Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.
Amanda Maxwell, European Regulatory Affairs Editor, Medtech Insight
“Right now, we need a simplification of regulatory schemes and more focus on global harmonization,” Erik Raadsheer, senior director at Align Technology, told the opening plenary session at the RAPS 2020 Convergence on 25 October.
There is an increasing trend for markets that have been aligned with the EU’s medtech regulations to take measures that will lead them to diverge, with the UK, Switzerland and Turkey all looking at going their own way, Raadsheer, regulatory and government affairs and quality assurance director EMEA, said at the meeting.
Political shifts were another concern. The European Commission’s Erik Hansson listed increasing trade protectionism as potentially creating obstacles to more globally harmonized device regulations.
“We can see in some countries around the world that are important in terms of medical device trade that protectionist opinions are becoming increasingly vocal,” Hansson, deputy head of the commission’s medical devices unit, said.
Raadsheer added: “We are in an era now where we need to challenge whether such national divergences will contribute to device safety, or whether they are purely politically driven. “What is certain is that they bring more complexity and more costs, ultimately limiting what is available for patients, the Align Technology director asserted.
Increased workload translates into an increased demand for resources, including medtech experts to carry out that work. But as everyone is “fishing from the same pond,” he warned, and the lack of available qualified people could result in product delays.
Not only should industry be worrying about growing regulatory fragmentation, but also about the fragmentation that already exists within the EU regulatory system itself, Eric Klasen, regulatory affairs, quality and life sciences at Waypoint Consulting, said.
Given how the governance of pharma, biotech, in vitro diagnostics and medtech are all siloed, he questioned whether the current European health care product governance structure is fit for the future, given the “explosion” of innovative products that cannot simply be regulated by a single scheme. He cited innovation in the area of drug/device combinations, artificial intelligence, and software as a medical device as examples.
He called for dialog at EU level to address this.
“We need to have better collaboration between the various EU regulatory schemes;” he said, noting that growing numbers of medical technologies coming up cross over into other product areas.
For medical device regulatory oversight alone, there are multiple notified bodies, but they are all working on their own. And there are multiple competent authorities, but they have their own territorial country-specific responsibilities. And the European Medicines Agency (EMA) plays yet another role, he said.
“The best thing would now be if we could get a consolidated, holistic view on how governance should operate for all these new technologies that are coming at us,” he suggested.
