MDR - Legacy Device Review Timeframe and Requirements

#1
Something I still do not quite understand is the MDR legacy device review. I am based in Australia and we have a NB and EAR in the EU, with valid CE certificate (under MDD). We are not selling into Europe yet but we may do next year. Can someone help me with the following?
  • Are legacy devices are required to undergo a legacy device review even before they are sold into the EU market?
  • Can the legacy device review wait until we are ready to enter the EU market?
  • And what is the point of the review before EUDAMED is running?
For example, if I want to place my class IIa medical device (valid MDD) on the market, does this review need to be completed by the EAR first?
Also, if I do not wish to place on the market yet do I still need to have this review completed?
Is it a problem that the 26 May 2021 deadline has passed?

Thank you
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
We are a USA-based med dev company selling class IIa devices into the EU. Our MDD cert expires in 2023. For us, we comply with Article 120 of MDR. We are also working on Eudamed compliance by organizing our Economic Operator details with our Importer and distributor in the EU so we are ready for Eudamed in 2022
 
#3
We are a USA-based med dev company selling class IIa devices into the EU. Our MDD cert expires in 2023. For us, we comply with Article 120 of MDR. We are also working on Eudamed compliance by organizing our Economic Operator details with our Importer and distributor in the EU so we are ready for Eudamed in 2022
Thanks for your reply Ed, the information about organising Economic Operator details for Eudamed for 2022 is really useful as I am just looking into that at the moment.
Did you EU Authorised Rep perform a "legacy device review" to allow you to continue to place your device on the marker after 26 May 2021?
 

Billy Milly

Involved In Discussions
#4
Hi, I hope this helps - EU REP is acting on you behalf (as a manufacturer) on EU market. He should have the TF readily available on his site. Most of REPs (or at least serious ones) perform the TF revew before entering an agreement to avoid any potential future incompliance.
In my opinion, you will have to submit TF for review before the EU REP will agree to represent you.
In other words, review is not a regulatory requirement, but responsibility is.
Also, your scenario has no direct correlation with Eudamed requirements or timelines.
 
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