This Week in European HealthTech and MedTech: 23rd December 2025

The biggest European MedTech developments this week centre on EU regulatory reform under MDR/IVDR and fresh late‑stage capital aimed at European MedTech scale‑ups.​

EU MDR/IVDR revision and simplification

The European Commission has proposed a targeted simplification of the Medical Device and IVD Regulations to make conformity assessment faster, less bureaucratic and more innovation‑friendly, while maintaining safety.​

Changes focus on digitalising procedures, improving EUDAMED, easing the transition for “legacy” devices and addressing bottlenecks caused by limited notified‑body capacity, after strong industry pressure that current rules were stifling MedTech innovation.​

Capital for MedTech and digital health scale‑ups

A €150m co‑investment vehicle (50% European Investment Bank, 50% Angelini Ventures) has been confirmed to finance European biotech, MedTech and digital health companies at market‑launch/scale‑up stage, directly targeting the Series‑B “valley of death”.​

Weekly funding analyses show Europe attracting multi‑billion‑euro healthtech investment in 2025, with capital concentrating in AI‑enabled diagnostics, digital infrastructure and value‑based care platforms that can benefit from clearer EU rules and reimbursement pathways.​

MDR certification and market access milestones

Shape Memory Medical secured EU MDR Class III certification for its IMPEDE embolisation plug family, underscoring that complex interventional devices can clear the stricter regime and secure long‑term EU market access.​

Commentators note that MDR certifications like this increasingly rely on robust real‑world performance data and registries, signalling that post‑market evidence has become a decisive competitive asset for European MedTech players.

European HealthTech this week is dominated by EU‑level policy moves around data and AI plus continued capital formation and grant activity supporting digital health scale‑ups.​

EU health data and AI framework

The Regulation establishing the European Health Data Space (EHDS) is now in force, creating a harmonised framework for primary and secondary use of electronic health data and enabling cross‑border sharing via the MyHealth@EU infrastructure.​

In parallel, the Commission’s Digital Omnibus and AI‑focused health package aim to align AI Act obligations with MDR/IVDR and simplify digital and AI rules for health technologies, reducing fragmentation for HealthTech builders.​

Funding and scale‑up capital

A €150m co‑investment vehicle from the European Investment Bank and Angelini Ventures has been confirmed to back 7–10 European biotech, MedTech and digital health companies at market‑launch/scale‑up stage, directly targeting the Series‑B funding gap.​

Broader 2025 funding analyses show multi‑billion‑euro flows into European digital health, with around 60% of recent capital going to AI‑driven ventures and infrastructure platforms benefiting from EHDS and clearer reimbursement paths (e.g. DiGA‑style schemes).​

Grants, calls and ecosystem activity

EIT Health’s 2025 Flagships call is directing funding to patient‑centred digital health solutions and evidence‑generation projects that help CE‑marked digital medical devices enter new EU markets.​

EU‑level programmes like EU4Health, Digital Europe and Horizon Europe continue to allocate substantial non‑dilutive funding to digital health infrastructure, AI and interoperability, with new maps and guidance published to help innovators navigate these instruments.

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