Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019)

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
Version 1.22 (05-2019)

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.

Hi Marcelo,

Thanks for sharing the document. I am also looking for specific information on how the MDR devices classification will affect class I devices, and you might have the answer!

A current class I device under MDD which is a reusable surgical instrument, transient and invasive, would be maintained as class I? or will it be classified as class IIa?
Is there any devices classification database under the MDR where the GMDN codes can be checked?

Thanks,

Hi, just to make things clear, this question has nothing to do with the borderline document shared, right?

Anyway, reusable surgical instrument may continue to have the same class for the MDR (but you really need to review the classification), however, it now will require an evaluation by an NB of the reusable topic, together with a certificate issued by the NB previous to giving the device CE marking.

There's no device classification database under the MDR (nor under the MDD, i8n fact).