ESC CRT Roundtable
Industry Perspective on the Evolution of EU Medical Device Regulation: Insights from Brussels
On 17–18 April 2024, Brussels hosted the plenary meeting “Priorities for the Evolution of Medical Device Regulatory Approval Systems,” bringing together key stakeholders to discuss the future of medical device regulation in Europe. The two-day event focused on critical objectives, including:
- Harmonization of global medical device regulations
- Opportunities for priority access to health technology innovation
- Regulatory considerations for orphan devices
This meeting served as a follow-up to a previous event held in November 2022, continuing the dialogue on how regulatory frameworks can better support innovation while safeguarding patient safety.
Industry Contribution
Andrea Rappagliosi from Edwards Lifesciences delivered an oral presentation offering an industry perspective on the EU medical device regulatory system and how it should evolve. His insights emphasized the need for streamlined processes that enable faster access to innovative technologies without compromising compliance and patient safety.
Why This Matters for HEU-EFS
The HEU-EFS Project is deeply aligned with these goals. By promoting a harmonized approach to Early Feasibility Studies (EFS) for medical devices, the project seeks to integrate patient perspectives into the design and evaluation of future cardiovascular therapies. This ensures that innovation translates into meaningful patient benefit, while supporting a lifecycle approach to clinical evidence generation.
The CRT meeting provided a powerful platform to showcase this vision and engage with regulators, industry leaders, and healthcare stakeholders shaping the future of cardiovascular regulation in Europe.
Events like this highlight the importance of collaboration between regulators, industry, and research organizations to create a regulatory environment that fosters innovation and improves patient outcomes.