Transition legacy devices to MDR (novelty consideration)


Starting to get Involved
Does the “no grandfathering” rule regarding the MDR mean for MDD certified devices which will have to be re-certified under MDR compliance that:

With respect to the device description, annex 2, paragraph 1.1(g) regarding “novelty”, Legacy devices already a long time on the market can be seen as having “no novel features” as there are over time, currently more devices on the market available which have similar functionality?

I am wondering if this is the case as in my opinion, that statement (novel features or not) will affect the way of presenting clinical evaluation data or other aspects of presenting evidence of compliance to by example GSPR.

I hope my question is clear,

Thank is advance.

Best regards, Patrick


Starting to get Involved
I think that if you are claiming there are multiple devices (from various manufacturers) on the market with similar design components, then the component would not be considered novel. (Think in terms of State of the Art).
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