Stakeholders seek short-term fixes, long-term reform for European medtech regulations

ANAHEIM, CA – Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.

Cracks in the current system have become more apparent as manufacturers work to transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), Petra Zoellner, director for IVDR and MDR at MedTech Europe, told attendees at the 2023 MedTech Conference.

“We shouldn’t light a match and set fire to the two regulations, but I do think we need reform,” she said.

Zoellner said the medtech lobby group MedTech Europe has asked the European Commission for comprehensive reform of the two regulations and wants to start a dialogue on what those reforms should look like. She argued there needs to be reforms to the broader system to improve efficiency and develop more agile pathways. The medtech industry is also seeking a single accountable structure that ensures efficiency and consistency and promotes innovation, she added.

Currently, medtech regulations are implemented through a complex system that includes laws developed by the European Union and regulations implemented by the European Commission, which are ultimately interpreted on the national level by local authorities.

“The minimum time frame that you could actually see a reform of the system would probably be about three years, but we would need to start discussions today in order to gather around the table and to get agreement on the issues,” Zoellner said. “Obviously we can't wait around for three years to fix some of the ongoing challenges in our system.”

“We need to put in place solutions for whatever we can solve now with the current framework,” she added.

Presuming that all stakeholders agree on the need for reform, Zoeller estimates that it will take a minimum of three years to reform the system. She noted that there is a political turnover at the European Commission every five years, which is set to happen next year.

The medtech industry and notified bodies already have a list of ideas on how to improve the system but they need the regulators to sit at the table with them to hash things out, she said.

In the meantime, Zoeller said it would be helpful if regulators could provide longer timeframes to transition to the MDR and IVDR, clarity on how long it will take to get certificates based on notified body best practices, and more information on the costs of transitioning products. Zoeller also called for a more pragmatic approach to how many products need to be sampled under the quality management system (eQMS) and to post-market requirements, as well as new pathways for orphan products.

She also noted that there are still many questions about the European database on medical devices (EUDAMED) as well as potential ways to improve it.

“There’s a lot of scope for fixes, for solutions, for ways to make the system more efficient and better fit for purpose,” Zoeller said. “But [we need to] do what we can do now.”

Zoeller also called for greater harmonization between the various member states on how to implement the regulations and noted that there are about 80 guidances already in place that are detailed but not always helpful.

While there needs to be alignment in the guidances on what the focus should be in terms of safety and effectiveness, they often act as “straitjackets” for notified bodies that prevent them from exercising flexibility, she said.

Stakeholders seek short-term fixes, long-term reform for European medtech regulations

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