactly a glowing success.

My general stance is that success can only be measured against defined goals.
What do "everyone" think Eudamed 1.0's goals were?

 

[Watchcat]

Mark me down as completely ignorant of the subject. I never had anything to do with it, never looked at it, not sure it was available to look at.

I have a general recollection of people saying years ago that the database itself was fine, but the problem was that there wasn't much in it. I don't know what was supposed to be in it, nor why. I realized recently that, when it comes to databases to search for CERs, it never seemed to be mentioned. More recently, once talk of a 2.0 began, there seemed to be a lot of references to hoping that it would work out better than 1.0. At what, I don't know either.

The other context in which I have heard it cited was in reply to someone searching vainly for a database of all CE Marked devices, and being told that there wasn't one, but that hopefully Eudamed 2.0 would provide one. Whether this means that 1.0 was supposed to provide one and failed, I don't know, either.

 

[Ronen E]

Let me fill you in quickly: Eudamed 1.0 was intended to serve mostly Competent Authorities, and (I think) to a somewhat lesser extent NBs. It was never really meant for the general public, definitely nothing like what Eudamed 2.0 is hoped to be one day. Probably what you "heard" came mostly not from CA or NB staff.
I think Eudamed 1.0 met its modest goals quite well (though like all SW systems it wasn't issue-free). That's the secret - if you don't aim too high and know your limitations, you are likely to succeed. I think that the main breakdown was with Member States / CA not uploading everything they were expected to, but that was more a regulatory/compliance breakdown (a lot of it was voluntary, I think).

 

[Watchcat]

Thanks. That fits with all the little pieces I have in hand. You are correct, not from CA or NB staff, but from people in industry. It also fit with the natural evolution of this sort of thing. First there is resistance, so you compromise by making it voluntary. Then time provides evidence to argue more strongly that voluntary doesn't cut it, and then you make at least some reporting mandatory. Sometimes with enforcement, sometimes not so much. Then time provides more evidence, and the bar gets raised again.

 

[Richard Houlihan]

Let me fill you in quickly: Eudamed 1.0 was intended to serve mostly Competent Authorities, and (I think) to a somewhat lesser extent NBs. It was never really meant for the general public, definitely nothing like what Eudamed 2.0 is hoped to be one day. Probably what you "heard" came mostly not from CA or NB staff.
I think Eudamed 1.0 met its modest goals quite well (though like all SW systems it wasn't issue-free). That's the secret - if you don't aim too high and know your limitations, you are likely to succeed. I think that the main breakdown was with Member States / CA not uploading everything they were expected to, but that was more a regulatory/compliance breakdown (a lot of it was voluntary, I think).

Ronen, You are correct Eudamed 1 was not mandatory. Eudamed 2 became mandatory for the reporting of NCARs in May 2011. And access was only to the EC and CA's, nobody else had direct access. NB's supplied their data to CA's who then uploaded to Eudamed 2. I managed Eudamed 2 from 2011 until 2019, and MDR Eudamed from 2017 to April 2020.