- The European Commission designated two additional notified bodies under the incoming medical device regulations, according to information posted Monday in the EU's latest 'rolling plan,' but just one of the notified bodies has been publicly identified so far.
- Each country's competent authority is charged with naming the designated notified body on NANDO, the public database. So far, only BSI UK and TÜV SÜD Germany, which received designation previously, are listed.
- The announcement of the second organization designated and whether it was designated under the EU Medical Device Regulation or the In Vitro Diagnostic Regulation is expected before the end of this month.
The medical device industry has been on edge about capacity issues ahead of the European Medical Device Regulation's May 26, 2020, effective date, so Monday's news the European Commission designated two additional notified bodies is welcome.
"They will be announced before the end of August; that's all I have," Richard Houlihan, the CEO of Eudamed.eu in Brussels told MedTech Dive.
The EU MDR is designed to ramp up stringency and breadth of pre- and postmarket review infrastructure. But the designation of EU notified bodies, which are responsible for certifying medical products under the new regulation, has lagged behind and several notified bodies have exited the sector, stoking fears there won't be adequate capacity to deal with the new regulation's requirements. The IVDR comes into effect in May 2022, two years after the MDR.
"This is what was expected from the EC for weeks now," Jerick Parrone, senior manager of communications for MedTech Europe in Brussels, told MedTech Dive.
The two additional designations bring the total of notified bodies designated under the new rules to four, well below the 20 the EC reportedly has said it expects to be designated by the end of the year.