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  • 1.  Article 120 - MDR transitional requirements

    Posted 01-Jan-2022 23:13
    Dear community,

    What are transitional requirements according to article 120 MDR? We are preparing for an upcoming audit. I want to ensure that we comply with those requirements. 

    Any feedback would be greatly appreciated.

    Thanks.


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    FATEME FARMAD
    Quality and Regulatory Affairs Associate
    Minnetonka MN
    United States
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  • 2.  RE: Article 120 - MDR transitional requirements

    Posted 03-Jan-2022 04:24
    Hello Fateme.

    There has been a few posts about this, recommend searching through the forum, such as: https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=d057749a-0296-4654-bc8c-d1f0c5161bce&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&ReturnUrl=%2fcommunities%2fcommunity-home%2fdigestviewer%3fcommunitykey%3d5af348a7-851e-4594-b467-d4d0983b6d89%26tab%3ddigestviewer.  The important thing to consider is there are many quality system aspects which need to be met.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Article 120 - MDR transitional requirements

    Posted 03-Jan-2022 11:20
    md_mdcg_2021_25_en.pdf (europa.eu)


    Regulation (EU) 2017/745 - application of
    MDR requirements to 'legacy devices' and
    to devices placed on the market prior to 26
    May 2021 in accordance with Directives
    90/385/EEC or 93/42/EEC

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    Michael Chellson
    MSc, RAC
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    Original Message


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