Following a record-breaking congress in Munich, the ESC is putting science at the heart of the conversation
By bringing together experts from around the world, ESC Congress provides an unparalleled opportunity to share the latest in life-saving science and to collaborate with national cardiac societies and ESC committees.
This year's Congress featured 1,750 sessions and explored the role of artificial intelligence (AI) in cardiology. The potential benefits of AI tools, and how to ensure their safe and responsible use, look set to remain a hot topic. Indeed, the subject features in this month's interview, which focuses on the ESC's ongoing efforts to inform EU regulations in digital health, medicines, medical devices and tobacco control.
As the ESC looks to the future under the leadership of President Cecilia Linde, ESC Congress 2026 inspired our community to bring cardiovascular science to our policy work and, most importantly, to patients.
Advancing the ESC's Regulatory Affairs priorities
"This is an exciting time for innovation in cardiovascular health," says Prof. Paulus Kirchhof, Chair of the ESC Regulatory Affairs Committee. "With new medicines and devices, alongside advances in digital health, there are opportunities to move the needle."
The Regulatory Affairs Committee is actively engaged in four key areas shaping the future of cardiovascular health: medicines, devices, digital health and nicotine.
Prof. Paulus Kirchhof
1. Contributing to the evolution of medicines regulation and evidence generation
Following intensive consultations and negotiations, an overhaul of EU pharmaceutical legislation was agreed in late 2025. Attention now turns to implementation and the development of influential guidance documents. The ESC stands ready to contribute scientific and clinical expertise to support this process, bringing the perspective of the cardiovascular community.
The ESC continues to engage with regulators and policymakers on evolving approaches to clinical research, medicines assessment and post-authorisation monitoring. This includes the use of observational data, registries and national datasets to strengthen evidence generation and support the safety monitoring of innovative products, particularly in areas of unmet need.
2. Shaping the future of medical technologies
Having supported previous revisions of European Directives on devices and diagnostics, the ESC is now actively engaged with the ongoing revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). The system can be complex, with dozens of Notified Bodies deciding whether new technologies should receive the CE-mark – the essential seal of approval which allows products to be sold on the European market. Ensuring that the voices of experts inform this process is a key goal.
"We want to contribute our expertise to the revision of these Regulations so that approval is streamlined and future-proofed," Prof. Kirchhof says. "Europe needs a system that assures patient safety, and the safety of patient data, while speeding up assessment and facilitating approval of innovative devices, including digital devices."
The ESC Regulatory Affairs Committee is also working on a list of critical cardiovascular devices which will help to ensure continuity of access to life-saving medical products for European patients.
3. A new era for data and digital health
The swift and safe adoption of digital devices and validated AI tools could have a transformative effect on cardiovascular care. Ensuring the effective and coherent application of these frameworks will be a key area for health and regulatory experts. "The cardiovascular community is well placed to inform the responsible use of AI," Prof. Kirchhof says. "By devising suitable guardrails, protecting patient data and accelerating assessments, digital tools can save lives."
The public is broadly willing to share health data with trusted professionals and organisations, but reluctant to hand over sensitive information to companies or entities they do not know. Implementing firm and consistent rules on the use of data is essential to unlocking its potential. "That is why we need greater clarity on the regulation of digital devices, notably in areas where the MDR and the AI Act overlap," he explains.
4. Taxing toxic nicotine products
Modernising tobacco legislation is a flagship initiative of the EU Safe Hearts Plan, published in December 2025. The Plan covers not only traditional forms of tobacco, but also newer nicotine-containing products which are toxic to the heart and blood vessels.
The European Chronic Disease Alliance, of which the ESC is a member, has provided the European Commission with a set of recommendations to address the epidemic of young people using vapes and other novel products. These include flavour bans, plain packaging and a complete ban on advertising across all platforms.
Taken together, these four key topics illustrate the value of the ESC's continuous efforts to bring cardiovascular science to the EU's regulatory and policy agenda. The rewards will be evidence-informed policies that drive better health.