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  • 1.  Clinical Requirements Under EU MDR for Medical Refrigerators

    Posted 26-Feb-2021 19:49

    I have an opportunity to partner with another consultant to do a pre-EU MDR/IVDR internal audit for a small company that makes medical refrigerators (I don't know yet if they also make medical freezers). The total revenue billed for will be small; probably $20,000 between us.

    I would love to gain this experience but need some helpful guidance from the community. 

    From a clinical evidence perspective:

    (I)  What types of clinical outcomes should be gathered for approval under the new EU regulations?

    (II) What types of PMCF studies should be performed, e.g., hypothesis testing, powered surveys?

    I really appreciate some brief pearls of wisdom here.

    Respectfully submitted,
    David R Rutledge

    PS. I love doing new things and so I genuinely want to thank you in advance.



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    David Rutledge PharmD
    Mountain View CA
    United States
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  • 2.  RE: Clinical Requirements Under EU MDR for Medical Refrigerators

    Posted 28-Feb-2021 05:18
    Dear David,
    Under MDD and MDR Blood and Biologic Refrigerators are classified as IIa Medical devices. A number of manufacturers have MDD certification but I know of only one with MDR certification. TüV Sud was the Notified Body in all cases. I suggest you contact them on the clinical requirements.
    Kind regards,
    Phillip





















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    Phillip Storey
    Managing Director
    Rotterdam
    Netherlands
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    Original Message


  • 3.  RE: Clinical Requirements Under EU MDR for Medical Refrigerators

    Posted 29-Jul-2021 09:25
    Hello David,

    I came across your post whilst looking for some information on clinical evaluation... What an interesting project!

    Can you share what the clinical requirements were for medical refrgerators, purely out of curiosity? 

    Kind regards,
    Thomas

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    thomas morrison
    Q&RA Officer
    PARIS
    France
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    Original Message


  • 4.  RE: Clinical Requirements Under EU MDR for Medical Refrigerators

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2021 08:43
    This message was posted by a user wishing to remain anonymous

    These devices come under Article 61 (10) clinical data is not deemed appropriate. The CER should make reference to bench tests and validation studies. A literature search should be conducted to demonstrate no safety concerns are identified or zero results returned.
    Original Message


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