New MDR: Authorized Representative Requirements

[Jen C]

I'm curious if others are also already hearing from their EU authorized representatives that they may be closing that part of their business, or increasing the costs multifold. We knew this would be coming, but didn't expect there to be immediate effects; however, our AR is telling us that even though the regulation won't be applied until May 2020, because the regulation is already in force, these liability concerns could come up in legal cases at any time.

Is that everyone's understanding? Can the MDR be used now as legal basis for findings against an AR, even though it isn't yet applied?

 

[Access2hc]

it really depends on what liabilities you're referring to.

I just had my company's EU AR started 11 months ago, and at the end of the day pricing depends on the market, for the product. Life goes on.

one note is on post market data - start collecting else you would have not enough to show come May 2020.

Cheers,
Ee Bin
Access2hc