MDR compliance recommendations


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