Regulatory Open Forum

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Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
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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
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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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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This is very helpful, deeply appreciate it, Kevin!

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Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
------------------------------

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.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

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

------------------------------
Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
------------------------------

Dear Jo,

just to be sure: Are you currently still in the review phase of your application and do not yet have an approved quality management system / design?

If this is the case it might make the discussion more complicated, because the provisions of the MDR for approval of changes mainly address changes made after the approval, not during the certification process (see e.g. MDR Annex VII 4.9 for the NB and Annex IX 2.4 and 4.10). Usually the contractual arrangements with the NB also focus on this case. However, because of the long review times it is more common now that some changes occur during the review process. In this case it might be possible to talk to the NB if there was a possibility to collect the changes and do one summary assessment after the review round. Alternatively you could formally suspend changes until after certification and then assess them as part of the "normal" MDR change procedures.

Best regards, Christoph

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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
------------------------------

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
------------------------------

Hi Christoph,

Thank you so much for your advice! We have obtained CE marking under MDD and our MDR "conversion" application has been under review for almost two years during which a lot of non-significant changes have been made mainly by our suppliers. While in the US, these are either 30-day notice or AR, it has become extremely challenging and time-consuming to submit all these changes to NB for approval. For example, for a like-to-like change on a coating material of a non-patient contact component (supplier changed their supplier, all specs/formulation remain the same), we would receive at least 2 rounds of technical questions if not 4. We are looking at 2 months at minimum for approval on changes of this sort and a significantly longer turnaround time for other changes that are not as straightforward. Besides potential supply interruption, we want our EU customers to be able to have the latest design and fresh batch right after MDR approval just as the US and ROW. That said, I doubt our NB would allow us to go with the "bundling" approach after the review round but let's see. Thanks again for your time and suggestions.

BR,

Jo

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Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
------------------------------

Original Message:
Sent: 25-Jan-2024 07:48
From: Christoph Kiesselbach
Subject: NB's Legit Reasons for Micro Review on Non-Significant Changes

Dear Jo,

just to be sure: Are you currently still in the review phase of your application and do not yet have an approved quality management system / design?

If this is the case it might make the discussion more complicated, because the provisions of the MDR for approval of changes mainly address changes made after the approval, not during the certification process (see e.g. MDR Annex VII 4.9 for the NB and Annex IX 2.4 and 4.10). Usually the contractual arrangements with the NB also focus on this case. However, because of the long review times it is more common now that some changes occur during the review process. In this case it might be possible to talk to the NB if there was a possibility to collect the changes and do one summary assessment after the review round. Alternatively you could formally suspend changes until after certification and then assess them as part of the "normal" MDR change procedures.

Best regards, Christoph

------------------------------
Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany

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

------------------------------
Jo Huang RAC
Dir, Regulatory Affairs
San Diego, CA
------------------------------