This Week in European HealthTech and MedTech: 19th December 2025
- Nelson Advisors
- 4 hours ago
- 5 min read
The biggest European MedTech developments this week centre on the EU’s proposed overhaul of MDR/IVDR, a broader Commission health package to boost innovation and resilience, and continued capital formation for MedTech and digital health scale‑ups.
Together these moves signal a more innovation‑friendly regulatory path and fresh growth funding for European MedTech heading into 2026.
MDR/IVDR targeted revision
The European Commission has proposed a targeted simplification of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to make rules easier, faster and more effective while maintaining high patient safety.
MedTech Europe welcomed the proposal as a “long‑awaited and necessary step” to fix parts of the system that are not working for patients, innovators and providers, highlighting the need to reduce bureaucracy and restore Europe’s competitiveness in MedTech.
Wider EU health package
The MDR/IVDR revision forms part of a broader Commission package of new measures aimed at creating an innovative and resilient health sector that delivers better outcomes across the EU.
This package sits alongside initiatives like the Digital Omnibus and other digitalisation efforts, signalling a coordinated push to streamline health regulations, support data‑driven technologies and modernise procedures for medical technologies.
Digital and AI regulatory alignment
The Digital Omnibus proposals seek to rationalise how AI Act obligations interact with MDR/IVDR, as well as streamline data protection, cybersecurity and reporting frameworks that directly affect MedTech companies.
Legal and policy analyses point out that this combination of Digital Omnibus and MDR/IVDR revision is intended to reduce regulatory fragmentation and over‑regulation that have been criticised for slowing innovation in European MedTech.
Capital formation and scale‑up funding
A €150 million co‑investment agreement between the European Investment Bank and Angelini Ventures, with €75 million from each, has been confirmed to finance European startups in biotechnology, MedTech and digital health.
The vehicle aims to support seven to ten innovative European companies at market‑launch stage, directly addressing the late‑stage “valley of death” for MedTech and digital health scale‑ups.
Operational and implementation themes
Ongoing work around EUDAMED and MDR/IVDR implementation, including stepwise activation of database modules and extended transition periods for legacy devices, continues to shape day‑to‑day compliance planning for manufacturers and hospitals.
These implementation changes are designed to prevent supply disruption while collecting better data on device availability, which will inform further tweaks to the regulatory framework through 2025–2026
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European HealthTech this week is defined by the Commission’s new health package and EHDS rollout, ongoing EU‑level digital health strategy, and continued investor focus on AI‑driven platforms and infrastructure. These themes reinforce a policy and funding environment that is increasingly supportive of data‑intensive HealthTech business models across the continent.
EU health package and digitalisation
The European Commission has proposed new measures to create an innovative and resilient health sector that “delivers for patients”, with digitalisation and data use as central pillars.This sits alongside broader EU digital health work, where priorities include secure cross‑border access to health data, shared data infrastructure for personalised medicine, and citizen empowerment with digital tools.
European Health Data Space (EHDS)
Regulation (EU) 2025/327 formally establishing the European Health Data Space is now in force, laying down obligations for primary and secondary use of electronic health data across public and private actors.
EHDS is expected to be structurally disruptive for HealthTech, enabling new business models in data‑driven care, research and AI, supported by a central MyHealth@EU interoperability platform for cross‑border EHR and e‑prescription exchange.
EU funding and grant environment
The EU has earmarked significant funding for digital health through programmes such as EU4Health and Digital Europe, with a strong focus on AI, interoperability, cybersecurity and cross‑border digital infrastructure.
Specialist round‑ups highlight EU grants in 2025 targeting AI in healthcare, mental health and pandemic preparedness, providing non‑dilutive capital that can be blended with VC rounds for HealthTech startups.
Market and investment signals
Analyses of the 2025 HealthTech investment landscape show Europe attracting multi‑billion euro funding with healthtech among the most funded sectors, helped by EHDS and supportive digital policies.
Funding commentators emphasise that roughly the majority of recent digital health capital is flowing into AI‑driven ventures and infrastructure plays, with reimbursement frameworks like DiGA and similar schemes in France and the Nordics seen as critical for scale‑up.
Ecosystem initiatives and calls
EIT Health’s 2025 “Digital Transformation of Healthcare” flagship call is directing money toward 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 initiatives continue to feed recommendations into EHDS implementation, standards and coordination, shaping the environment for HealthTech vendors selling into national systems.
Nelson Advisors > MedTech and HealthTech M&A
Nelson Advisors specialise in mergers, acquisitions and partnerships for Digital Health, HealthTech, Health IT, Consumer HealthTech, Healthcare Cybersecurity, Healthcare AI companies based in the UK, Europe and North America. www.nelsonadvisors.co.uk
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