When acting under the jurisdiction of the EU MDR, remember that the key onus of a Distributor is centered around the Distributor's obligations with respect to its making available of devices on the market. This "making available" is essentially a shipment/unit-based concept. So, in effect, the Distributor must merely assure EU MDR (or MDD as applicable) conformity of the subject devices before making the shipments/units available on the Union market.
Consequently, this certainly requires an appropriate level of correspondence with the manufacturer(s) in order for the Distributor to secure proper evidence of conformity. Yet it is also advisable to be sensitive to avoiding what may reasonably be considered by manufacturers as inappropriate or premature correspondence.
To figure out the proper level and type of correspondence, first remember that for MDD-certified (i.e., class I sterile or measuring, and class IIa, IIb, and III) devices whose legacy certificates are still currently valid, the manufacturers don't have to fully comply with the EU MDR until as late as 27 May 2024 [see EU MDR Articles 120(2) & (3)]. This transitional compliance date may also generally apply to class I reusable surgical instruments. And don't forget that class I devices that are nonsterile, non-measuring, and not reusable surgical instruments were generally required to be in full EU MDR conformity already earlier this year on 26 May. So be sure you are factoring these class-specific provisions into your Distributor compliance strategy.
Ultimately, Distributors should certainly query the manufacturers of the subject devices so as to determine if the subject devices are legacy devices aimed for Union marketing under the authority of an existing/valid legacy MDD certificate by way of Articles 120(2) & (3). If they are, then it could strain the business relationship between the parties if the Distributor demands EU MDR conformity evidence too far in advance of the applicable Article 120 transitional deadlines. But if the manufacturer is either currently obliged to EU MDR conformity or is voluntarily claiming EU MDR conformity in advance of the deadline, then the Distributor must by all means secure the Article 14 conformity evidence right away before making the subject devices available on the Union market.
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Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 24-Aug-2021 09:22
From: Anonymous Member
Subject: Obligations for distributors
This message was posted by a user wishing to remain anonymous
Hello, I'm a medical device distributor. In order to meet the MDR requirements, I started to contact manufacturers, but I have some doubts about the answers received. I asked if the declaration of conformity and the UDI of a medical device are compliant with the new MDR requirements, but I got many no as an answer and as motivation the fact that the device will switch to MDR once the MDD certification expired.
My question is: Am I allowed to request this information to manufacturers or do I have to wait for the renewal of certification under the MDR today?