Medical sovereignty is not a slogan

At the Euronews Health Summit last month, I was asked what medical sovereignty means for the medical technology sector. The answer is straightforward: it means ensuring that patients and healthcare professionals can access the technologies they need, when they need them, in routine care and in a crisis. What recent events have made undeniable is that without resilient supply chains, sovereignty is a slogan, not a strategy. 

Europe is the world’s second-largest medtech market. It has a highly skilled manufacturing base and clinical research infrastructure that sets global benchmarks. The challenge is not capability. It is the policy environment around that capability. Regulatory unpredictability and market access barriers, if left unaddressed, risk disincentivising R&D investment and manufacturing decisions away from Europe at exactly the moment when building resilient, sovereign industrial capacity matters most.

Sovereignty and competitiveness are not competing priorities. A Europe that cannot attract and retain medtech investment is not a sovereign healthcare market. It is a dependent one. 

Converging pressures, compounding risk  

In the Middle East, the closure of the Strait of Hormuz forced major carriers to reroute, extending lead times and constraining capacity. The recent announcement of a ceasefire, conditional on the strait’s reopening, has eased immediate pressure, but until passage is restored in practice, the situation remains a moving target and warrants close monitoring. No widespread shortages affecting patient access have been reported in Europe at this stage. Pressure on specialist inputs, notably helium critical to MRI systems, is a particular concern we are tracking with members. 

On trade, the 15% tariff on EU medical technologies exported to the United States has applied since August 2025, and anticipated relief has not materialised. While medical technologies were not targeted in the latest announcements, recent signals of further tariffs on pharmaceuticals confirm that health sector supply chains remain exposed to trade policy volatility.  

These pressures are not isolated. They are converging on a supply chain architecture not designed for sustained geopolitical friction. 

The structural vulnerabilities 

Medtech supply chains are inherently global. That reflects decades of specialisation and the logic of comparative advantage. But it creates dependencies that, when disrupted, move quickly from a logistics problem to a patient access problem.  

Some medical devices require up to 1,000 components sourced globally. Vulnerabilities sit in intermediate goods: rare earth elements in imaging systems, semiconductors in monitoring devices, single-use components manufactured in concentrated geographies. COVID-era shortages of basic supplies such as surgical gloves demonstrated how quickly a narrow supply chain becomes a care disruption. We’ve learned a lot, but the lessons are not yet fully embedded in how Europe plans, procures and stockpiles. Resilience requires diversification, and single-source dependency, wherever it sits, is a structural weakness. 

What sovereignty actually requires 

Sovereignty in medtech is not autarky. Europe cannot, and should not, manufacture every component of every device domestically. What it requires is three things that remain underdeveloped. 

First, genuine supply chain diversification: real optionality across suppliers and geographies, not contingency plans that have never been tested. 

Second, smarter stockpiling: strategies must align at both national and EU level and move beyond emergency procurement to sustainable partnership models. Managed equipment services, with industry partners responsible for rotation, maintenance and logistics, offer a more durable model than static warehousing. Dedicated, long-term funding, separate from healthcare service budgets, is essential.  

Third, and most urgently given the current trade environment, open and predictable trade policy. Protectionist measures on medical technologies do not strengthen European resilience. They undermine it. Medical technologies and their essential inputs must be treated as a protected category in any tariff framework. Retaliatory trade measures that raise costs and reduce market access for the very sector Europe is trying to build sovereign capacity in are self-defeating. 

The regulatory dimension 

Resilience also depends on a regulatory environment that keeps Europe attractive. One in three large manufacturers now deprioritises Europe for first regulatory approval. Over 60% cite administrative burden as the top barrier. For the SMEs that represent around 90% of our sector, that is not a competitive disadvantage. It is an existential threat. When SMEs exit the European market, they take with them specialised, often irreplaceable products that health systems depend on. 

The European Commission’s revision of the Medical Devices Regulation and In Vitro Diagnostics Regulation is a genuine opportunity to change this. The priority now is for the Parliament and Member States to maintain the Commission’s level of ambition. A fit-for-purpose, predictable regulatory framework is not a favour to industry. It is a precondition for the sustained investment that sovereignty actually requires. 

What comes next 

Preparedness must be built before a crisis, not improvised during one. The current convergence of geopolitical instability and trade friction is not an anomaly. It is a structural condition. European health policy must be designed to handle it as such. 

The medtech sector has the expertise, the supply chain visibility and the operational capacity to be a genuine partner in that work. What we need from policymakers is regulatory stability, a trade policy that treats healthcare as a strategic asset, and procurement frameworks that support long-term investment. Medical sovereignty is achievable. The decisions that determine whether it happens are being taken right now.