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This Week in European MedTech and HealthTech: 30th January 2026

  • Writer: Nelson Advisors
    Nelson Advisors
  • 1 hour ago
  • 3 min read

European HealthTech this week is dominated by regulatory fine‑tuning around AI in devices, fresh EU‑level funding calls, and continued capital and grant focus on AI‑enabled care delivery and data platforms.


Regulation and policy


The Commission is positioning the European Health Data Space as a backbone to enable trustworthy AI in healthcare, with a push to turn AI Act and EHDS texts into live deployment projects at the bedside.​


A Commission working paper highlights four flagship AI-in-health initiatives, including EU AI‑powered screening centres and a network of AI deployment expertise, plus actions to speed market entry of medical devices without compromising safety.​


In parallel, a proposed tweak to the AI Act would move MDR/IVDR from Annex I Section A to B, reducing overlap so most AI-enabled medical devices remain high‑risk but are largely governed through MDR/IVDR rather than dual regimes.


EU and national funding windows


Horizon Europe’s 2026–2027 Health Cluster work programme is now live at info‑day level, signalling sizeable calls (often 1.5–10 million euros per project) for digital health, AI, and data‑intensive health R&I from February 2026.


Innovative Health Initiative Call 12 is open, targeting large AI‑driven decision support, mobile health, remote monitoring, interoperability and evaluation projects, with a 21 April 2026 deadline and encouragement of big cross‑sector consortia.


Recent healthtech commentary notes this funding stack alongside Horizon and other schemes as a key driver of European digital health platforms, particularly those built around real‑world deployment and system‑level impact.


Market and strategic themes


Sector analysis this month underlines that capital is available but is flowing selectively into data‑rich platforms, cross‑border models and AI‑enabled diagnostics that can navigate the AI Act / MDR / HTA regime.


Legal and policy advisers in Europe flag 2026–2027 as a crunch period for AI-in-health compliance, with only about 1.5 years left before high‑risk AI obligations in healthcare fully bite, pushing vendors to harden documentation, governance and post‑market monitoring.


To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email lloyd@nelsonadvisors.co.uk


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European MedTech this week is being shaped by MDR/IVDR simplification moves, the hardening EUDAMED timetable, and EU‑level initiatives (including the Biotech Act and IHI Call 12) that favour data‑rich, AI‑enabled devices.


MDR/IVDR and EUDAMED


The Commission’s MDR/IVDR simplification proposal (December 2025) is now being digested, with law‑firm analyses flagging 2026 as the year when portfolio rationalisation and “clean MDR roadmaps” become central to MedTech strategy and M&A.


EUDAMED’s staged rollout has formally triggered transition periods, with full use becoming mandatory by May 2027 and four core modules (actor registration, UDI/device data, notified bodies & certificates, market surveillance) already live, making registration and transparency non‑negotiable for EU device launches.


EU Biotech Act and AI-enabled devices


The new EU Biotech Act package explicitly links AI and data with medical device and biotech innovation, tasking EMA and the Commission with guidance and “AI‑first” coordination across health technologies.


A key Digital Omnibus proposal would move MDR/IVDR from Section A to Section B of Annex I of the AI Act, meaning most AI‑enabled medical devices would primarily comply via MDR/IVDR, easing duplicative AI Act burdens while keeping them high‑risk and tightly supervised.


Funding and strategic signals


IHI Call 12 has opened with large, single‑stage topics including digitalisation and data exchange in healthcare, creating consortium‑style funding opportunities for diagnostics, monitoring, and integrated device‑plus‑data solutions.


Recent European commentary expects M&A and growth capital in MedTech to concentrate on fewer, higher‑quality assets that pair robust MDR/EUDAMED positioning with strong clinical‑economic evidence and AI/data moats, especially in robotics, neuro, advanced diagnostics, and workflow automation.


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Nelson Advisors specialise in Mergers and Acquisitions, Partnerships and Investments for Digital Health, HealthTech, Health IT, Consumer HealthTech, Healthcare Cybersecurity, Healthcare AI companies. www.nelsonadvisors.co.uk


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Nelson Advisors specialise in Mergers and Acquisitions, Partnerships and Investments for Digital Health, HealthTech, Health IT, Consumer HealthTech, Healthcare Cybersecurity, Healthcare AI companies. www.nelsonadvisors.co.uk
Nelson Advisors specialise in Mergers and Acquisitions, Partnerships and Investments for Digital Health, HealthTech, Health IT, Consumer HealthTech, Healthcare Cybersecurity, Healthcare AI companies. www.nelsonadvisors.co.uk

 


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