Medtech expert hopeful about EU MDR/IVDR reforms

SAN DIEGO — After years of challenges and delays in implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), a top industry expert said there is hope that the European Commission will revise the regulations to ease administrative burdens following a recent public consultation.

Petra Zoellner, director of regulatory affairs at MedTech Europe, spoke about the challenges faced by the medtech industry in adopting the MDR and IVDR during a panel at the 2025 Medtech Conference. She said stakeholders should expect a plethora of updates from the European Commission next year as it works to make significant changes to the legislations. (RELATED: Medtech industry calls for major reforms to MDR and IVDR, Regulatory Focus 9 October 2025)

“The European Commission this year has gone into a remarkable improvement mindset,” said Zoellner. “This year alone, they've delivered on expanding electronic instructions for use for all professional use medical devices.”

She said the Commission has also created pathways for early coordinated procedures for clinical investigations, performance studies, and orphan devices. She also noted that Medtech Europe is advocating for a similar pathway for certain IVDs.

“The Commission's really getting into improving our system,” said Zoellner. “In just two months, they will publish a revision proposal, which will reform the [regulations].

“This will be a broad and deep reform, according to the European Commission,” she added. “It's going to cover a number of different areas, all designed around their agenda to provide simplification of the regulations to reduce administrative burden, and also to shore up and support the competitiveness of our industry, especially the wider sector, including [small and medium-sized enterprises (SME)].”

While Zoellner hasn’t seen the proposed texts, she said they are expected to be a fundamental reform.

“I've heard that they will be removing some reporting obligations, duplications and regulatory requirements, also providing more digital tools into the regulations, improved scientific and regulatory coordination, and also some recognition of [Medical Device Single Audit Program (MDSAP)] for [Quality Management System (QMS)] certification,” said Zoellner. “A number of areas will be touched, and this is a very small list that I've just mentioned.

“This means that the European Union is about to go into a major political reform, and with that will come opportunities, as well as risks for our legal framework,” she added. “Even though it's a simplification, there will be political discussions where they can amend anything in the proposal coming from the European Commission.”

Zoellner said the revision discussion is optimistically expected to take 18 months but may take up to three years or more. In the meantime, and in parallel, she said the Commission is expected to publish a couple of implementing acts by early 2026. She said they are expected to expand the definition of well-established technologies and the categories that apply to them.

According to Zoellner, the Commission is expected to require a limit on the amount of time that a notified body takes to review certification processes and may also limit the time to review pre-approvals and recertification. She also said it plans to launch a pilot program to test a pathway for breakthrough innovation before the end of the year.

“Expect many more improvements to come in the next two to four months,” Zoellner added.

An audience member noted that the industry has struggled to keep up with interpretations, guidances, and best practices from MDR and IVDR and questioned whether the expected reforms will make life easier or add to the challenges.

Zoellner said she doesn’t know if the reforms will make life easier because she hasn’t seen the proposed changes yet, but she noted that Medtech Europe has been advocating for improvements to reduce administrative burdens. For example, she said they have advocated against requiring annual safety update reports where there are no fundamental changes to report to reduce paperwork.

“I think with the MDR and the IVDR, the legal text wasn't necessarily that burdensome,” said Zoellner. “It's the way it's been implemented, which is quite a lot above and beyond what was maybe intended by the legal text.

“I think we not only need to reform the rules to make them less duplicative, less burdensome, more predictable, but we also need to work on the implementation side and the government side,” she added.

Zoellner echoed other panelists who said the EU's product regulation culture needs to change. She also said the industry needs to have conversations with the Commission to reform the governance structure and make it more business-friendly. For example, she said that guidance documents may be written, redrafted, and/or combined to be easier to read, especially for SMEs.

"We don't necessarily need to have over 100 guidance documents. We could also maybe have 10," said Zoellner. "There are not that many procedures in the MDR and the IVDR... Maybe we could combine some of them and make them a lot more searchable, maybe digital, maybe with different chapters, so that... you can go to the right chapter and find how to follow the MDR requirements or the IVDR requirements, as opposed to having to kind of digest all of the guidance documents and then find your way through a maze."

Medtech expert hopeful about EU MDR/IVDR reforms

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