This Week in European MedTech - Week 1 October 2025

The major stories in the world of European MedTech this week are dominated by regulatory activity under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), a significant European Commission "Call for Evidence" for future reforms, and fresh funding for companies focused on connected and remote monitoring devices.

Here are the top stories:

1. Regulatory Pressure and Calls for MDR/IVDR Reform

The central theme this week is the ongoing industry push for revisions and accommodations within the European Union's medical device regulations (MDR/IVDR):

EU Call for Evidence for MDR/IVDR Future: The European Commission launched a "Call for Evidence" on the future of the MDR/IVDR, specifically a targeted revision aimed at reducing administrative burden, improving predictability, and enabling digitalisation. The deadline for industry feedback is October 6, 2025, making this the most time-sensitive policy story this week.

MedTech Europe's Push for Immediate Action: The industry body, MedTech Europe, continued to press the EU for immediate regulatory changes by early 2026. Their requests include:

A targeted postponement of re-certification requirements for devices already certified under the existing regulations to avoid a "new major bottleneck" before the 2028 deadline.

The creation of a single, accountable governance structure to oversee the network of Notified Bodies (NBs), aiming to ensure a more efficient and globally competitive CE-marking system.

The launch of planned pilots for expedited regulatory pathways for orphan, pediatric, and breakthrough devices.

Regulatory Milestones: The industry saw updates on several detailed compliance issues:

Confirmation of the Master UDI-DI (Unique Device Identification) implementation date for contact lenses being postponed to November 9, 2026.

Publication of new guidance on addressing incomplete Technical Files for IVDR submissions from Team-NB.

Updates on the status of MDR/IVDR implementation and the gradual rollout of the EUDAMED database.

2. MedTech Product Rollout and Commercial Growth

Cardiology Device Rollout: Elixir Medical began its full European rollout of the LithiX high-capacity Intravascular Lithotripsy (IVL) device following its CE mark, with over 400 patients already treated across 16 countries. This marks a significant market entry for a new cardiology technology.

3. Key MedTech Funding and Expansion

Recent funding activity highlights strong investment interest in both digital and hardware-based medical solutions:

Remote Monitoring Device Funding: RDS (France) raised 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.

AI for Veterinary MedTech: 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 into adjacent healthcare sectors.

Big Tech Investment in Surgical Robotics: Medtronic plc announced it is doubling its London presence to create a global hub for surgical robotics and AI, aligning with the ambitions of the NHS 10-Year Health Plan.

4. Broader Context and Industry Movement

Staffing and Leadership: Dentsply Sirona appointed a new EVP & Chief Commercial Officer to align its global business units with commercial execution, with the new executive bringing extensive experience from J&J MedTech.

Global Trade Impact: European medtech firms are closely watching the potential impact of a US Section 232 investigation and its potential to introduce tariffs, particularly monitoring whether it could override the Nairobi Protocol, which bans tariffs on products for people with disabilities.

To discuss how Nelson Advisors can help your HealthTech or MedTech company, please email [email protected]