ARTICLE SUMMARY:
A new study highlights notified bodies’ divergent interpretations of what data is needed to satisfy EU clinical evaluation requirements for well-understood, moderate-risk devices. Researcher and consultant Elisabeth Oltmanns is working to elevate the role of clinical judgement and, in particular, non-clinical data in the MDR.
Medtech clinical consultant Elisabeth Oltmanns reached out to multiple notified bodies recently to support a research study on EU regulatory expectations for devices, but it didn’t go as expected.
“I’ve been working with notified bodies, and I know that they’re slightly different in their opinions,” Oltmanns says. “Some are more concerned about certain details and some about others, but I’ve never thought it would be that much of a difference.”
She planned to conduct interviews with all 48 Medical Device Regulation-designated notified bodies (at the time; there are currently 50) to ask them about what an appropriate MDR clinical evaluation strategy would be for a hypothetical device, specifically, a laparoscopic insufflator, which is a well-established type of Class IIb product that employs carbon dioxide gas to distend the abdominal cavity for laparoscopic surgery. But she soon reconsidered the approach.
