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  • 1.  Notify Body audit for MDR transition

    Posted 19-Oct-2020 09:51
    Dear all,

    I'm preparing for a notify Body audit but I am confused with some questions asked, could you help me understand better please.
     -  Are there any procedure packs/ Article 22 activities? 
    what does it means ?
    -  Is there a strategy for regulatory compliance?
    I don't understand that question, do we need to have a procedure and write down a strategy for regulatory compliance. if yes can get an example please.
    -  Is there an SPR checklist and supporting procedure?
    is it the same as GSPR check list?
    - Are there any outsourced processes?
    what is it?

    Please could you advise.

    Thank you in advance for your help.

    Nadine Adia
    Quebec QC

  • 2.  RE: Notify Body audit for MDR transition

    Posted 20-Oct-2020 03:32
    Hi Nadine,

    • Article 22 describes the systems and procedure packs. You have to specify if you combine any other product with your device, such as other CE devices, ivd etc.
    • You need to have a specific procedure on how you plan to achieve regulatory compliance. You can describe the person responsible for regulatory compliance, the resources provided, trainings etc.
    • Yes it is the same. You have to build a table where you show which GSPR are applicable to your device and how you conform with these GSPRs. Be specific and reference the exact documents and applied standards. Also, provide a rationale on why some GSPR are not applicable to your products and not just write N/A.
    • You need to specify all the outsourced activities. There are numerous activities you can have outsources, such as a part or the whole production, sterilization, packaging, design, laboratory testing, biocompatibility studies, person responsible for regulatory compliance, vigilance and the list goes on and on.

    Hope that helps

    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens

  • 3.  RE: Notify Body audit for MDR transition

    Posted 20-Oct-2020 04:31
    Hello Nadine,

    In addition to what Spyros provided which is spot on ... make sure you understand expectations for the strategy for regulatory compliance.  In addition to having a procedure describing how this is done - and yes highly recommend having a procedure stated Strategy for Regulatory Compliance or similar - because the auditors will ask how this is done and looking for the wording.  In addition, there will also be inquiries about a Strategy for Regulatory Compliance for each product family - the procedure describes how this is done and the actual document contains the what for each product family.  I know this is still nebulous but until MDCG or EU Comission provides further guidance, still not clear how this is going to be completed.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Notify Body audit for MDR transition

    Posted 20-Oct-2020 06:38
    Hi Nadine.

    Regarding the strategy for regulatory compliance, BSI has published a brief guidance document on this subject in its 'Compliance Navigator' series, accessible from here:

    Best of luck!

    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665