Class I Medical Devices under MDR with Erik Vollebregt (PART 2)

Medical Device made Easy Podcast · Dec 16, 2019

In this second part of the discussion with Erik Vollebregt, we will continue to help Medical Device manufacturers regarding the MDR Corrigendum 2. But we will also include more information about pure Class I devices.

The manufacturers with only class I devices will be surprised as there are also more requirements they have to follow per MDR. For example the creation of a QMS, the registration of economic operators, UDI…

So you should really understand those requirements as this can also increase the cost. I used the example of someone contacting me from the US to register an FDA class 1…