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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.
    Rgds,

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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  • 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
    Greece
    ------------------------------

    Original Message


  • 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
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    Original Message


  • 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:
    https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/have-you-documented-your-strategy-for-regulatory-compliance/

    Best of luck!

    ------------------------------
    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
    www.donawa.com
    ------------------------------

    Original Message


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