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  • 1.  PRRC

    Posted 06-Mar-2024 04:06

    Can PRRC being based outside of the EU, where the LM based in the EU? 



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    Larisa Caplin
    Senior Regulatory Affairs Specialist
    Church and Dwight, Inc.
    Folkestone
    United Kingdom
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  • 2.  RE: PRRC

    Posted 06-Mar-2024 13:15

    Hi Larisa,

    as far as I know there is no direct requirement in the MDR to this effect. However, MDCG 2019-7 adresses this question and states:

    "It is important that a close linkage of a permanent and continuous nature is established between the PRRC and the manufacturing activities. For this reason, for manufacturers located outside the Union, it must be assumed that the PRRC should also be located outside the Union. On the other hand, for manufacturers located in the Union, it must be assumed that the PRRC should also be located in the Union."

    Therefore I think it is unlikely that this would be accepted (except maybe in cases where you could argue that Union and non-Union territory are so close that it makes no difference).

    Best regards, Christoph.



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 3.  RE: PRRC

    Posted 07-Mar-2024 04:58

    Hello Larisa,

    Christoph provided the good information in reference to the guidance document MDCG 2019-7 providing information beyond the regulation; just note there are some inconsistencies between this guidance and the regulation.  Also there is a wide interpretation of roles and responsibilities of a Person Responsible for Regulatory Compliance (PRRC) by Notified Bodies.  The "intent" of a PRRC is being the most responsible individual(s) for product compliance and quality system compliance which should be directly linked to the (legal) Manufacturer.  Therefore, as Christoph quoted assumed the PRRC is located outside the Union - associated with the Manufacturer.  If the PRRC is physically located somewhere else than with the Manufacturer, this should be clearly described with some wording around why this may exist.  As an example, multi-country/multi-site organisations may have the manufacturing plant located in Country A, post market operations in Country B, and quality/regulatory in Country C.  It must be made clear how the relationship between the different sites and the PRRC being responsible for those activities, awareness, and roles under the EU MDR/EU IVDR.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 4.  RE: PRRC

    Posted 07-Mar-2024 08:32

    Yes, as long as the PRRC is based in the Union (see the other answers with reference to the applicable MDCG guidance).

    So, if the manufacturer is based in the EU, then the PRRC can still be based in Norway, Iceland, Liechtenstein or Turkey - which are all Union but not EU.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 5.  RE: PRRC

    Posted 07-Mar-2024 08:55

    Ok, so if the LM in EU, can PRRC being based in UK? 

    Second scenario: LM is outside of the EU, can PRRC be based outside of the EU?



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    Larisa Caplin
    Senior Regulatory Affairs Specialist
    Church and Dwight, Inc.
    Folkestone
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: PRRC

    Posted 07-Mar-2024 09:06

    First scenario: no, because the UK is not Union. Union (as per article 1 MDR) are all EEA member states plus Turkey - these are all the countries in which the MDR applies (see the Blue Guide for detailed explanation). The UK brexited to make the UK great again without EU legislation. The Swiss called the EU's bluff on not extending the medical devices MRA and are now in the same boat (i.e. outside of the Union). 

    Second scenario: yes, LM can be outside EU but in Union (e.g. Turkey) and PRRC can be outside EU but in Union (e.g also in Turkey). For LM outside of Union see the MDCG 2019-7 Rev. 1 guidance: also then the PRRC can be outside of Union, provided that there is a close link to production.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 7.  RE: PRRC

    Posted 07-Mar-2024 11:11

    Hi Larisa,

    to add some additional considerations to Erik's answer: This is true if you strictly follow the example in vs outside the Union that is given in the MDCG 2019-7. However, this still is only a guidance, the MDR itself makes no clear requirement on the location of the PRRC but on their availability (e.g. "permanently and continuously at their disposal" for external PRRCs in the case of micro or small enterprises) and their responsibilities as Richard pointed out. And as an anonymous contributor later pointed out MDCG 2019-7 adds additional context in footnote 7 and 9: "Given 'outside the Union' is a large geographical territory, the PRRC's location is recommended to be e.g., in physical and geographical proximity to the manufacturing activities." 

