ARTICLE SUMMARY:
Notified bodies say they want to be more responsive to questions from companies planning MDR or IVDR submissions, but restrictions against consulting and a lack of clarity from EU authorities have been standing in the way of so-called structured dialogue. One of the largest notified bodies recently rolled out such a program, but how far it, and offerings from other bodies, can go toward providing the advice that companies desire remains to be seen.
“Why can’t the notified bodies be more like the FDA? I go to the FDA and they tell me what they want. I may not like it. I may not be happy with what they say, but I least I know what they want.”
That’s a common refrain from medtech clients seeking certifications under the Medical Device Regulation or IVD Regulation, Amie Smirthwaite, senior VP for intelligence and innovation at consulting firm RQM+, relayed during an October panel discussion at The MedTech Conference in Anaheim, CA. In her view, it’s an understandable reaction, particularly in the context of the many open questions that remain about how to properly comply with EU MDR or IVDR requirements.
| Enjoy this free article. To try out full access to Market Pathways sign up for a free trial here. |
“Manufacturers need help,” said Smirthwaite, the former global head of clinical compliance for BSI, one of the largest notified bodies. “They need input from the notified bodies” about whether their development plans, including clinical studies, are on the right track to meeting MDR expectations, she explained.
That type of input, particularly preceding formal MDR, or IVDR, submissions, is generally not forthcoming. Subsequently, sponsors have often then been surprised by the type of requests coming back from notified bodies during the official rounds of conformity assessment reviews.
“There's a regulatory plan and a clinical plan that manufacturers have for new device development and there's nobody in the EU that can sanity check that these are going to work”
“There's a regulatory plan and a clinical plan that manufacturers have for new device development and there's nobody in the EU that can sanity check that these are going to work” laments Elizabeth Gfoeller, corporate director of regulatory affairs for the Austria-based hearing implant manufacturer MED-EL, in an interview with Market Pathways. Med-EL was one of the earliest movers in seeking MDR certifications. But even with the significant homework her team did to prep for the new regulations, their inability to seek basic feedback from notified bodies about the company’s strategy complicates the path to compliance, she suggests.
“It could mean risking millions of euros on a proposal on how we want to do something with no surety that the strategy is the right one,” Gfoeller stresses. Not being able to check with the EU notified body or authority on whether, for instance, your company has selected the right classification or embarked on an appropriate clinical pathway is “hugely perplexing,” she says. In contrast, “We've got this beautiful system over in the US with the FDA, where you can go free into the Q-Sub process, and ask whatever you like and [get] a straight direct YES or NO answer.”
The reason for the lack of advice in the EU: strict rules in the regulations against notified bodies engaging in consulting for MDR/IVDR clients and worries by the bodies that over-communicating with manufacturers could put them in hot water with the EU or national government authorities.
“We are pretty terrified about making mistakes,” acknowledged Graeme Tunbridge, senior VP, global regulatory and quality, medical devices for BSI, which was one of the first notified bodies to be designated under both the MDR and IVDR. “We are rebuilding trust in the notified body system ... It’s fair to say that it’s taking a while,” Tunbridge said during the October MedTech Conference.
