Episode 36 – How to choose your PRRC with Erik Vollebregt

Medical Device made Easy Podcast · Aug 12, 2019

You will hear the acronym PRRC more and more as with the new Medical Device Regulation MDR 2017/745 and IVDR 2017/746 it is mandatory to have one at your company.

But what does it mean? This means Person Responsible for Regulatory Compliance. It will be a key person on your organization and you cannot appoint anybody at this role.

To help you understand what are the requirements, Erik Vollebregt from Axon Lawyers and myself will review with you the last guidance issued by MDCG. There is some clarification but there is still some unknown.

So, if you want to be compliant with the MDR, you need…