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  • 1.  Animal Medicinal Substances and GSPR

    Posted 08-Jan-2020 18:08
    Hello,

    For our Class I devices that are intended to come into contact with intact skin only we have been using 2003/32/EC Article 1 (4) as justification for exempting ourselves from 8.2 of the MDD Essential Requirement. My question: Is this Directive (2003/32/EC) still applicable for Article 13 of the GSPR in the EU MDR? 2003/32/EC references the MDD and I have not found another directive or guidance that would exempt devices that are only intended to come into contact with intact skin.

    Thanks in advance!

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    Alena Newgren
    Regulatory Manager
    United States
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  • 2.  RE: Animal Medicinal Substances and GSPR

    Posted 08-Jan-2020 19:24

    I think you need to be very careful in your reasoning under both the MDD and the MDR.

    Under the MDD, Annex I(8.2) applies to all devices utilizing tissues of animal origin. It does not have a caveat concerning intact skin. I believe it applies to your device. The method to demonstrate conformity implements the members of the EN ISO 22442 family. I agree that 2003/32/EC Article 1(4) tells you that 2003/32/EC does not apply. It does not provide an exemption to MDD Annex I(8.2).

    For the MDR Annex I(13.2) is the applicable requirement. Annex I(13.2)(a) and (13.2)(b) typically involve members of the EN ISO 22442 family. For Annex I(13.2)(c) you need to analyze Regulation (EU) No 722/2012. In any case, I don't believe that 2003/32/EC provides an exemption to MDR Annex I(13.2).



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


  • 3.  RE: Animal Medicinal Substances and GSPR

    Posted 09-Jan-2020 07:47
    I would have to agree with Dan as appears you are using text or exemptions from one Directive to apply for a completely separate Directive/Regulation.  The Directive you are citing 2003/32/EC is for products containing tissues of animal origin; this does not apply to medical devices in general.  Therefore, if you are talking about your Class I device, it would have to contain tissue of animal origin in order for that Directive 2003/32/EC to be applicable.  If your device is just a Class I device with no tissue of animal origin, then coming into contact with intact skin you would want to apply ISO 10993 for biocompatibility using a risk based approach - up to creating a biological evaluation report for your device.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Animal Medicinal Substances and GSPR

    Posted 09-Jan-2020 09:40
    Hi Richard,

    Thank you for your response. Our devices do not contain tissues or bi-products that we know of and it is not called for in any specifications. Our issue lies in obtaining certifications from all off-the-shelf suppliers if their product may come into contact with animal bi-product or contains any. We do have our risk-based ISO 10993 tests completed for patient contacting components (cyto, sensitization, intracutaneous injection typically).

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    Alena Newgren
    Regulatory Affairs Manager
    North Liberty IA
    United States
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    Original Message


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