EU MDR-Replacement Parts when not manufacture is not yet EU MDR compliant

S

SparksShallFly

Registered
#1
#1
Hi all,
We are diligently working on our EU MDR compliance (we are currently MDD compliant). We are concerned there may be a short period (1-2 months) of time where our MDD cert will expire and we have not received our EU MDR cert.
We already have product in the EU under MDD so we are concerned about replacement parts needed to maintain function of units already in the EU market.
Are we able to continue to sale replacement parts in the EU even though we do not have our EU MDR cert? Or are we at a complete stop for anything going into the EU without any cert?
Thanks in advance for your insight!
 
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Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
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#2
#2
There are a few options. Article 59 of MDR is a request for a derogation to a specific country to permit placement on market post-MDD expiration. Usually with an in-country partner making the request its likely to be approved. Alternately, Place parts in EU market prior to MDD expiration and ship as needed from within EU.

Per your direct question I am not sure though.
 
J

Junn1992

Quite Involved in Discussions
#3
#3
As per article 120 of the MDR:

"Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025"

There will definitely be issues with importing into the EU post 2024, so recommendation is to ship excess stock first.

Do note the following conundrum:

How can you make available on the market a MDD device with an expired certification after 2024?
Answer is: you cannot. You can't even sell a device which does not have a valid CE mark.

However, you can continue putting into service until 27 May 2025.
This refers to the stock already sitting in your customer inventory. So if you already sold to your customer before May 2024, they can continue to use the parts until May 2025.
 
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