The first-ever Medical Device Regulation expert panel opinion wasn’t shy in spotlighting evidence gaps for a dental graft device, making clear that robust claim-specific evidence is the rule of the day under the MDR. The notified body requested the European Commission to take the opinion down from its website, and the Commission has at least temporarily complied, hinting at the new public pressures for the panel process. We spoke to MDR expert Bassil Akra.
The new EU expert panels under the Medical Device Regulation will not be a rubber stamp for companies seeking CE marks for new higher risk devices. That much was made clear in the first-ever MDR panel opinion, which was publicly posted in early July (and subsequently has been taken down at the request of the notified body). The opinion cast doubt on much of the evidence that was reviewed by a notified body for a dental bone graft device, calling into question the planned certifications for all but, potentially, one of seven indications that were sought by the manufacturer.
The expert panel process is a novel element of the MDR (and upcoming IVDR) that didn’t exist for the legacy EU directives. Historically, an individual notified body’s conformity assessment is the last word in a device’s journey to certification. But MDR added this panel review step for select devices as an extra assurance that devices on the market are supported by evidence. It is the farthest Europe has moved toward a more EU-centralized review for devices.