More details might be needed about the specific subject device and changes to be sure that we can definitively answer your question. But in general from purely a legislative EU MDR / MDD perspective, if an EU MDR Article 120(2/3) MDD-certified transitional device has, "...no significant changes in the design and intended purpose...", then it can be placed on the market or put into service under the MDD certificate until the EU MDR Article 120's corresponding sunset deadlines. This means that changes are in fact allowed to be made to the Article 120 transitional device, and the changed device can in fact be placed on the market, as long the change and the composite of multiple changes made since MDD certification, doesn't exceed the Article 120 limits.
However, sometimes your contract with the Notified Body might deviate with the pure legislative intentions of Article 120. So be sure to check your NB contract to see what obligations it demands. If that contract requires formal NB notification and/or approval of changes that don't align with the Article 120 provisions, then you would be legally bound by that contract and would thus need to lobby the NB for a contract revision or concession.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 23-Feb-2023 17:30
From: Anonymous Member
Subject: Next generation products while waiting for MDR...
This message was posted by a user wishing to remain anonymous
Million dollar question: does anybody have any suggestions as to how to get next generation versions of devices released while we wait 2 years for notified bodies to look at our files? Perhaps under some kind of humanitarian exemption? Anything? Our NBs said they will not even look at our files until 2024 after which they both expect an 18 month review. Original versions are certified under MDD that meet the existing MDR requirements. They are not high risk devices and the changes do not impact intended use or change any operating principles - we're talking additional sizes, varying thicknesses - none of which add or modify any additional risks.