Regulatory Open Forum

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  • 1.  Test Lab Accreditation

    This message was posted by a user wishing to remain anonymous
    Posted 17-Apr-2018 10:49
    This message was posted by a user wishing to remain anonymous

    Recently my company has been asked to include test lab accreditation (e.g. ISO 17025) along with test reports when submitting medical devices for some tenders in the EU. Do we foresee that the EU MDR will make this type of request a requirement for medial device registrations (not just tender bids) in the EU? Or at the very least, will this type of request become more commonplace due to the MDR? What are best practices for use of 3rd party test labs and are there cases when using an unaccredited labs would be acceptable?

    Thank you in advance for any recommendations or guidance.


  • 2.  RE: Test Lab Accreditation

    Posted 18-Apr-2018 06:25
    My personal opinion is this would be true that lab accreditation is going to be much more strongly required.  Already in places like U.S., Japan, and Brazil, providing certification for those testing labs that conduct performance testing, safety, testing, etc., require the company to identify the third party testing lab and include any certification.  Have also been aware (not me personally) where the regulatory agency inquired why the third party lab was not accredited and they wanted to see additional information on how the lab was qualified to perform the testing.  So yea, I think this will become the norm in EU with the new MDR as well.

    Richard Vincins RAC
    Vice President Regulatory Affairs