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  • 1.  EUDAMED delay 2 years

    Posted 30-Oct-2019 09:45
    It is being reported that the EUDAMED database implementation will be delayed up to 2 years.  For you EU MDR experts, does this have any impact on the May 26, 2020 MDR date?

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    Mac McKeen, RAC RAC, MBA
    Fellow, Regulatory Science
    Maple Grove MN
    United States
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  • 2.  RE: EUDAMED delay 2 years

    Posted 30-Oct-2019 10:40
    No. The regulation applies from 26 May 2020.​

    The possibility of a EUDAMED delay was foreseen. Article 123, point 3(d), contains a list of provisions that won't apply until after full functionality is declared.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: EUDAMED delay 2 years

    Posted 31-Oct-2019 03:20
    This will certainly give manufacturers more time to get systems in place and be ready when EUDAMED finally goes live. 

    But it does NOT alter the transitional dates for enforcement of MDR/IVDR 

    There are a whole lot of other provisions relating to things like registrations and filing of reports into EUDAMED which do get delayed.   But you still have to prepare the reports and file with your Notified body.    The detail is at Article 123 in MDR here

    The article 29 provisions on notification of UDI numbers into EUDAMED get delayed too, but you still have to have a UDI according to current roll out.

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    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
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    Original Message


  • 4.  RE: EUDAMED delay 2 years

    Posted 31-Oct-2019 05:41
    Some clarifications probably are necessary. The EUDAMED database exists currently. I believe what is being delayed is some of the functionality. For instance, the electronic reporting of adverse events by manufacturers into the database could be delayed, but reports will still need to be made and could be uploaded by the competent authorities for sharing. 

    The ability of manufacturers to query the system may be delayed, but competent authorities would still have access (the same as they do today). 

    While this affects the processes at manufacturers, we need to be aware of the development and use of these by regulators as well. If someone could provide additional clarity (wouldn't that be nice for all of these changes?) that would be helpful to the whole community.

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


  • 5.  RE: EUDAMED delay 2 years

    Posted 31-Oct-2019 06:44
    The delay to May 2022 in now official see https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
    Read the section What is the state of play of the implementation of EUDAMED?


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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 6.  RE: EUDAMED delay 2 years

    Posted 31-Oct-2019 07:21
    Thanks Dan. This does add some of the explanation. The EUDAMED database (Eudamed2) does currently exist under the Directives (MDD, AIMDD, IVDD), but has VERY limited capability and really no manufacturer responsibilities. It is only accessible by competent authorities and the EU commission.

    The new EUDAMED will greatly expand this current database. 

    From the link that Dan posted...."The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable."

    They ask us to spread the word here: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/spread-word_en


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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


  • 7.  RE: EUDAMED delay 2 years

    Posted 31-Oct-2019 09:05
    Thanks Mark this is very timely and helpful. Thanks for keeping us all up to date.

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    Mac McKeen, RAC RAC, MBA
    Fellow, Regulatory Science
    Maple Grove MN
    United States
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    Original Message


  • 8.  RE: EUDAMED delay 2 years

    Posted 01-Nov-2019 04:36
    I am not sure some of are completely surprised by this news ...

    It is just unfortunate because from reporting vigilance activities, this would have been very helpful for companies to have a singular place for reporting.  Now manufacturers have to continue the "decentralised" methods for vigilance reporting as have been doing under the Directives - which luckily systems are in place, but streamlining and efficiency these days is a positive step.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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