Europe’s new MDR: Is it as scary as you might think?

The European Union’s regulation of medical devices appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off.

In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside Boston.

In the E.U., for example, a predicate device in an application under the new MDR is going to require access to technical design and performance specifications. That is not the case in the U.S. Under the MDR, more device submissions will require pre-market clinical evidence. The situation is opposite in the U.S.

The new MDR has a word count that’s nearly four times higher than the previous version, with five more annexes. It uses the word “safety” 290 times, compared to 40 times in the past version.

And more regulation doesn’t always make sense, according to Drues. “Of the regulations that we have, does it make sense? What does it accomplish in the real world?”

Listen to Medical Design & Outsourcing’s latest podcast as Drues takes a dive into what the MDR means and how medical device companies can strategize around it.