MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances

[Watchcat]

Rumor has it that "they" are considering a Rev 5 of MEDDEV 2.7.1, to resolve inconsistencies with the MDR/IVDR. If possible, I'd like to participate in this somehow, but I've found it's a challenge to figure out who is doing what, how consultations work, and how groups are formed. Now I also understand that the MEDDEVs apply only to the MDD. Unless this changes, no point to a Rev 5. If it doesn't change, then it seems that some other group would have to take this up.

I can't serve on an expert panel, because I'm not a citizen of an EU Member State.

The EC website says that the MEDDEVs are developed in consultation with "interested parties," but I couldn't find a description of that process or who is an "interested parties." I also been told by someone with an NB that this statement is outdated and the EC is no longer following this process.

The website says the EC "supports" the efforts of a wide range of working groups, which would seem to imply that the working groups are not EC working groups, but instead external groups that it merely "supports." There is a list of working groups, including one on Clinical Investigation and Evaluation, but the link for the working group doesn't take you to any information on the working group itself, just information on clinical investigation and evaluation.

Can anyone here shed some light on any of the above?

 

[Ronen E]

I can't, but Erik Vollebregt is apparently very knowledgeable about the internal workings (including politics) of this intricate system.
Erik is very approachable, I recommend trying to contact him.

"Rev 5" is just a codename for a Rev 4 successor that will be aligned with the MDR. Of course it won't be Rev 5 per-se.

 

[Marcelo]

The roles of expert panels are described in the regulation (MDR).

It also details the MDCG responsibilities (MDR).

As I mentioned in another thread, the current MEDDEDVs are out of this new loop, because they all apply to the directives. However, the old structure is still being used in some specific cases.

The interested parties are usually the working groups linked in this link: Dialogue between interested parties - Internal Market, Industry, Entrepreneurship and SMEs - European Commission, so, as is common, regulatory documents are not discussed openly before a final draft or public consultation is created. As you noted, the link does not take to any more specific information, because this information is not, in principle, public.

 

[Marcelo]

I can't, but Erik Vollebregt is apparently very knowledgeable about the internal workings (including politics) of this intricate system.
Erik is very approachable, I recommend trying to contact him.

"Rev 5" is just a codename for a Rev 4 successor that will be aligned with the MDR. Of course it won't be Rev 5 per-se.

Erik (I don't know him personally) probably has a very good grasp, and as you mention, with added political understanding, but in fact most of the information the OP mentioned is online (albeit sometime difficult to find) and open. The think is that it may take a lot of reading a lot of different document (for example, you need to read documents about how the EC product regulations/directives in general work, as the medical device ones use them as a basis and only adds our changes things) and this is what I usually see: people reads the regulation text and want answers that exists, but is not on the regulation, it's in another set of documents that form the basis of the regulations.

 

[dgrainger]

There is a lot of work going on relating to clinical evaluation. The work groups usually comprised of representatives from the commission, competent authorities, notified bodies and industry bodies.

Dialogue with interested parties - Internal Market, Industry, Entrepreneurship and SMEs - European Commission

 

[Watchcat]

Erik Vollebregt is apparently very knowledgeable

Yes, Erik is very knowledgeable, approachable, and also very funny. He may have been too busy watching other aspects of the MDR transition to pay attention to this particular aspect of it, but this is a good suggestion, and I will ask him.

I think it could be Rev 5, if they decide to continue with MEDDEVs post-MDR/IVDR, but I'm guessing that they won't.

 

[Watchcat]

Thanks, everybody. All very helpful I have now found my way to this page on the EC website, which looks promising:

https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565

The TOR for the CIE Working Group says it's members will be appointed by "Member States and third countries participating in the MDCG." In EU speak, does anyone know if "third country" refers to one of the countries that isn't actually part of the EC, but has some sort of official relationship with it, or if that is just a way of saying "third party" when you know that the third party is a country, i.e., any other country that isn't part of the EC, official relationship or not?

 

[Marcelo]

Thanks, everybody. All very helpful I have now found my way to this page on the EC website, which looks promising:

https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565

The TOR for the CIE Working Group says it's members will be appointed by "Member States and third countries participating in the MDCG." In EU speak, does anyone know if "third country" refers to one of the countries that isn't actually part of the EC, but has some sort of official relationship with it, or if that is just a way of saying "third party" when you know that the third party is a country, i.e., any other country that isn't part of the EC, official relationship or not?

Switzerland, for example. This is generic text in all such regulations and related requirements.

 

[Watchcat]

But not the Ukraine or Tunisia or Peru, for examples?

 

[Marcelo]

But not the Ukraine or Tunisia or Peru, for examples?

I don't think these countries have participation in EU medical device regulations decisions.