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  • 1.  EU MDR Extension

    Posted 13-Mar-2023 21:36

    Hello all,

    With the possible EU MDR Extension, I would like to confirm the following:

    1. Do we need to apply for the renewal of the EU MDD certificate if the EU MDD certificate is expiring before the MDR deadline?
    2. Can we do EU MDD change notification (if any) and EU MDR submission simultaneously? 
    3. Is the EU MDR extension only applicable to products for which EU MDR submission has been made?

    Thanks!



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    Shikha Malik
    Sr. Regulatory Affairs Specialist
    Frisco TX
    United States
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  • 2.  RE: EU MDR Extension

    Posted 14-Mar-2023 11:34

    Hello,

    as far as I can see and with some caution because the MDR extension is not yet formally published and probably needs some additional interpretation and clarification:

    1. Not directly. If the certificate expires after the entry into force of the extension, then the certificate is automatically extended to the applicable deadline for the respective device class. If the certificate expired before that date you need either a previously signed agreement with a notified body for MDR conformity assessment or a procedure in accordance with Article 59(1) or Article 97(1) in cooperation with a national authority. To be able to place devices on the market under this certificate, some additional provisions must be met (see e.g. your third question).
    2. As long as it is not a significant change according to Article 120(3) I assume this should work. You probably should communicate this clearly to your notified body to avoid confusion.
    3. To some degree. To be able to continue placing MDD devices on the market, no later than 26 May 2024 you must have lodged a formal application for MDR conformity assessment with a notified body and no later than 26 September 2024 a respective agreement must have been signed by both with respect either to the MDD device itself or for a device intended to substitute it.

    I hope that helps. Let me know, if you have additional questions.

    Best regards

    Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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    Original Message


  • 3.  RE: EU MDR Extension

    Posted 14-Mar-2023 13:57

    Shikha,

    Second and support what Christoph wrote because while the PROPOSAL was voted on and agreed, the actually implementing regulation is yet to be published in the Official Journal.  Many thought because they would fast-track this through the process it would have been published by now.  Whether the proposal and the text in the official publication is the same, is yet remaining to see.  It was stated the 20 day implementation time would be waived so when the regulation is published in the Official Journal it would become effective on that date.

    You can read the proposal here to get an idea on answers to your questions, but Christoph provided a good overview https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2023/0010/COM_COM(2023)0010_EN.pdf.  There are many "devils in the details" which might not be fully answered, but if your product has already been "placed on the market" there are some caveats to understand as mentioned above.  The current issues arise where companies EU MDD certificates were expiring in the last few months or upcoming couple months; there needs to be an application in place with a Notified Body.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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