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...
Lugan and industry colleagues stressed the negative consequences of not addressing the EU system’s suboptimal notified body coverage and general lack of readiness. He suggested routes that would make the...