At the 2025 European Digital Technology and Software Conference in Rotterdam, industry experts expressed growing concern about how the EU Artificial Intelligence Act may challenge the development and approval of AI-enabled medical technologies. While the legislation aims to strengthen oversight of AI systems, medtech leaders worry that the current framework could be too complex and unpredictable for manufacturers, especially smaller companies and startups.
Much of the concern centers on how the AI Act overlaps with existing European regulations, including the Medical Device Regulation. For many developers, it is still unclear which requirements apply, how assessments will be conducted, and whether notified bodies will be ready to evaluate AI-based products. Industry representatives noted that this uncertainty is already causing some companies to shift development to markets outside the EU, slowing access to innovation for European patients.
Despite the challenges, panelists expressed hope that upcoming updates from the European Commission, known as the Digital Omnibus package, may bring needed clarity. Stakeholders are advocating for more practical requirements, predictable timelines, and regulatory pathways that better reflect the realities of AI in healthcare. Others argue that the most effective solution may be to align AI oversight entirely under the existing medical device framework instead of creating a parallel system.
There was also emphasis on the broader goal of ensuring that AI technologies improve health outcomes across diverse populations. Experts highlighted the importance of representative data, transparency in development, and thoughtful evaluation to maintain trust in digital health tools. While opinions differed on how the AI Act should evolve, panelists agreed that patient safety, equity, and responsible innovation must remain central to the conversation.
As the EU prepares to issue further guidance, medtech developers continue to watch closely for adjustments that could ease compliance burdens and provide the predictability needed to bring new technologies to market.
At EMMA International
EMMA International supports medtech organizations as they navigate complex and changing regulatory expectations across global markets. Our team helps manufacturers interpret new requirements, assess regulatory risk, and maintain compliance as AI-driven technologies become increasingly integrated into medical products.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Regulatory Affairs Professionals Society (RAPS). Experts Look for Relief from EU AI Act for MedTech Industry. (2025).
