This Week in European MedTech and HealthTech: 23rd January 2026

Nelson Advisors
14 minutes ago
5 min read

**This Week in European HealthTech and MedTech: 23rd January 2026**

European HealthTech this week is being shaped by fresh EU-level funding calls for digital health and AI, tightening but slightly simplified device and AI regulation, and continued emphasis on compliance‑driven M&A and scaling of AI decision‑support. Capital is available but flowing selectively into data‑rich platforms, cross‑border care models, and AI‑enabled diagnostics that can navigate the emerging AI Act / MDR / HTA stack.

Policy and regulatory moves

The EU’s 2026 Health Technology Assessment work programme is ramping up, with around 50 joint clinical assessments planned for medicines and high‑risk devices, raising the bar for evidence and pan‑EU launch planning.

Draft MDR/IVDR simplification removes the five‑year certificate validity cap and shifts toward continuous, risk‑based surveillance, aiming to ease bottlenecks while tightening expectations on cybersecurity, documentation and post‑market data.

New EU‑wide cybersecurity obligations via the Cyber Resilience Act and device‑specific rules will push connected devices, SaMD and apps to treat security and incident reporting as core compliance work streams, not optional add‑ons.

EU and national funding windows

The Innovative Health Initiative’s “Call 12” opened this week, offering large‑ticket funding for AI‑driven decision support, mobile health, remote monitoring and interoperability projects, with submissions due in April 2026.

The 2026 Future of Health Grant cycle is opening for early‑stage digital health startups in Switzerland, targeting telemedicine, preventive care, patient analytics and digital therapeutics as priority themes.

Horizon Europe’s 2026–2027 work programme earmarks a meaningful slice of a €14bn envelope for health and digital technologies, reinforcing EU‑level co‑funding for data, AI and platform‑centric HealthTech.

Market, adoption and M&A signals

Expert commentary this week frames European MedTech and HealthTech as entering a “compliance‑driven M&A” phase, where acquisitive strategics buy smaller players as much for regulatory approvals and MDR‑ready infrastructure as for the underlying tech. Nelson Advisors highlights this as a core 2026 pattern.

Adoption of AI‑powered clinical administration (ambient voice, AI scribes, workflow tools) is expected to become widespread in European clinical settings, with usage governed tightly by the EU AI Act and national health‑system guidelines.

Broader European thought‑pieces position 2026 as the year digital health moves from pilots to scaled deployment, but with investor selectivity increasing around real‑world data, interoperability and reimbursement readiness.

Country‑level highlights (UK and DACH focus)

In the UK, planned “Innovator Passports” should allow HealthTech validated in one NHS organisation to scale across others without repeating assessments, directly benefiting proven digital tools and AI platforms.

The UK is also backing an AI research‑screening platform and expansion of surgical robotics aligned with NICE guidance, signalling sustained appetite for AI‑enabled diagnostics, workflow tools and high‑acuity MedTech.

Swiss‑backed programmes such as the Future of Health Grant continue to position Switzerland as a hub for early‑stage digital health, offering non‑dilutive capital that can be leveraged alongside VC for telemedicine and analytics plays.

Signals for dealmakers and operators

Regulatory simplification plus tougher HTA and cybersecurity rules make evidence generation, interoperability and cyber‑hardening central value drivers in valuations and due diligence.

Portfolio reviews at strategics are likely to favour targets that combine MDR/IVDR‑ready status with AI or data moats, enabling acquirers to “buy compliance” and accelerate EU‑wide scale under the new regime.

For founders, the live IHI and Horizon calls provide a window to de‑risk capital plans for data‑heavy or

infrastructure‑like platforms, especially if structured around cross‑border consortia and HTA‑aligned clinical programmes

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European MedTech this week is defined by tightening but clearer MDR/IVDR and EUDAMED timelines, a visible “compliance‑driven M&A” narrative, and at least one notable cross‑border platform acquisition alongside continued interest in cardiology and AMR‑linked devices. Regulatory simplification is easing some bottlenecks while making cyber, data and AI readiness central to value, due diligence and portfolio strategy.

Regulation and guidance

The Commission’s late‑2025 MDR/IVDR “simplification” package is setting the 2026 agenda, targeting notified‑body bottlenecks and shifting toward more risk‑based, continuous surveillance while keeping high evidence expectations.

EUDAMED has four functional modules live, with a six‑month transition to full mandatory use by 28 May 2026, making registration and vigilance data a non‑negotiable gateway for EU market access.

New draft rules and guidance sharpen expectations around software, AI‑enabled devices and cybersecurity, aligning MDR/IVDR with the AI Act and broader “Digital Omnibus” data framework from 2026 onwards.

Funding rounds and capital flows

French MedTech FineHeart has raised around €83m (mix of private and European public capital) to advance its implantable device for advanced heart failure, underlining persistent appetite for complex cardiovascular hardware plus data.

Eindhoven‑based ShanX Medtech has secured roughly €24m to scale ultra‑rapid AMR diagnostics, reinforcing antimicrobial resistance as a strategic EU theme and the Netherlands as a diagnostics hub.

Weekly deal wraps continue to place these cardiology and AMR diagnostics financings among the top European MedTech startup transactions in early January, setting a strong tone for Q1 2026 fundraising.

M&A and strategic moves

Sector commentary highlights a growing pattern of “compliance‑driven M&A”, as larger strategics acquire smaller players partly to secure MDR/IVDR‑ready product lines and regulatory approvals as financial assets.

G Square has acquired a majority stake in Finnish MedTech company Serres from Paree Group, with the partners aiming to develop Serres into a leading international platform via new product investment and global expansion.

US investors are reported to be increasingly active in European robotics and AI‑enabled MedTech, seeking exposure before valuations converge with US peers, which supports cross‑border growth and exit options.

Market and adoption themes

Analysts frame 2026 European MedTech growth around AI‑supported workflows in cardiovascular, neurovascular, advanced diagnostics and surgical robotics, designed to plug into emerging European health data infrastructures.

EUDAMED‑driven transparency on actors, certificates and vigilance is expected to raise payer scrutiny and to hard‑wire regulatory quality into commercial and M&A evaluations.Trade bodies continue to push for pragmatic implementation of MDR/IVDR timelines and notified‑body rules to avoid device shortages, while broadly supporting reforms that are innovation‑friendly but well governed.

Implications for dealmakers and operators

Evidence generation, real‑world performance data, and cyber/AI governance are becoming central value drivers in MedTech transactions, not hygiene factors.

For acquirers, MDR/IVDR‑ready portfolios and EUDAMED clean data create opportunities to “buy compliance” and accelerate pan‑EU scale; for founders, this favours device‑plus‑data platforms with clear regulatory narratives.

Funding and M&A activity indicate particular strength in high‑acuity cardiology hardware and AMR diagnostics, suggesting these niches will remain heavily competed for capital and strategic interest.

Nelson Advisors > European MedTech and HealthTech Investment Banking

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 regularly publish Thought Leadership articles covering market insights, trends, analysis & predictions @ https://www.healthcare.digital

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