A group of the world’s leading experts in the treatment of stroke are calling on the EU to make sweeping changes to regulations governing the development of medical devices, adding that the current rules are inhibiting innovation and preventing patients from accessing life-saving care.
A panel of clinicians, consultants, innovators, and company executives involved in the development of specialist medical devices made the call during the inaugural Croatian Meeting for Neurointerventional Development — or CRONOS conference — in Sibenik, Croatia, earlier this month.
Neurological disease and stroke are the second largest contributors to death in Europe. However, the group said that higher costs associated with the unpredictable and lengthy process by which new devices are certified under the EU Medical Device Regulation (MDR) are preventing companies from bringing innovative technologies for the treatment of stroke to the European market.
As many companies involved in the innovation of neuro-intervention technology are SMEs, critics say that the costly regulatory landscape in Europe is forcing companies to follow the demands of venture capital investors to seek approvals in other markets, including the United States and Japan.
In response, the CRONOS panel urged European lawmakers to simplify the approvals process by adopting a “fast-track” pathway for innovative technologies, one like the breakthrough device designation process used by the US FDA.
The pathway could involve the introduction of a pre-submission process to enable independent regulatory bodies the opportunity the review the clinical strategy while it is ongoing. A system of conditional approvals could also be introduced based on data from 20% of patients enrolled in a clinical trial, with the remaining 80% to be analysed in post-market clinical follow-up.
Other reforms proposed during the CRONOS conference on May 1 include:
• Applying Article 82 governing the academic and clinical research for Early Feasibility Studies to European SMEs
• Introducing Key Performance Indicators (KPIs) for notified bodies and the open publication of the KPI performance for each notified body related to the review and approval of fast-track submissions
• Implementing a Central Oversight Agency (COA) to ensure consistency, pragmatism, and harmonised implementation of the requirements protecting the EU Healthcare System
Among the expert panel at the CRONOS conference were Prof Jens Fiehler, the former president of the European Society for Minimally Invasive Neurological Therapy (ESMINT); Dr Carlos Pena, former Director of the US Food and Drug Administration’s Neurology Department; Dr Bassil Akra, CEO of the Germany-based consultancy company AKRA Team; and Dr Vladimir Kalousek, radiology specialist and member of the European Committee for Neuro-interventions (EBNI).
Speaking after the event, Dr Bassil Akra said that the group’s proposed reforms will now be presented to the European Commission.
Dr Akra said: “There is a distinct lack of transparency around the expectations of the various notified bodies and designating authorities, and there are no metrics by which they can be held accountable. The lack of consistency and predictability across these regulatory responsible parties has serious implications for SMEs in terms of costs, timelines, and resources. This increased regulatory burden is turning off venture capital investors who are in turn pushing SMEs to the US and other markets. Those technologies that do get approval come to market at a much higher cost to the healthcare system overall.
“The group brainstormed some solutions to these problems, with a focus on increasing transparency and predictability among regulatory institutions and their processes, and the overall attractiveness of the European market. These measures will now be submitted to the European Commission where we hope they will be implemented quickly to get innovation back on track in the EU. Notified bodies need to be empowered to support pragmatic and patient-oriented certification approaches in the EU.”
Prof Jens Fiehler believes the MDR will prevent novel technologies being available to patients in Europe.
Prof Fiehler said: “Neurological disease and stroke are the second biggest contributor to death in Europe. The treatment of these diseases continues to be positively impacted by the development of novel technologies which improve outcomes and reduce complications. However, as clinicians, we are already seeing instances where new technology will not be available in the EU for the foreseeable future. That’s largely down to the challenges surrounding the new MDR.”
Dr Carlos Pena hailed the US FDA’s approvals process in contrast to the MDR, saying that its predictability is the key factor in its success.
Dr Pena said: “The US approval process is well defined, understood and supported by the government. The FDA has done a great job in the last 10 years to improve the submission process to enable innovation in a timely manner. The predictability of the US FDA regulation, and the collaborative approach taken by the agency is much easier to navigate, budget for, and ultimately succeed.”
Dr Vladimir Kalousek said: “It was an honour to bring this panel of experts to Croatia, and to enable such wonderful discussion and alignment. We would encourage other EU clinical and industry communities to come together to discuss their challenges and open dialogue with the regulators so the EU can continue to be at the forefront of medical innovation.”
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About CRONOS:
The Croatian Meeting for Neurointerventional Development in Sibenik (CRONOS) was held for the first time in May 2024 with the aim of bringing together clinicians & innovative industry partners to discuss challenges and strategies to improve accessibility to novel devices being developed to treat stroke and other neurological diseases.
Attendees included:
Prof Jens Fiehler, University of Hamburg Eppendorf
Prof Adnan Siddiqui, UBNS & Jacobs Institute
Prof Tommy Andersson, Karolinksa University Hospital, Stockholm & Ceroflo
Dr Vladimir Kalousek, KBC Sestre Milosrdnice Zagreb
Dr Carlos Pena, Jacob’s Institute
Dr Bassil Akra, AKRA Team GmbH
Chloe Brown, Ceroflo
Franz Bozsak, Sensome
Michael Karim, Oxford Endovascular
Alina Latus, Sensome
Katia Mandaltsi, Oxford Heartbeat
Katerina Spranger, Oxford Heartbeat
Christophe Chautems, Nanoflex Robotics
Kanae Doda, TG Medical
Marc Paris, 3comma Medical
Amir Arthur, Luseed Vascular
