Remember what I said about MDR no longer being legislation but interpretation? Here’s another example for you:
My team is currently stuck on the seventh level of hell, trying to get a Class I device registered for a client.
The European Authorized Representative (EAR) has indicated that one Person Responsible for Regulatory Compliance (PRRC) is not sufficient, and that manufacturers also need a back-up.
This back up PRRC must meet the same exhaustive list of qualifications as the primary – and this when manufacturers and notified bodies alike are competing for a dwindling pool of qualified candidates.
And if a manufacturer can’t provide or hire a backup PRRC, then they need to show proof that they have retained an external consultant or other resource to meet the requirement.
I pushed back a bit, asking the EAR where their “recent interpretation” of the PRRC requirements came from, they had the audacity to copy and paste the full text of MDR for me as a hyperlink, along with a rather pointed reference to Article 15.
When I asked if the PRRC requirement was their own interpretation of “permanently and continuously available”, the EAR avoided a direct response.
As I’ve said before – you can’t make this stuff up.
Just another hoop for already stressed device manufacturers to go through as they wind their way through the MDR review and registration cycle.
The kicker? A different EAR from a different agency in a different country may not interpret the requirement the same way.
Unfortunately, the MDR madness doesn’t end there. Here are some other things to consider before pursuing your MDR certificate: https://leanraqa.com/sell-your-product-in-europe/
And don’t forget EUDAMED. You’ll need to register your device there, and that is not an easy process either. Richard Houlihan walks us through it: https://youtu.be/Z5tDh_NUOeY