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Research use only

Discussion in 'EU Medical Device Regulations' started by HS330, Dec 16, 2016.

  1. HS330

    HS330 New Member

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    We have a device which has been certified as a class 2a medical device for several years based upon our original intended use. We have subsequently found that the device has never been used for medical benefit or in clinical applications. Can we legitimately claim that the device is for 'research use only' and 'not for clinical use' and hence drop the class 2a designation?
     
  2. Vintage Goose

    Vintage Goose Active Member

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    We had a similar issue where the MHRA instructed us to remove the CE Mark as they did not consider our products to be medical devices. Dropping the CE Mark is certainly possible, just be sure everyone understands what you are doing and why; especially Sales & Marketing, and also your customers.

    I would suggest going through a documented assessment process of whether the products meets the requirements of a Medical Device under the MDD and if not, having a discussion with your notified body to confirm it. Also check any competitor products; do they meet the MDD.

    Chris
     

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