Despite geopolitical pressures including war in Ukraine and supply chain bottlenecks due to Iran’s closure of the Strait of Hormuz, innovation is continuing at pace in Europe’s medical device and in vitro diagnostics (IVD) industry.
At the MedTech Forum, held in Stockholm Sweden between 11-13 May, industry thought leaders from across Europe convened to reflect on the significant innovation drives being seen in Europe’s medtech industry.
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A key recent adaption in Europe is an innovative device pathway pilot programme that is being spearheaded by the European Medicines Agency (EMA).
Launched on 26 April, the purpose of the pilot is to test a new regulatory pathway aimed at supporting patient access to innovative medical technologies.
Opening Day 1 of the MedTech Forum, MedTech Europe CEO Oliver Bisazza praised the EMA-led innovation pilot, deeming it to be “exactly what our industry has been calling for” and a necessary step to “keep bringing innovation to Europe”.
Weighing the benefits of the EMA’s pathway
The first consideration by the EMA for companies that want to volunteer their devices for evaluation under the new pilot pathway is to determine whether the device is novel and meets an unmet need, said Flora Giorgio, head of unit at the European Commission (EC).
“With these factors determined, we ask the Notified Bodies to prioritise those technologies in their certification process, but also to provide in the current framework all the possible support to actually speed up and support those devices to activation,” Giorgio explained.
Giorgio shares that the EC/EMA did not want to use the same breakthrough pathway as seen at the US Food and Drug Administration (FDA) or other global regulators, instead deciding to run the open-ended pilot on a voluntary basis to inform the development of its own innovation pathway.
“We then want to re-target the needs of the sector through follow-up legislation, which will codify the learning of the pilot,” Giorgio added.
Class III and implantable devices are the current categories available for the pilot, with 22 May the cutoff date for companies who wished to apply such devices for it.
Welcoming the pilot, Rita Peeters, senior director, regulatory affairs, EMEA at Johnson and Johnson (J&J) MedTech, shared that the company has been working with manufacturers to determine what a breakthrough pathway could look like in Europe.
“Our conclusions are that it is going be particularly important to have structured dialogue with the Notified Bodies early enough, even before meeting the pilot’s designation, to know what needs to be done to meet it, and how the pilot will interrelate with dictates set out under the European Union’s medical device regulation (EU MDR),” Peeters said.
It is important to note that the EMA plans to evolve the guidance for industry regarding its pilot as times goes on, with no end date currently set for the initiative. Peeters wondered if there could be the possibility of reliance to support the assessment of breakthrough or orphan devices in Europe.
“If there is an approval for a device outside of Europe, how can we bring this into Europe? We have to have reliance, and then for European competitiveness, perhaps we can look at the possibility of targeted incentives that can be given to early developers,” Peeters said.
“For instance, on clinical data protection exclusivity for perhaps 10 years, with a view to moving that innovation back to Europe.”
Regarding the EMA’s pilot, Pascal Waucquez, head of the EMEA region at French biotech bioMérieux, expressed his hope that it would in time lead to a comparable mechanism for faster regulatory approval for IVDs in Europe, too.
However, Waucquez stated that regulation alone is not enough. For IVDs, rationalising adequate funding paradigms in Europe is going to be equally critical moving forward – a matter he hopes may be a hurdle given the attention it deserves moving forward.
Waucquez explained: “When it comes to IVDs, the current model used for their valuation is based on the pharma model, and it just isn’t appropriate because it doesn’t capture the full benefit and value of diagnostics.”
The state of the EU IVDR
No European medtech conference would be complete without a discussion of the long-gestating in vitro diagnostic (IVDR) and MDR regulation.
It has been acknowledged by market participants that recurrent delays to this regulation, which was introduced in 2017 and initially mooted for full implementation by 2022, is having a drag on innovation, particularly within Europe’s IVD space.
Speaking on a separate panel on the latest thinking around the regulation, Flora Giorgio explained that the transitional provision was extended to ensure that healthcare professionals and patients in Europe could continue to have access to devices.
“We closely monitoring that there is device transition, but not only that, we are also stabilising the system,” Giorgio explained.
Providing the perspective of a Member State, Lena Björk, head of the medical device division at Sweden’s medical product agency, emphasised that “we are in a crucial phase” regarding the opportunity to revise the MDR/IVDR for market participants.
“We all need to work together towards a predictable and sustainable regulatory framework over time, ensuring that it is also sustainable for all parties, including manufacturers, Notified Bodies, and healthcare patients,” Björk said.
“If these factors are not managed, the system will not work, and the biggest risk then would be that we lose the credibility of the EU CE mark.”
In an interview with Medical Device Network during the MedTech Forum, MedTech Europe weighed in on the current state of the IVDR’s rollout.
While there remain significant investment and presence of companies in Europe in the IVD space, “about a third” of the larger companies are saying that they prefer to place their first launch products and improvements elsewhere in the world than Europe first, said Petra Zoellner, director of regulatory affairs (IVDR & MDR) at MedTech Europe.
“This is a significant departure from how things looked about nine years ago, before the IVD regulation,” Zoellner continued. “Europe was the place of first launch across the board, but now we’re getting products later, with European patients and labs getting products later, too, or not at all, compared to other jurisdictions.”
Outlining that MedTech Europe would “obviously like to see this trend reversed”, Zoellner expressed the trade association’s view that there needs to be a “rebalancing” of the current regulation.
“This rebalancing would make [the IVDR guidelines] them more innovation friendly and efficient, less complex, get the regulation right in terms of safety and performance, and make sure that everyone, no matter what the size of company, can participate,” Zoellner said.
Zoellner went on to highlight several updates to the IVDR regulation that she described as “steps in the right direction”. These include the EC’s recently updated rules to the MDR/IVDR that add timelines for Notified Bodies, outlining the maximum timelines for product and quality management system (QMS) certification, as well as recertification. These rules will apply from 25 February 2027.
Zoellner concluded: “Once that’s implemented, it should add considerable predictability to the system, because then market participants are going to have a clearer picture of how long it will take, and how long they will have to invest, before obtaining their certificate [under the MDR/IVDR].”
