A targeted assessment of the EU’s Medical Device and IVD Regulations will be completed by the end of 2025 to find solutions to support medical device innovation without compromising patient safety and to improve the competitiveness of the European medtech industry.
EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

More from Medtech Insight
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department. Experts questioned whether the cuts could be implemented without harming FDA’s core mission.
Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.
The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."