Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition

AMSTERDAM – Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD experts.

As guidances for the IVDR and Medical Device Regulation (MDR) have trickled out, some experts said they are concerned that the guidances always contain the recommendations they presumed would be made.

A panel of notified body experts discussed the European Commission’s Medical Device Coordination Group (MDCG) 2022-14 position paper at RAPS Euro Convergence 2023 on 12 May. The paper was released last year to help alleviate notified body capacity concerns amid the MDR and IVDR rollouts.

On the panel were Andreas Stange, senior vice president at TÜV SÜD Japan; Marta Carnielli, head of IVD certification TÜV SÜD Germany; Elizabeth Harrison, global head for IVD medical devices at BSI Group; Liz Gommans, technical and RA specialist at DEKRA Certification B.V.; and Tom Patten, certification and inspection officer for IVDs at the National Standards Authority or Ireland (NSAI). The session was moderated by Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD GmbH, and Anja Wiersma, CEO of mi-CE consultancy.

During the discussion about how MDCG 2022-14 affects the transition to IVDR from the previous directive, one attendee said the position paper primarily addressed issues with MDR and asked what needs to be done to address issues related to IVDR. (RELATED: Experts: MDR transition delay needs clarification, industry engagement to succeed, Regulatory Focus 10 January 2023)

“I think we need IVD specific guidance as much as possible written by knowledgeable IVD people because the speed with which a notified body can complete the technical documentation review if it's high quality is actually quite fast,” said Harrison. “We've finished reviews start to finish in than less than three months, if it's high quality and we have virtually no questions.”

In an earlier panel at the conference, one attendee raised concerns about the ever-changing guidance landscape as firms transition to the regulations. Experts acknowledged the difficulty of dealing with uncertainty until guidance is issued but noted that sort of ambiguity is expected among early adopters. They urged companies to not be discouraged and to continue certifying their products as soon as possible to get ahead of impending deadlines. (RELATED: Euro Convergence: Experts discuss MDR's early adopter pains, Regulatory Focus 11 May 2023)

While a notified body’s review of an IVDs can take 12 to 18 months, on average, Harrison noted that that doesn’t take into account the time that manufacturers take to answer questions from notified bodies, which she said is the most significant part of that review timeline. If the submission quality is high, manufacturers can get their product through the review process more quickly.

“We need more guidance and IVD-specific guidance as soon as possible,” said Harrison.

Patten agreed with Harrison and reminded the audience that MDCG 2022-14 is a position paper and not a guidance document. He said it is useful but at this point stakeholders need guidance documents to help them understand what regulators expect of them.

"What we really actually need is structure related to examples for the codes and what experience is actually relevant for each code. That would help us so much,” said Patten. “Everything kind of follows from that, because then that allows us to train staff more quickly, we can identify the right resources more quickly and we can then be effective more quickly."

Harrison added that while she welcomes the publication of any guidance document, they are typically written from the MDR perspective and it takes some effort to translate that for IVDR. She notes one such area has been interpreting the use of structured dialogue between notified bodies and manufacturers which is especially difficult for manufacturers who have not gone through the process before.

"You probably didn't know that you could ask us questions,” said Harrison. “Sure, we can't consult, but we're very practiced in stopping talking when we know we're crossing that line.”

She urged manufacturers to do their homework first by watching webinars and reading guidances and joint statements, and then come to the notified bodies with specific questions rather than basic ones so they don’t waste their time.

The panelists repeatedly noted that notified bodies have ramped up capacity to handle new applications but they’ve noticed that after an initial deluge of applications in 2021, the number of applications have dropped as deadlines have been extended.

Gommans said that manufacturers need to avoid a bottleneck when the IVDR deadline approaches. If notified bodies are overwhelmed by manufacturers submitting applications at the same time, experts have warned it may lead to significant delays and withdrawal of products from the European market.

"I know it has been said a thousand times already, but please submit the files. We have expanded our team, especially for IVDs, and we do have capacity at the moment,” said Gommans. “If you wait another year and a half it will probably be a different story and we will be completely packed.”

Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition

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