This Week in European MedTech - Week 3 October 2025

The last week in European MedTech has been dominated by regulatory and funding activities, as well as continued momentum in digital health and surgical innovation.

🇪🇺 Regulatory News and Policy

The central theme continues to be the implementation and potential revision of the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Call for Evidence on MDR/IVDR Reform: The European Commission launched a "Call for Evidence" on the future of the MDR/IVDR, seeking feedback on a targeted revision. The goal is to reduce administrative burden, improve predictability, and enable digitalization in the regulations. This consultation was a major focal point for industry last week.

Industry Push for Action: Industry group MedTech Europe is actively pushing for immediate regulatory changes by early 2026. Key requests include a targeted postponement of re-certification requirements to avoid regulatory bottlenecks and the creation of a single governance structure for Notified Bodies to ensure a more efficient CE-marking system.

UK Regulatory Updates: The UK's MHRA (Medicines and Healthcare products Regulatory Agency) published guidance to help manufacturers prepare for a new device registration fee set to apply from April 1st. They also reported that reforms have more than halved the time it takes to approve clinical trials, falling from 91 days to 41 days.

💰 Funding and Innovation Highlights

Several companies secured funding and advanced commercial rollout of innovative technologies:

Remote Monitoring: French company RDS secured a €14 million Series A round to industrialise and expand its MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe.

Cardiology Device Rollout: Elixir Medical began its full European rollout of the LithiX high-capacity Intravascular Lithotripsy (IVL) device following its CE mark. This rollout follows treatment of over 400 patients across 16 countries.

AI and Robotics Investment: Medtronic plc announced it is doubling its London presence to establish a global hub for surgical robotics and AI, aligning with long-term health plan ambitions in the UK.

AI for Veterinary MedTech: UK startup Lupa raised a €17 million Series A to scale its AI-native operating system for veterinary clinics, demonstrating AI's spread into adjacent healthcare sectors.

🌐 Global & Other European MedTech Updates

FDA Inspection Reliance: The European Medicines Agency (EMA) has begun accepting the FDA's findings from inspections of manufacturing facilities conducted outside the US, a significant step toward international regulatory harmonisation.

Pharmaceutical Cost Debate: Under the UWWTD's (Urban Waste Water Treatment Directive) extended producer responsibility scheme, pharmaceutical and cosmetics industries will be required to contribute to wastewater treatment costs. This plan has received pushback from major European drugmaker trade groups.

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