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  • 1.  Remote MDR audits with Notified Bodies

    Posted 27-Jan-2021 12:56

    The allowance by the European Commission’s Medical Device Coordination Group (MDCG) for Notified Bodies to conduct remote MDR audits of medical device manufacturers during the COVID-19 pandemic has been unprecedented (and essential) move. As a member of the RAPS European Council (REC), I am interested in understanding if your organisation is prepared for a remote audit. Are you going to try and seek a remote audit with your Notified Body? How do you think this allowance will impact your ability to meet MDR/IVDR requirements?

     For more information about the REC and RAPS in Europe, please visit https://www.raps.org/who-we-are/raps-europe.



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    Gert Bos FRAPS, PhD
    CTO, Executive Director & Partner at Qserve Group
    Baarn
    Netherlands
    Gert.bos@qservegroup.com
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  • 2.  RE: Remote MDR audits with Notified Bodies

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jan-2021 09:33
    This message was posted by a user wishing to remain anonymous

    All our audits last year were remote. NB audit coming soon maybe remote too. We are accustomed now.
    Original Message


  • 3.  RE: Remote MDR audits with Notified Bodies

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jan-2021 16:56
    This message was posted by a user wishing to remain anonymous

    Our audit was mixed--part on-site/part virtual. Beside pandemic travel restrictions and hotel availability issues, the BLM riots threw in an additional logistical obstacle so the on-site visit was cut short and the audit finished as a virtual exercise.
    Original Message


  • 4.  RE: Remote MDR audits with Notified Bodies

    Posted 01-Feb-2021 07:31
    In our case, and being part of a standalone medical device software manufacturer, we are prepared for remote audits and this impact is positive in our ability to meet MDR requirements. 
    This could be even another discussion: would it make sense to allow remote audits after the COVID-19 pandemic, for specific cases where a physical audit is not crucial? 
    With the upclassification of most medical device software, many will now require Notified Body certification. Knowing that many of them come from small companies (and maybe in specific cases such as being based in countries with no NB), traveling costs for audits can be quite high and this possibility could reduce those costs significantly without affecting the audit requirements.


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    Celia Cruz
    Braga
    Portugal
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    Original Message


  • 5.  RE: Remote MDR audits with Notified Bodies

    This message was posted by a user wishing to remain anonymous
    Posted 01-Feb-2021 08:16
    This message was posted by a user wishing to remain anonymous

    Our last NB-audit was mixed on-site and remote. We did prior the audit some research until we found a file sharing system and a web meeting tool which comply to European/German data security regulations.
    And we trained both our people and the auditors with the software we used. Especially file sharing during a web meeting might need a bit to getting used to it (how do I make sure the auditor sees only what I want to show, which buttons do I have to click...). We also asigned some people for support of the remote audit (information of delays, file preparation, FAQ, help with the softeware, ect.)

    With these preparations the audit was smooth and we had other audits (with both suppliers and customers) fully remote. It was fine for us and we think, that it is a good addition to on-site-audits.
    Original Message


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