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  • 1.  PRRC and MDCG 2021-25

    This message was posted by a user wishing to remain anonymous
    Posted 28-Oct-2021 11:21
    This message was posted by a user wishing to remain anonymous

    Hi ,

    Has anybody checked the transitional provisions MDCG 2021-25, with respect to Article 15 - PRRC , it mentions  'not applicable' for legacy devices . I had assumed , we needed the PRRC even for complying with the Article 120(3) provisions? Is that not correct?




  • 2.  RE: PRRC and MDCG 2021-25

    Posted 29-Oct-2021 07:19
    Yes, Anon, I believe MDCG 2021-25 provides a long-awaited and much needed practical interpretation of MDR Article 120 for legacy devices.

    If you read the requirements listed in MDR Article 15, you can see that few of them can be applied to legacy devices, because they use terms such as "obligations are complied with in accordance with Article 10(10)", or "the statement referred to in Section 4.1 of Chapter II of Annex XV is issued". These requirements can be met only if the device concerned is CE marked against the MDR or is involved in a pre-market clinical study in accordance with the MDR, so cannot be applied to legacy devices.

    However, if making vigilance reports to Eudamed for legacy devices, at that point the PRRC may need to be identified (see MDCG 2019-5 which states: "However, in case of serious incident or field safety corrective action to be reported during the 18 months referred to in point 1, where the legacy devices have not been registered in Eudamed yet, they must be registered at the moment of the serious incident/ field safety corrective action reporting").

    In addition, for non-EU manufacturers (of both MDR-compliant and legacy devices), when registering with Eudamed, they have to complete an Authorised Representative (AR) Mandate Summary, but you will note that identification of the AR's PRRC is not one of the required fields in the template.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Ltd
    UK Responsible Person services
    Christchurch, UK
    +44 1425 489208
    rgray@donawa.com
    www.donawa.com
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    Original Message


  • 3.  RE: PRRC and MDCG 2021-25

    Posted 01-Nov-2021 05:25
    Hello Anon,

    As Roger indicated the MDCG guidance was long-awaited and did provide some insight.  However, I would raise some caution when trying to separate in your organisation EU MDD and EU MDR products as during a quality system audit there are going to be challenges raised to you which should be prepared.  Probably the most important fact is the EU MDR came into force May 2017, yep that was over 4 years ago.  The idea being companies started planning, establishing, and implementing compliance 4 years ago, even with the 1 year reprieve not waiting until May 2021 or now to implement activities.

    Now, specifically the question about Person Responsible for Regulatory Compliance (PRRC) for legacy devices, the concept of PRRC is a quality system and product conformity aspect under Article 10.  This means post May 2021 there is a need for companies to have defined a PRRC.  The statement would then be raised: 'well we do not have any EU MDR products yet, because our certs expire March 2024.'  Very valid statement and you are probably ok.  Then bring in quality system requirements post May 2021 and Article 120 were activities like post market surveillance is required from a quality system perspective and by the MDCG.  Why I say use caution and may have some challenges, is there is inter-twining of PMS and a person responsible for regulatory compliance (did not capitalise for a reason).  This will be even more complicated if a company has some EU MDR products certified and still some EU MDD certified products because  we say, 'naw, there is no compliance responsible for those because they are still EU MDD.'  Not sure I would want to say that to an auditor.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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