With less than one year before the EU’s Medical Device Regulation takes effect, an industry group is sounding alarms about the lack of “essential guidance” and the shortage of notified bodies needed to certify products in compliance with the new requirements.
“[V]ery little progress has been made in the implementation of the regulation,” says the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) said in a new position paper. “Our members have invested considerable resources to be prepared for the MDR, but only as far as possible considering essential guidance information is still missing.”
So far, only two notified bodies — BSI and TUV SUD — have been designated under the MDR, and “there is no indication that a significant number of notified bodies will be designated in the next months,” COCIR said, adding that this is far short of the number needed to accommodate devicemakers.
Among other recommendations, the committee suggests that devicemakers that participate in the International Medical Device Regulators Forum Medical Device Single Audit Program (MDSAP) should not have to undergo notified body certification.