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

[Image courtesy of Google Satellite]

The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is trying to become friendlier to innovators.

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.

Go to our sister site Medical Design & Outsourcing and listen to MDO’s latest podcast as Drues takes a dive into what the MDR means and how medical device companies can strategize around. 

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