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  • 1.  EU MDR - Person Responsible for Regulatory Compliance

    Posted 04-Oct-2019 16:47

    Hello

    Is it possible to have more than one Person Responsible for Regulatory Compliance, especially when the responsibilities are split between departments, such as RA and QA at the same manufacturer? Article 15(4) states the following:

    'If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.'

    Am I correct in interpreting this as having more than one 'persons' responsible for regulatory compliance as long as their areas of responsibility are documented?

    Thank you.



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    Maham Ansari RAC
    Director, Regulatory Affairs
    Canada
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  • 2.  RE: EU MDR - Person Responsible for Regulatory Compliance

    Posted 04-Oct-2019 18:27

    Yes, a manufacturer may have more than one person responsible. I recommend it. You could, for example, have two with the same responsibilities to cover for vacations, etc.

    If you split the responsibilities, then you should be clear about the split. I recommend a formal notice of appointment from "Top Management" using the ISO 13485:2016 definition.

    If you implement FDA's QSR, then I recommend you document the appointment and the split responsibilities in 820.186 Quality System Record. It is designed for such information.



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


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