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  • 1.  MDR Significant Change & MDCG 2020-3

    This message was posted by a user wishing to remain anonymous
    Posted 17-Dec-2020 08:54
    This message was posted by a user wishing to remain anonymous

    Hello RAPS community,

    As we finalize our internal SOP for managing changes post-DoA (for MDD-certified devices), I'm having some trouble interpreting the MDCG 2020-3 guidance. 

    This guidance categorizes changes as "significant according to Article 120" or "non-significant according to Article 120". It obviously does not give details of how "non-significant changes" will be handled by notified bodies, but our current interpretation for our own NB is that such changes will likely need to be submitted and approved/agreed upon as non-significant, similar to what we would now classify as a significant change. (And of course changes classified as "significant" are just not possible until full transition to MDR.) 

    The guidance doesn't do a great job (IMO) of talking about what we would currently call non-significant changes – i.e., those that don't need any submission at all, and can be implemented within our quality system as an internal documentation change. The only information I see about this is in the first few paragraphs of Section 4 of the guidance, but I find it very difficult to interpret. 

    What I'm mainly trying to understand is this: if you only follow the flowcharts, everything will come out as either "significant" (i.e., not possible) or "non-significant" (which we interpret to require a submission). There are no paths that point to "internal documentation". I assume in the absence of any specific guidance from our NB, we will need to create another flowchart that details our internal assumptions about what would fall into this internal documentation category. Is anyone aware of any additional guidance to help here? Or am I missing something very obvious in this guidance?

    I'd be very grateful for any help from this community of experts!

  • 2.  RE: MDR Significant Change & MDCG 2020-3

    Posted 20-Dec-2020 18:10


    NB-MED/2.5.2/Rec2 is still useful in this context. It offers some guidance on developing the internal procedure for assessing the significance of changes.

    Anne LeBlanc
    Manager, Regulatory Affairs
    United States

  • 3.  RE: MDR Significant Change & MDCG 2020-3

    Posted 21-Dec-2020 04:33

    Hi anon,

    it's up to your current conformity assessment route and Notified Bodies process regarding 'changes' how to commence with this new demarcation of significant and non-significant changes. In line with agreed arrangements for notification of changes between your organization and your Notified Body according to the AIMDD/MDD (e.g. contractual relationships, approved procedures) changes and their implementation will be verified by the Notified Body as part of the surveillance activities, or following a manufacturer's submission for prior approval. This does not mean that all non-significant changes need submission to and approval from the Notified Body upfront.

    As I interpret this it means moving forward with the existing arrangements regarding significant and non-significant changes, using the 'new' definition of significant and non-significant changes.

    But to make things sure, I suggest to contact your Notified Body and ask for their arrangements for handling non-significant changes during the transitional provisions.

    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training

  • 4.  RE: MDR Significant Change & MDCG 2020-3

    Posted 22-Dec-2020 01:12
      |   view attached


    please check this document  issued by NB Team.

    Evangelos Tavandzis
    Lead Auditor, Consultant
    Czech Republic

  • 5.  RE: MDR Significant Change & MDCG 2020-3

    Posted 22-Dec-2020 03:54

    Hi Anon,

    I agree with the previous on that. You should read the current position paper from Team NB.

    Furthermore, it is not clear whether you have to report all the non-significance changes to your NB. And I am pretty sure that they do not want that either, because it is a huge bureaucratic burden on their system to have notes for non-significant changes all the time from their customers. They prefer to assess most of the non-significant changes during a surveillance audit.

    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens

  • 6.  RE: MDR Significant Change & MDCG 2020-3

    Posted 22-Dec-2020 09:36

    A device can be in one of three states:

    Full MDD

    MDD as modified by MDR Article 120

    Full MDR


    In the first two cases, the MDD applies to the device. This includes the conformity assessment path, Annex I, etc.


    Under MDR Article 120, the manufacturer cannot make any significant change in design or intended use. The guidance document provides the scope of significant change.


    If the change is significant, then the MDR applies. If the change is not significant then MDD continues to apply. In the MDD case, revert to the NB's requirement for change notification. Generally, there are two in your contract - one for the device and one for the QMS.


    In particular be cautious of MDD Annex II(4.4) which requires, "Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product".


    Dan O'Leary CQA, CQE
    Swanzey NH
    United States