This Week in European HealthTech and MedTech: 30th December 2025

European HealthTech this week is centred on EHDS data‑sharing rules, EU‑level digital health funding, and continued AI‑heavy startup investment across the continent. UK NHS digital programmes and EU grant schemes are also shaping demand signals for virtual care, AI triage, and infrastructure plays going into 2026.​

EHDS and data governance

The European Health Data Space Regulation, entering into force in 2025, creates a common framework for primary and secondary use of health data, with phased milestones from 2025–2029 for cross‑border exchange and secondary research use.​

Member States must stand up National Digital Health Authorities and Health Data Access Bodies, enabling federated access via HealthData@EU and opening new opportunities for AI, RWE and digital therapeutics vendors.​

EU digital health strategy and events

Recent EU communications highlight that all Member States now provide some form of electronic health record access, with accelerated investment in e‑prescriptions, AI integration and digital governance to boost productivity and resilience.​

High‑profile European digital health summits have focused on EHDS, cross‑border EHR interoperability and “One Health” data strategies, underlining that rules and governance, not core technology, are now the main bottleneck for scale.​

UK NHS digital and virtual care

A new UK reference guide from NHS Confed and national digital programmes outlines up to £10 billion in NHS technology and digital transformation spending by 2028/29, with priorities around the NHS App, virtual wards and AI infrastructure.​

The NHS App is being positioned as the single gateway to services, with integration of wearables, remote monitoring and AI‑powered advice/triage tools, creating a favourable environment for UK‑ and Europe‑focused HealthTech vendors.​

Funding, grants and AI focus

EU programmes such as EU4Health and Digital Europe have earmarked substantial digital health funding, particularly for AI, interoperability, cybersecurity and cross‑border infrastructure, often blended with VC rounds as non‑dilutive capital.​

2025 funding analyses show multi‑billion‑euro HealthTech capital deployment in Europe, with a clear tilt toward AI‑driven ventures and infrastructure (data platforms, workflow tools), supported by reimbursement schemes like DiGA and similar national models.

Ecosystem initiatives and calls

EIT Health’s 2025 “Digital Transformation of Healthcare” flagship call is steering funding into patient‑centred digital health solutions and evidence generation for CE‑marked digital medical devices entering EU markets.​

EU‑backed projects such as DigitalHealthEurope and related EHDS implementation initiatives continue to feed standards and policy recommendations, shaping market access conditions for HealthTech vendors across Member States

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European MedTech this week is dominated by MDR/IVDR regulatory moves around EUDAMED, EU innovation/health packages, and continued capital formation for MedTech and digital health scale‑ups heading into 2026. Imaging, AI platforms, and late‑stage MedTech funding vehicles remain key themes, with Europe‑focused co‑investment structures and hospital‑facing workflow innovation in focus.​

Regulation and MDR/IVDR moves

The European Commission is progressing a broader health and innovation package that includes targeted simplification of MDR/IVDR, aiming for a more efficient and predictable system for device approvals.​

A central element is phased mandatory application of EUDAMED modules, tightening post‑market surveillance, vigilance and economic operator registration, while still trying to avoid supply disruptions for legacy devices.​

EUDAMED and legacy timelines

From 2025, Regulation (EU) 2024/1860 introduces new information obligations, stepwise activation of EUDAMED modules, and extended transition periods for many legacy devices and IVDs.​

Legacy IVDs can now stay on the market up to 2027–2029 depending on risk class, while many higher‑risk legacy devices under MDD/AIMDD have transition windows to 2027–2028, easing near‑term cliff‑edge risks for manufacturers.​

Capital formation and funding

A €150 million co‑investment vehicle between the European Investment Bank and Angelini Ventures (€75 million each) is being finalised to support 7–10 European biotech, MedTech and digital health companies at market‑launch/scale‑up stage.​

Broader 2025 analyses show multi‑billion‑euro healthtech funding in Europe, with most recent capital flowing into AI‑driven ventures and digital infrastructure, supported by EHDS‑aligned policies and national reimbursement schemes such as DiGA‑style frameworks.​

Market and M&A signals

Commentators tracking 2025 MedTech dealflow note ongoing strategic consolidation, particularly in areas like ophthalmology clinics and robotics, as platforms seek pan‑European scale and integrated care models.​

There is a visible tilt toward later‑stage, infrastructure‑heavy assets and imaging/diagnostics software, as hospital buyers prioritise workflow integration and data platforms over point solutions.​

Imaging, AI and hospital IT

European majors such as Siemens Healthineers and Philips are pushing next‑generation MRI/CT with deeply embedded AI and energy‑efficiency features, reinforcing Europe’s strength in high‑end imaging systems plus software.​

Consolidation in imaging IT (e.g., large‑cap acquisitions of PACS/VNA and advanced imaging software vendors) is reshaping the competitive landscape in EU hospitals, intensifying rivalry with incumbents like Agfa and Sectra on enterprise imaging platforms.

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