MDD legacy until 2024 - EUDAMED, role (and cost!) of the EC Rep

[marmotte]

Dear all.

Small Australian manufacturer here, Class IIa device (classification not impacted by the new rules).
Our "NB" has been historically (~13 years operation) the TGA under the MRA.
Our CA certificates (1 AU, 1CE) were reissued in 2019 (and updated 2020 with some changes that I could "slide in" just before the deadline ) with expiry April 2024. (Annex V, Production quality assurance).

I understand that I'll have to get a "proper" NB soon and get the ball rolling for a real MDR certification - nonetheless I'd like to get the MDD transition sorted out properly first. FYI we are not selling in Europe ATM but I am trying to secure a few distribution deals there.

Internally, we have:
Updated our QMS to comply with the MDR and the 13485:2015 (postmarket where the biggest changes).
Updated the tech files against the MDR (GPSR rather than essential principles was the biggest change) and issued new Decl of Compliance.

The 1 thing that is really puzzling me is the EUDAMED/UDI.
My understanding is that I do NOT HAVE TO implement new UDI labelling as per MDCG 2019-5 (legacy devices), but I have to register on the EUDAMED.
I tried doing it but because I am not a European Economic Operator, I need our EC REP to "approve" my registration.

To do it the EC REP is requesting me to pay them thousands of Euros to do a MDR Technical Documentation review (with months of delay unless I pay tens of thousands EUR for their "platinum fast service" and wait then only a few weeks) and issue a EAR MDR certificate.
TBH I find it dumb to have to spends thousands for them to do a "review" (they are not a NB, their review is purely bureaucratic) when I will have to have everything audited and really reviewed by a new NB.
We have a clean slate in 13 years operation, no recall, adverse event or anything like that, only a handful of products.

I read recently that the EUDAMED registration is a recommendation at this stage. Am I confused?
Could I get a distributor to "approve" our Eudamed registration if needs be rather than the EC REP?

Any advice welcome.
THX

 

[monoj mon]

I feel that in your case you don't have a way around by avoiding them. Your registration for SRN in EUDAMED needs to be approved by your 'Authorized Representative' since you will need to use their SRN as well as you will need to upload the EUDAMED Mandate summary (shown below) during registration. Once you upload all the necessary information in the system, your 'Authorized Rep' will verify the information and will pass it forward.

I am not sure if there is any other solution than this as this is a very new topic.

 

[mboynton]

Dear Marmotte,

As part of your transition preparation, have you already signed a new mandate with this EC Rep that covers their responsibilities under the EU MDR? If not, that could be an opportunity to negotiate and/or lessen the opportunity cost of switching to a new EC Rep, if there is still contractual work to be completed w/ the current one. Asking because the original post doesn't state either way.

You are correct that the EUDAMED registration is not yet a hard requirement, so you would have the option to move forward w/o Economic Operator registration during the period while EUDAMED is still being rolled out. See MDCG 2021-13, question #4 about when the registration obligation must be fulfilled for manufacturers of legacy devices - "manufacturers of only legacy devices will have to register as actors in EUDAMED. According to Article 123 (3) (d) MDR and Article 113 (3) (f) IVDR, the deadline for such registration is 6 months after the date of publication of the notice referred to in Article 34 (3) MDR (i.e., when EUDAMED is fully functional)".

This is an at-risk strategy, however, because should there be a serious incident that requires vigilance reporting, then that will require manufacturer & device registration in order to report the vigilance once the EUDAMED vigilance portal becomes active. This is also discussed in MDCG 2019-5.

 

[marmotte]

Many many thanks @mboynton and @monoj mon .

 

[somashekar]

To do it the EC REP is requesting me to pay them thousands of Euros to do a MDR Technical Documentation review (with months of delay unless I pay tens of thousands EUR for their "platinum fast service" and wait then only a few weeks) and issue a EAR MDR certificate.
TBH I find it dumb to have to spends thousands for them to do a "review" (they are not a NB, their review is purely bureaucratic) when I will have to have everything audited and really reviewed by a new NB.
We have a clean slate in 13 years operation, no recall, adverse event or anything like that, only a handful of products.

You could try negotiating with your EUREP the price only for the required task. If your rapport with them is good and you mean continuing business, there could be way around. They operate in the EU with first total immunity from any damages whatsoever and they are in the business to make euro too. But for sure, it could still cost you.

 

[malik_654]

Contact Maxcert EUREP, totally reasonable prices and fast working.... just sharing my own exp

 

[Junn1992]

Yea there's no way around the Rep because the guidelines state that for manufacturers not based in the EU, the rep has to verify the registration. Maybe set up EU office?