Regulatory Open Forum

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  • 1.  Article 22 - MDR - Systems/Procedure Packs

    Posted 19-Jul-2021 01:39



    I am putting together an internal training/information sharing on Article 22.   I have the Medtech Q&As and guidances related.   Does anyone have any other material/slide decks that they could share with me?


    Many Thanks in advance,


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  • 2.  RE: Article 22 - MDR - Systems/Procedure Packs

    Posted 04-Aug-2021 13:43
    Dear Christina,

    You have also the podcast of Monir El Azzouzi, which is very interesting: .

    Kind regards


  • 3.  RE: Article 22 - MDR - Systems/Procedure Packs

    Posted 05-Aug-2021 02:27
    Monir and I made two podcasts: one with a general discussion of article 22 MDR and later a follow up one on specific questions.

    Erik Vollebregt

  • 4.  RE: Article 22 - MDR - Systems/Procedure Packs

    Posted 05-Aug-2021 05:48
    Thanks alot.

    Christina Donegan
    Snr Regulatory Affairs Specialist