    So for your first scenario: If the LM is based in Ireland (inside the Union), then a PRRC based in UK (even though outside the Union) might be acceptable, whereas a PRRC based in eastern Poland (even though within the Union) might not.

    And for the second: If the LM is based in Switzerland (outside the Union), then a PRRC based in Germany (even though inside the Union) might be acceptable, but a PRRC based in Australia (even though outside the Union) might not.

    This all of course with additional consideration of the type and associated risks of the devices, the LMs organization and the actual implementation of the PRRCs responsibilities.

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 8.  RE: PRRC

    Posted 12-Mar-2024 07:59
    Edited by Larisa Caplin 12-Mar-2024 08:00

    Thank you for your help.

       



    ------------------------------
    Larisa Caplin
    Senior Regulatory Affairs Specialist
    Church and Dwight, Inc.
    Folkestone
    United Kingdom
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    Original Message


  • 9.  RE: PRRC

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2024 09:04
    This message was posted by a user wishing to remain anonymous

    To add to what Christopher provided, this also applies to micro or small enterprises:

    "For micro or small enterprises located in the Union, it must be assumed that any person to be permanently and continuously at their disposal should be also located in the Union. For manufacturers located outside the Union, it must be assumed that the PRRC should also be located outside the Union9."

    "9 Given 'outside the Union' is a large geographical territory, the PRRC's location is recommended to be e.g., in physical and geographical proximity to the manufacturing activities."

    Depending on the device classification, if you have a Notified Body, you could try asking them for their feedback regarding this scenario.


    Original Message


  • 10.  RE: PRRC

    Posted 13-Mar-2024 04:04
    Edited by Ronald Boumans 13-Mar-2024 04:13

    Let me throw in two points into this discussion:

    1. The MDR/IVDR do not make a distiction regarding inside or outside the EU in Article 15. The requirement is that a company must have a PRRC 'within their organization'. The word 'organization' is not specified and therefore be seen as people working on a common objective. It is not necessarily a geographical concept, although the MDCG is holding on to this. They should be aware because TEAM PRRC has raised this point repeatedly in their discussions with the MDCG about the revision of the guidance.
    2. Keeping the social perspective in mind, having a PRRC within an organization may require that PRRC to be based in- or outside the Union, regardless of the formal address of the legal person. Some examples:
      1. A large corporation has all their regulatory work, including all the in-country representation affairs at their headoffice. The addresses of the various in-country representative legal persons in all their global markets are usually found at the marketing/sales headquarters in those markets and consist of a small corner of a desk. All the RA work is done at their global headquarters. It would make perfect sense if the PRRC would be based in those headquarters; it would actually make their work almost impossible if they would work from those remote desks. By the way, this is a realistic scenario that I have seen with three global companies. 
      2. An EU based legal manufacturer has a production plant outside the EU. They want to appoint a PRRC specifically for production. It would make perfect sense if that PRRC would be based in that production plant, outside the EU; it would actially make their work almost impossible if they would be working from their EU legal manufacturer address. By the way, this is a realistic scenario that I have seen with several European companies and I have recommended them to appoint the PRRC remotely. So far, the authorities did not raise this issued and their notified bodies also appear to fine with this.
      3. A manufacturer has their production plant in France, near the Swiss border, and their headoffice in Switzerland, near the French border. I guess you can fill in how I have recommended they should do this, and what their notified body thought of that. 

    Regarding the UK as a base for the PRRC, while the legal manufacturer is based in the EU we have to apply the same rationale: where is the action? I think, the authorities will appreciate a PRRC based at the headquarters or in the production plant, rather than entertaining the inside of their nose, while sitting at a lonely desk in France at the official address of the legal manufacturer, while their British colleagues are enjoying themselves with all sorts of activities that may affect the compliance of the devices. It is all about creating the right justification. 

    In short: the PRRC should be based where the action is. That is, in my view, how 'within their organization' should be understood. So far, notified bodies and competent authorities agree with this. If anybody has a different experience, please let me know. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


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