Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR

TORONTO – As medtech companies work to comply with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), stakeholders disagree on whether legislative action is needed to revise the regulations to prevent products from leaving the EU market.

A 16 October panel at the 2024 Medtech Conference included experts who discussed the progress made in transitioning to MDR and IVDR from the previous directives. They agreed that the medtech industry is struggling to comply with the new regulations, and some advocated for new legislation to prevent products from leaving the EU market. Such concerns have already led EU authorities to extend the transition periods for both regulations.

The panel took place a day after Medtech Europe sent a letter to Stella Kyriakides, European health and food safety commissioner, asking her to take several steps, including implementing legislative reforms for MDR and IVDR. The industry group also asked for bridging measures to prevent products from leaving the EU market until such reforms are enacted.

Petra Zoellner, director for regulatory affairs at MedTech Europe, said that the European Commission is conducting a targeted evaluation of MDR and IVDR and how the regulations have been adopted. She said the Commission is expected to present a legislative package of reforms based on the evaluation to improve the regulations, but that could take years to implement. She said stakeholders want to see changes and more predictability and efficiency in the timelines sooner.

"Yeah, let's do the targeted evaluation. Yes, let's have a proper discussion, let's come to a correct and full-quality package, but there are some urgent problems that need to be tackled now," said Zoellner.

Michel Marboeuf, senior director for regulatory affairs at Stryker, said a big challenge his company has faced over the past few years is that legacy devices and new devices go through the same pathway to get to market despite the fact there is significantly more experience with legacy devices. He noted that legacy devices are not given priority which has led to significant lead times to get recertified and additional costs to keep the product on the market.

“The situation is improving because we are now at the top of the learning curve, or at least I hope so,” said Marboeuf. He added that a big takeaway is that the company has become better at communicating with notified bodies (NB) and sharing their regulatory plans for products they plan to bring to market, which can help the notified bodies manage the workload.

Despite the progress, Marboeuf is concerned that there are more than a hundred Medical Device Working Group (MDCG) guidances that are not binding but have created more hurdles for companies trying to comply with the new regulations. He said they would like to see legislative changes to reform the system.

“We are expecting legislative measures to move to a much more lean, efficient pathway to keep our existing products on the market for patients and to support innovation,” said Marboeuf. “Innovation is leaving Europe because of this pathway.”

He lamented that even products that are not highly complex are getting to market in the US four years ahead of Europe because sponsors are required to collect clinical data to pass conformity assessments.

Graeme Tunbridge, a senior vice president at BSI, pointed out that even though the regulations were passed in 2017, it took two years for NBs to be designated. After that, he said they got busy working on renewals which weren’t completed until mid-2022.

It wasn't until 2022 that Tunbridge argued that their workload shifted so they could act as a regulation-implementing notified body where they could focus on existing clients transitioning from the MDD to the MDR and turned away new clients because it was too risky.

Tunbridge said that about six months ago, BSI started publishing its lead time so that companies could be more predictably informed about the timelines their products could undergo for audits and technical documentation reviews.

“There are still some pinch points, but we are definitely seeing improvements,” said Tunbridge. “I would like to give us a chance and I’m going to respectfully disagree with the need for urgent action.”

“I think there are lots of things that can and should be done, but we also need to work from a place of stability,” he added.

Christina Ziegenberg, deputy managing director and head of regulatory affairs at BVMed, argued that if an inefficient regulation is implemented that has structural problems, the system will adapt, but the cost may be too high. She repeated that Europe is losing products, manufacturers, and companies are closing, especially small- and medium-sized enterprises, and patients are not getting treatments.

“There has to be structural change, and it has to be now because if we wait, more products and more manufacturers will go away,” said Ziegenberg.

Tunbridge argued that the problem has been implementing the existing legislation, including policy decisions that have had huge ramifications for transitioning legacy devices. He agreed a major problem has been the number of guidances that have been issued and argued that before new guidances are introduced some of the ones already in the books may need to be withdrawn. Ultimately, he said changes can be implemented without creating more legislation, which could create more bureaucracy and problems reinterpreting how to transition products.

“Let’s get some real work done on how the implementation has been problematic, and we can roll back on some of that,” said Tunbridge. “Implementation has been the real problem, and there’s nothing stopping us from peeling some of that back.”

Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR

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