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    Time strategies

    Medical device manufacturers can use four basic strategies for the transition:

    Option 1 is required and/or recommended if you:

    ? Know your device is currently Class I self-certified, but will be NB-certified under the MDR

    ? Know your product is currently not considered a medical device, but will be an NB-certified device under the MDR

    ? Have sufficient clinical evidence for your device

    ? Have CE marking now and expect to make design changes in the next few years

    ? Are introducing a new device

    Option 2 is recommended if you:

    ? Plan to introduce new devices between 2020 and 2022

    ? Have sufficient clinical evidence

    ? Follow Annex IV of the MDD or AIMDD

    ? Expect your Notified Body will remain active in medical devices


    Option 3 is recommended if you:

     ? Have CE marking now but do NOT expect to make design changes in the next few years

    ? Need more time to gather clinical data needed for existing CE marked devices

    ? Don’t expect the classification of your device will change

    ? Are unsure whether you will be changing Notified Bodies

    Option 4 is recommended if you:

    ? Need to transition a wide variety of devices and do not have internal bandwidth to tackle them all at once

    ? Have a mix of devices: some with excellent clinical evidence, and others that need more data

    ? Are introducing new products in the next few years and working on recertification of existing legacy devices