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  • 1.  Mutual acceptance of clinical data in under EU MDR ?

    Posted 07-Jun-2022 21:23
    Hi everyone, 

    I wanted to clarify to what extent clinical data from other jurisdictions can be used to satisfy the clinical investigation requirements under the EU MDR. Can data collected in US/Canada be used to obtain the CE mark? If somebody has experience with clinical investigations in the EU as a foreign manufacturer, any advice would be appreciated.

    Thank you.

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    Karen Zhou
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  • 2.  RE: Mutual acceptance of clinical data in under EU MDR ?

    Posted 08-Jun-2022 01:38
    Hello Karen,

    I worked with a couple where one we were able to use clinical data from a United States site study which was fine for the clinical data.  The other one needed to be in Europe based on the patient population, but more importantly the surgical procedure because there were different approaches in different parts of the world (it was a Class IIb).  Have to give the regulatory answer of it depends - on the device type, clinical application, patient population, where it is used (professional versus private environment), etc.  What we found as part of the clinical evaluation and clinical study plan (protocol) is having a good, well thought out, and supportive decision for the site selections, specifically which country or region they are located.  If the device is not too dependent on type of patient or conditions of use, then other regions might be acceptable.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Mutual acceptance of clinical data in under EU MDR ?

    Posted 08-Jun-2022 13:43

    Yes, clinical data collected anyway can be used for CE mark provided the study meets ISO 14155 or equivalent

     

    Sent from Mail for Windows

     




    Original Message


  • 4.  RE: Mutual acceptance of clinical data in under EU MDR ?

    Posted 09-Jun-2022 13:05
    Hi Karen,

    We submitted US clinical trial data in support our MDR application. During the MDR application review, the NB reviewer asked us to provide analysis that relates the US trial data to an EU population, including how standard of care might differ between the regions, and also asked us to show compliance to ISO 14155. We demonstrated that the US subjects were of mostly European extraction through presentation of our subject demographic data. We compared standard of care by summarizing (at a very high-level) the principle US and EU medical society guidelines and discussed how the societies collaborate with each other. Compliance to ISO 14155 was demonstrated through Annex A compliance checklist.

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    Mark Mortellaro
    Sr. Principal Regulatory Scientist
    Clarksburg MD
    United States
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    Original Message


  • 5.  RE: Mutual acceptance of clinical data in under EU MDR ?

    Posted 09-Jun-2022 15:22

    Hello Karen,

    With the increased clinical evidence expectations for EU MDR, it is wise to consider how your clinical evidence can be applied to other geographies. Most countries require some type of evidence of safety and performance/effectiveness for the device when used as intended in the correct patient population.  Key considerations when determining whether or not data from a study can be used to support a submission in a specific geography are the patient population and medical practice. Some countries, especially US, EU and Japan, are very particular and require justification for why the data for the study's patient population is applicable to their country's population. You also need to ensure that the practice of medicine for the study would be applicable to the country so that the results can be applied.

    To your specific question, provided the study was well conducted and you have a representative patient population, the US/Canada data should be usable for a CE submission. Be sure to provide a justification of the applicability in your application.

    Should you require additional information, please reach out. My team is very knowledgeable in clinical, regulatory and quality affairs.

    Best regards,



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    Karen Bannick McQuoid MA, FRAPS, RAC, FRAPS
    CEO
    karen@bannickprimary.com
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    Original Message


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