News

The European Union is conducting a large-scale review of digital regulation, announced in 2025, which aims to simplify and streamline regulation for business and individuals alike, and boosting competitiveness and lowering ultimate cost.

Medical AI moves from AI Act into MDR

One of the most anticipated changes is the way that medical AI devices will be assessed. If the rules enter into force, Medical Device AI will no longer be assessed as part of the AI Act, but directly as part of the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) conformity assessment procedures.

Guidance and support for SMEs

For SMEs, the biggest challenge now is uncertainty – timelines are shifting, requirements are changing, and enforcement in part is delayed. In this context, there is a growing need for practical guidance, testing, and validation support to bridge the gap between high-level regulation and real-world implementation. TEF-Health, as an EU-wide initiative and recognised implementation support instrument under the AI Act, is addressing this need by providing guidance to SMEs and staying updated on the latest changes.

This session will introduce CHU de Rennes and CHU Grenoble Alpes virtual testing infrastructures and digital validation services supporting SMEs in preparing AI-driven medical technologies for regulatory compliance and market readiness.

You will gain insights into:

• AI model validation & performance testing
• Data-based evidence generation
• Regulatory preparation before clinical deployment

How to deploy trustworthy AI in healthcare was the topic of the day when clinicians, innovators, representatives from industry and academia met with decision-makers and funders at an event highlighting real-world experiences of AI development and implementation in healthcare. The event also showcased new models of co-creation between healthcare providers and industry, to lay the foundation for more ethical, effective, and collaborative AI innovation across Europe.

Researchers at Karolinska Institutet, the Centre for Imaging Research (CIR), SciLifeLab, and RISE have together received a grant of over SEK 100 million from the European Commission's Digital Europe programme. The project, called TEF-Health, will, among other things, promote the rapid introduction of new artificial intelligence (AI) and robotics solutions in healthcare.