Better Late Than Never: German Medtechs Make The Case For Practical MDR Improvements

21 May 2021

A regulatory system that cannot function as intended, even with an extra year for preparation, will become mandatory in the EU next week. German medtechs suggest a route forward.

Some 181 certificates have so far been issued under the EU Medical Device Regulation. “That is the work of 12 months,” said BVMed chairman Meinrad Lugan, addressing a press gathering one week from the date the MDR will become mandatory.

The EU’s rates of file processing need to be ten times that level, he said, referring to statistics that show...