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  • 1.  MDD to MDR Transition

    This message was posted by a user wishing to remain anonymous
    Posted 18-Mar-2019 08:52
    This message was posted by a user wishing to remain anonymous

    Hi,

    I have recently received a new CE Certificate based on the MDD Annex II with an expiration of Jan 2024.

    If the scope and product families do not change prior to 2024, do I need to revise the Technical File and related to meet the new MDR in 2020?

    Can I wait until 2022 to make the transition?

    Any advise is appreciated.

    Thank you


  • 2.  RE: MDD to MDR Transition

    Posted 18-Mar-2019 10:52

    At this point there is only one viable option, follow the Article 120(4) soft transition. It is unlikely that the EU will have all the mechanisms in place to allow a manufacturer to put an MDR CE Mark on a device before May 26, 2020.

    The soft transition involves the following elements:

    The device complies with the MDD

    There are no significant changes in the device or intended use

    The QMS implements the MDR requirements for post-market surveillance

    The QMS implements the MDR requirements for market surveillance

    The QMS implements the MDR requirements for vigilance

    The manufacturer registers in EUDAMED as an Economic Operator

    The manufacturer registers the device in EUDAMED (This includes populating the UDI database)

    When you update the QMS for PMS, then you will need to apply it to the devices. This means every device will need a PMS Plan and (except for Class I) a Periodic Safety Updated Report, PSUR.

    You should maintain the current technical file to demonstrate compliance with the MDD. However, create an additional section in the technical file to include the PMS Plan and PSUR.

    Notice also that the MDR Annex III includes information on trend reporting which is part of vigilance, so include that in the additional section.



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


  • 3.  RE: MDD to MDR Transition

    Posted 19-Mar-2019 03:32
    Hi,
    In addition to Dan's precise summary there is another strategic issue to consider.
    Your current NB must get designated under MDR and keep the product scope for your product or at least the NB must continue operations after May 2020 under MDD.
    The latter is not guaranteed as many NBs that do not request designation under MDR simply will drop the business of Medical Devices in May 2020 and then you have a problem because the Body that should execute surveillance for your CE cert under MDD disappears and with it your CE certificate.
    If you are with one of the major players this scenario should not happen but one never knows.
    Kindest Regards
    Michael

    ------------------------------
    Michael Maier
    Senior Partner
    Medidee Services
    www.medidee.com
    ------------------------------

    Original Message


  • 4.  RE: MDD to MDR Transition

    Posted 19-Mar-2019 20:28

    Michael,

    You had said, "Your current NB must get designated under MDR and keep the product scope for your product or at least the NB must continue operations after May 2020 under MDD".

    For the first part, can you explain why the NB for the soft transition must be designated under the MDR and maintain the product scope?

    I had inferred, based on Article 120(3), second paragraph that the soft transition uses the MDD NB, because that is the NB that issued the certificate for the soft transition. The text is "Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified."

    For the second part, there is a general problem that some MDD NBs will not be MDR NBs. This creates orphan manufacturers. Some MDD NBs have already stopped operations.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 5.  RE: MDD to MDR Transition

    Posted 19-Mar-2019 06:11
    Excellent detail from previous contributors .... I would just add some thoughts of my own:
    - although your MDD certificate may be legal, will competitors with an MDR certificate have a commercial advantage?
    - can you really avoid any change needing a change of wording on the certificate for four years?
    - don't forget the other economic operators who did not need to register under MDD, will need to under MDR e.g. distributors, servicing sites etc

    FYI we have already seen at least one manufacturer who has self-declared a class I medical device under the MDR using this in his sales pitch!

    Neil

    ------------------------------
    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 6.  RE: MDD to MDR Transition

    Posted 19-Mar-2019 21:00

    Neil,

    You asked if a manufacturer could avoid changes that affect the MDD certificate for four years. In many cases the medical device is mature, so significant changes are rare. More importantly, the soft transition is only a transition. The expectation is that during the transition the manufacturer would obtain an MDR CE Mark. I think (I hope) that few manufacturers would need the full soft transition period.

    Registration of economic operators is an issue. First, there are six kinds of economic operators, but only three of them must register with the EU: manufacturer, authorized representative, and importer. (One could argue that the two Article 22 economic operators are manufacturers, but it is not explicit in the MDR.)

    Distributors do not register with the EU following Article 30(1) and Article 31. However, following Article 30(2), "Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory".

    It appears that the manufacturer, authorized representative, and importer registration is uniform across the EU, but distributor registration is based on Member State and product distributed – no unified system.

    Also, I do not see a requirement for servicing sites to register with either the EU or the Member State. Have I missed it?



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 7.  RE: MDD to MDR Transition

    Posted 20-Mar-2019 16:06
      |   view attached
    There is a transitional provision FAQ from CAMD that has been out since 2017 of interest to this discussion and focuses on Article 120 Transitional Provisions among other issues.  See attached.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 8.  RE: MDD to MDR Transition

    Posted 19-Jun-2019 14:15
    Hi all,

    Thank you for this information about the MDR transition.  Does anyone have a "plain language" summary of the MDR transition language?  It's so convoluted in the MDR that it is difficult to understand which requirements go into effect in May 2020 and which can be deferred if one has an existing MDD certificate that doesn't expire until after May 2020.

    Thanks,
    Julie Broderick

    ------------------------------
    Julie Broderick RAC
    Principal/Consultant
    Winchester MA
    United States
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    Original Message


  • 9.  RE: MDD to MDR Transition

    Posted 19-Jun-2019 18:09

    This is actually the most simple part of the complicated mess. See Article 120(3).

     

    You must have a valid MDD certificate

    Your MDD Notified Body agrees to be your NB during the transition

    You implement the PMS system in Chapter VII Section 1 and the associated annexes

    You implement the vigilance system in  Chapter VII Section 2 and the associated annexes

    You implement the MS system in Chapter VII Section 3 and the associated annexes

    You implement the device registration in Article 29 (There is an MDCG guidance that says the UDI portion does not apply until the UDI dates in Article 123.)

    You implement the economic registration in Article 30

    You don't make a significant change in the device design

    You don't make a significant change in the device intended purpose



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


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