Industry wants more streamlining following recent EU reforms

BRUSSELS – While the European Union is undergoing major reforms to its regulation of medical devices, diagnostics, and drugs, an industry representative said there are still challenges and that more actions to streamline regulations and reduce the burden on industry are needed.

During the plenary session at the DIA-RAPS Combination Products in the EU conference, a panel representing the healthcare product industry, notified bodies, and regulators discussed upcoming legislative reforms, such as the EU General Pharmaceutical Legislation (GPL), the Biotech Act, and the planned revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Representatives from the European Commission and the European Medicines Agency (EMA) acknowledged the challenges that the medical industry has faced in the EU and said they are working to expedite the adoption of legislation that could ease regulatory burdens.

Regulator perspective

Thomas Wejs Møller, a panel co-moderator and senior director for device global regulatory affairs at Novo Nordisk, said that Europe is facing numerous challenges and needs to ensure it is ready for whatever the future brings. He discussed how other regulatory regimes oversee products and noted that dealing with the US Food and Drug Administration (FDA) is more straightforward because it's a single agency, whereas in the EU, companies must navigate 27 countries and more than 50 notified bodies.

Flora Giorgio, the head of the medical devices unit at Directorate-General for Health & Food Safety (DG SANTE) at the European Commission, said that Europe is often accused of being slow and not agile or innovative enough. However, she argued that the federation is an innovative 56-year experiment, given the cultures, rules, languages, and monetary policies that encompass it.

"Europe has delivered a lot, and it's not a coincidence that Europe is the place that most citizens want to live, it's where everybody wants to come," said Giorgio. "Europe provides you safety, provides you a safety net, doesn't let others behind and there's a core set of values and rules ... maybe too many."

Giorgio said that they need to accept that Europe has a different system of governance and work within its framework. She also noted that they have taken steps to centralize their regulatory regime within the proposed new legislations and there were discussions whether they should be more like FDA.

"Should we have changed fully, should we have gone the FDA model," said Giorgio. "There was a lot of reflection, a lot of debate, a lot of input received, [but] nobody seemed to be really keen in going that way."

Ultimately, Giorgio said that the proposed MDR and IVDR reforms are intended to simplify regulations, increase competitiveness, foster a more innovation-friendly ecosystem, and accelerate digitalization.

Alberto Gañan Jimenez, head of committees and quality assurance at the European Medicines Agency (EMA), said that the next three years are going to be very challenging for the agency as it works to implement the provisions of the proposed legislations in partnership with the European Commission and the European medicines regulatory network. He said the first challenge will be implementing the new GPL.

"It is the most significant overhaul of the pharmaceutical regulatory framework in the last two decades," said Jimenez.

"It's a once-in-a-generation opportunity to reset how the medicines framework will be for the next decades.

He said it will have a huge impact on EMA because of its unprecedented scale and interconnectivity with different provisions and regulatory areas and will require a huge guidance-making effort in a compressed timeline.

"It will have a huge impact on the way that the agency is organized, mainly in its committees," Jimenez added.

Streamlining regulations

Amanda Matthews, head of regulatory affairs for combination products and medical devices at Pfizer UK, said there is more that could be done to reduce regulatory burdens for medical manufacturers. On a positive note, she said the industry welcomed the harmonized definitions adopted by the proposed legislations and aligned with global market requirements. She emphasized that the proposed legislations should be developed to work well with each other, especially as technological advancements blur the lines between drugs, devices, and diagnostics.

"The inclusion, from our perspective, of clear definitions in the upcoming legislations we hope will help continue to address some of the ambiguities that have historically complicated development in [the combination product] space and enable us more efficiently to bring products through development," said Matthews. "We also hope that it brings new guidance, as well as refinement on processes that have very historically been solely for medicines.

"Industry certainly welcomes these steps that we see, and we see that they're starting to lay the groundwork for more predictable and efficient regulatory pathways in the future," she added.

Matthews praised other steps regulators and legislators are considering but said that industry thinks more can and should be done to ease regulatory burdens and improve efficiency, such as adopting a single unified system. Ultimately, she said industry is advocating for better collaborations and frameworks that work well together, but that means regulators need to make further improvements and eliminate redundancies.

"As technology advances, we need a regulatory framework that facilitates rather than hinders innovation," said Matthews. "It's great to see some of the progress already with regards to COMBINE and the legislation reform, etc., but it's not really where we can stop."

For example, Matthews noted that the proposal to reform MDR didn't address Article 117 of the MDR, which mandates that the device component of drug-device combination products be assessed by a notified body to ensure compliance with the General Safety and Performance Requirements (GSPR).

"Given that Article 117 actually modifies the medicines directive, is this now time to have it removed, given what we know is coming within the GPL," said Matthews. "In doing so, from an industry perspective, we view it can actually remove some of that ambiguity with regards to the broader applicability of the MDR to these products, which is something that again, time and time comes up.

"We believe we should be looking at continued refinement of the processes and guidances to lessen this regulatory burden for us," she added.

2026 Combination Products in the EU

Industry wants more streamlining following recent EU reforms

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