Regulatory Open Forum

 View Only
  • 1.  Transition Timelines for MDR

    This message was posted by a user wishing to remain anonymous
    Posted 07-Dec-2020 09:03
    This message was posted by a user wishing to remain anonymous

    Does the one-year extension on when MDR fully applies extend out to devices currently with MDD certificates?

    Looking at this link, https://ec.europa.eu/docsroom/documents/34907/attachments/1/translations/en/renditions/native, if I have CE Mark currently, with the one-year extension, I have until May 2025 to obtain my MDR certification? And, devices on the market prior, can continue to be on the market until May 2026?


  • 2.  RE: Transition Timelines for MDR

    Posted 07-Dec-2020 12:11
    Hi anon, the one year delay of the date of application did not lead to an extension of the 2020-2024 period at the end with one year. So 26 May 2024 is still the date before which all devices need to be CE marked under the MDR, see also the amended overview on the Commission site: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/timeline_mdr_en.pdf

    ------------------------------
    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
    ------------------------------



  • 3.  RE: Transition Timelines for MDR

    Posted 07-Dec-2020 13:41
    Edited by Kevin Randall 07-Dec-2020 13:50

    In short, the answer is no, the one-year extension of the MDR's date of application does not extend the validity dates of certificates issued under the MDD; and does not extend the date for allowing devices already on the market to remain on the market.  Adapting the outdated infographic can be tricky, so I would recommend instead referring directly to the corresponding Article 120 transitional narratives in the latest consolidated version of Regulation 2017/745, as updated by the 27.12.2019 Corrigendum and the Regulation 2020/561 COVID-19 revisions. 

     
    Here's a recap:

     

    • First, don't forget that, pursuant to Article 120(2), MDD certificates issued prior to 25 May 2017 are only valid until the certificate's expiry, whatever that date may be, except for MDD type-examination certificates, which are voided at the latest on 27 May 2022.  So, the subject devices of such certificates may not be placed on the market after such expiry dates.  Be aware that for those devices, the certificate expiry date may very well be earlier than the 26 May 2024 date mentioned in my narrative below; so be careful not to apply the 26 May 2024 date too broadly.
    • And for MDD certificates issued 25 May 2017 and later, those too are valid until the certificates' expiry, except that those in any event shall become void at the latest on 27 May 2024 (not 2025).  Again, the subject devices of such certificates may not be placed on the market after such expiry dates.
    • Article 120(3) reiterates/reminds us that MDD-certified devices may not be placed on the market or put into service after 26 May 2024, while also expanding that liberty to include MDD self-declaration class 1 devices that under the MDR will require certification / notified body intervention.
    • Note also that, to determine how long devices already placed on the market before 26 May 2021 are allowed to remain on the market, the aforesaid 26 May 2024 date and Article 120(2) and (3) provisions do not apply.  Instead, for that we need to apply Article 120(4) (the so called "sell-off" provision), which establishes that those devices may continue to be made available on the market or put into service until 26 May 2025 (not 2026). Further Forum explanation/discussion about that can be found here in a recent Forum thread.


    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------