
What happened?
On 28 January 2025, Friends of Europe convened a multidisciplinary and multistakeholder group to discuss strategies for streamlining regulatory frameworks in the life sciences sector in order to enhance innovation and competitiveness.
Europe’s medical technology sector faces a critical juncture due to complex, costly and inconsistently applied regulationsthat have slowed the market entry of new products. It was noted that stakeholders are grappling with how to maintain the EU’s innovative edge whilst ensuring patient safety and access.
There was consensus that the current medical devices regulation is seen as overly burdensome, hindering innovation and leading to critical devices being taken off the market, particularly in areas like paediatric cardiology and neurology, affecting large swathes of communities across the demographic divide. The moderator summed up the mood: “We’re at a point where the messages we’re receiving from healthcare professionals, hospitals and industry is that the system is blocked”, underscoring the dire need for an overhaul of the EU’s medical devices regulation.
Europe is still recognised as having strong assets in regard to medical research and innovation technology, but struggles to effectively translate this into successful commercialisation and market access for new devices. There have been longstanding calls to simplify regulations, reduce red tape and create faster pathways for truly innovative medical technologies. Central to the discussion was the need to bring patients, advocates, clinicians and providers together to
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Schedule
- How can Europe streamline regulatory frameworks in the life sciences sector to enhance innovation and competitiveness while ensuring safety and quality?
- What strategies should be implemented to strengthen Europe’s self-sufficiency in critical sectors, including MedTech, to reduce dependency on non-EU sources?
Moderator
Tamsin Rose
Facilitator
Speakers

President-elect of the European Society of Cardiology
Cecilia Linde is a Professor in Cardiology at Karolinska University Hospital and the Karolinska Institutet in Stockholm, Sweden. She was previously Head of Cardiology at the Karolinska University Hospital. Her research focuses on devices such as cardiac resynchronisation therapy (CRT) and epidemiology in heart failure. She was the principal or co-principal investigator of international randomised controlled studies on cardiac resynchronisation therapy CRT for heart failure such as the MUSTIC, REVERSE, MIRACLE-EF and in cardiac contractility modulation trials such as the CCM HFpEF study. She has previously been the director of the Swedish Pacemaker and ICD registry. She is currently the President-elect of the European Society of Cardiology (ESC) 2024-2026 with special focus on advocacy. Professor Linde contributed to many guidelines of European Heart Rhythm Association and Heart Failure Association. She has authored over 300 papers, reviews and editorials covering a wide variety of topics and is the executive editor for the topic heart failure of European Heart Journal.

Head of Unit for the Health Division at the Permanent Representation of the Federal Republic of Germany to the European Union
Sabine Kossebau, together with her team, represents Germany in the relevant Health Working Parties in the Council of the European Union, and towards the other European institutions and stakeholders in Brussels. She has an extensive background in health policy and regulatory matters, having worked on a multitude of national and European legislative procedures and health policy matters in the Federal Ministry of health and during a previous secondment to Brussels. Her health-related work experience includes being the personal advisor to the State Secretary, head of unit for cabinet, parliamentary affairs and federal state relationships, and working as a legal advisor in various units in the ministry.

Hungarian Member of the European Parliament and 2025 European Young Leader (EYL40)
András Tivadar Kulja is a surgeon and digital-health expert who was elected to the European Parliament in June 2024 on the ticket of Hungary’s opposition Tisza Party. With 360,000 followers on TikTok, he has Hungary’s most widely-viewed health-education channel. Kulja used his high social media profile to counter disinformation during the COVID-19 pandemic. Inspired to enter politics after attending an opposition rally in April 2024, Kulja gave up his hospital posts to speak freely about Hungary’s healthcare problems. He is a Vice-Chair of the European Parliament Committee on the Environment, Climate, and Food Safety and a member of the Committee on Public Health, where he advocates for a stronger EU role in promoting healthcare reform.

Facilitator
Tamsin Rose is a facilitator who was until recently a senior fellow for health at Friends of Europe. Having studied international relations, she has 25 years of experience working across the European continent from Ireland to Mongolia. A natural communicator, Tamsin has been a radio reporter, worked on press for the EU Delegation in Moscow and is currently a member of the external speaker team for the European Commission Directorate-General for Communication, describing how the EU works and key policies to visitor groups from around the world. Since 2002, she has specialised in public health and public participation issues, serving as the Secretary General of the European Public Health Alliance (EPHA), and providing strategic advice for health groups on how to engage successfully with the EU.

Executive Vice President and Chief ESG & Legal Officer at Royal Philips
Marnix van Ginneken is the Executive Vice President and Chief ESG & Legal Officer of Royal Philips. He is responsible for driving environmental, social and governance efforts across the company, including sustainability, and is also responsible for legal, intellectual property & standards, and government & public affairs. Marnix is also a member of the Board of Management and the Executive Committee, as well as Chair of the Board of the Philips Foundation. Before joining Philips, Marnix worked for Akzo Nobel, and as an attorney in a private practice. In addition to his role at Royal Philips, he has been a Professor of International Corporate Governance at the Erasmus School of Law in Rotterdam.

Deputy Head of Unit for Health Innovations & Ecosystems at the European Commission Directorate-General for Research and Innovation (DG RTD)
Arjon van Hengel works for the European Commission where he is currently the deputy Head of Unit in the Health Innovations & Ecosystems Unit within DG RTD. His work within this unit aims to foster the development and uptake of breakthrough innovations in the field of health and care, and to help citizens stay healthy. Van Hengel was team leader for infectious diseases during the first one and a half year of the COVID-19 pandemic, policy officer for antimicrobial resistance research and has led a research group that develops and validates analytical detection methods for food allergies. Prior to joining the European Commission, he was a research scientist at the John Innes Centre in the UK.
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