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  • 1.  MDR extension proposal passed

    Posted 16-Feb-2023 08:19

    Dear RAPS'ers

    EU MDR extension proposal has been passed while we were having lunch (Central European Time). No changes were made to the initial proposal released Jan 6, 2023.

    Due to the urgency of the situation, >200 recommendations sent during the request for comment period could not be considered.

    The vote results: https://www.europarl.europa.eu/plenary/en/vod.html?mode=unit&vodLanguage=EN&internalEPId=1676545669560&providerMeetingId=b35b1f95-da68-4ade-b2ec-08db0827d6b6#

    https://www.europarl.europa.eu/plenary/en/vod.html?mode=unit&vodLanguage=EN&internalEPId=1676545626010&providerMeetingId=b35b1f95-da68-4ade-b2ec-08db0827d6b6#

    >200 feedback sent to the EC following their request for comment on the MDR extension proposal which were not considered are posted here. Possibly considered in the future...Let us wait and see.

    https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension/feedback_en?p_id=31767649

    Please read the MDR extension carefully.

    https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2023/0010/COM_COM(2023)0010_EN.pdf

    Some manufacturers will not be able to take advantage of the MDR extension due to the detailed conditions attached. 

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------


  • 2.  RE: MDR extension proposal passed

    Posted 17-Feb-2023 03:06
    Edited by Stephanie Grassmann 17-Feb-2023 09:47

    Original Message:
    Sent: 16-Feb-2023 08:18
    From: Stephanie Grassmann
    Subject: MDR extension proposal passed

    Dear RAPS'ers

    EU MDR extension proposal has been passed while we were having lunch (Central European Time). No changes were made to the initial proposal released Jan 6, 2023.

    Due to the urgency of the situation, >200 recommendations sent during the request for comment period could not be considered. 

    The vote results: https://www.europarl.europa.eu/plenary/en/vod.html?mode=unit&vodLanguage=EN&internalEPId=1676545669560&providerMeetingId=b35b1f95-da68-4ade-b2ec-08db0827d6b6#<o:p></o:p>

    Interestingly, one politician stood up and stated it was sad that there was no debate. 

    https://www.europarl.europa.eu/plenary/en/vod.html?mode=unit&vodLanguage=EN&internalEPId=1676545626010&providerMeetingId=b35b1f95-da68-4ade-b2ec-08db0827d6b6#

    >200 feedback sent to the EC following their request for comment on the MDR extension proposal which were not considered are posted here. Possibly considered in the future...Let us wait and see.<o:p></o:p>

    https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension/feedback_en?p_id=31767649

    Please read the MDR extension carefully.

    https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2023/0010/COM_COM(2023)0010_EN.pdf

    Some manufacturers will not be able to take advantage of the MDR extension due to the detailed conditions attached. 

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------



  • 3.  RE: MDR extension proposal passed

    Posted 17-Feb-2023 04:38

    Dear Stephanie, thanks for the update. 



    ------------------------------
    May Meng, PhD, RAC
    Senior Consultant
    Oxford
    United Kingdom
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  • 4.  RE: MDR extension proposal passed

    Posted 20-Mar-2023 03:58

    With the publication in the EU Official Journal today, the MDR extension has effectively entered into force. 

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC

    The regulatory text of the MDR extension was not changed from the original proposal even though >200 comments had been received during the request for comment period. 

    It is a pity because there appears to be more questions than answers i.e. the use of expired MDD certificate - cannot be extended legally - for other non-EU registrations. 

    In addition, many manufacturers may now assume that they can wait with MDR application not knowing of all the conditions attached for qualifying for the extension. 

    The long length and the not simple written text of the MDR extension - leading to different interpretations - is also unfortunate. 

    Hopefully, those countries who spoke during the last meeting on March 14th (see previous post with link to video) will push for further changes to the MDR. 

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------