Original Message:
Sent: 22-Jan-2024 16:13
From: Kevin Randall
Subject: NB's Legit Reasons for Micro Review on Non-Significant Changes
Europe's Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or claims, type, and chemical substances) without clear regard to significance so as to enable the NB to assess the impact. Because that includes a concomitant requirement for the NB to have in place corresponding documented procedures and contractual arrangements, you should start by reviewing your NB contract to see about the possibility for negotiation and to double check that the NB's requests are within the parameters of the contract. The best time to negotiate is before the contract is executed. Once executed, it is more difficult to realize deviations if either party doesn't like what's in the contract.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 22-Jan-2024 15:20
From: Jo Huang
Subject: NB's Legit Reasons for Micro Review on Non-Significant Changes
Dear Colleagues,
It has been very challenging to deal with our NB since we submitted our MDR for class 3, AIMD. While under MDR review, NB has been asking that we submit every and all changes, regardless of significance made to the product. We've been receiving micro review requests on non-significant changes that add unnecessary burdens to our R&D and production besides longer lead time and additional NB fees. Is this normal? Is there any room for negotiation? I'd love to hear your thoughts.
Many thanks,
Jo
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Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
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