This Week in European MedTech - Week 2 October 2025

Major developments in European MedTech this week focused on regulatory turbulence and the industry's coordinated pressure for immediate reform of the EU's medical device laws.

The central theme is the European Commission's "Call for Evidence" on the future of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

1. Intense Pressure for MDR/IVDR Legislative Reform

The key development is the industry's comprehensive and unified response to the European Commission's public consultation, with MedTech Europe leading the charge:

Urgent Call for Structural Change: MedTech Europe, the industry's trade body, strongly advocated for a systematic and structural revision of both the MDR and IVDR. They assert that the current regulations have "structural problems" that are making regulatory processes slow, unpredictable, costly and complex, leading to a drain of innovation from Europe.

Need for Centralised Governance: A major proposal from the industry is the creation of a single, accountable and dedicated governance structure at the EU level. This body would oversee the decentralised network of Notified Bodies (NBs), aiming to harmonise decisions and increase the efficiency of the CE-marking system.

Bridging Measures Requested: The industry is pushing for immediate, short-term relief measures (bridging measures) to mitigate the current risks, including:

Postponement of Re-certification: A targeted delay for devices already certified under the old directives to avoid a "new major bottleneck" before the 2028 transitional deadlines.

Fast-Track Pathways: The establishment of an accelerated, 120-day pathway for breakthrough, orphan, and paediatric devices in areas of unmet medical need.

2. Product and Market Expansion

Despite the regulatory backdrop, companies continue to secure funding and expand their commercial presence:

Cardiology Device Rollout: Elixir Medical began its full European commercial rollout of its LithiX Intravascular Lithotripsy (IVL) device following its CE mark. This indicates a significant market entry for a new technology designed to treat calcified coronary arteries.

Remote Patient Monitoring (RPM) Funding: RDS (France) secured a €14 million Series A funding round. The capital is aimed at industrializing and expanding the rollout of its MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe, highlighting strong investor interest in connected health hardware.

3. AI and Robotics Investment Hubs

Investment into advanced MedTech infrastructure remains high:

Medtronic's Robotics Hub: Medtronic plc announced plans to double its London presence to create a global hub for surgical robotics and AI. This action underscores the long-term strategic commitment of major global MedTech players to anchor their advanced technology development within Europe, leveraging the region's talent pool.

AI for Adjacent Sectors: Lupa (UK) secured a €17 million Series A to scale its AI-native operating system for veterinary clinics and launch a dedicated Veterinary AI Lab in Europe, demonstrating the spread of MedTech innovation models into parallel healthcare sectors.

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