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

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 1,782 files are underway at notified bodies. But 17,383 product files have yet to be submitted by manufacturers