Medical technologies in defence and aerospace: Key themes and emerging questions in regulation

In brief

• The EU and the UK are increasingly viewing medical technologies and biotechnology as integral components of their security and defence strategies, both military and civilian, bringing life sciences regulation into direct contact with defence and aerospace frameworks.
   
• For most products, the standard EU and UK life sciences framework (medical devices, IVDs, medicinal products) continues to apply, even when used in military, crisis or space settings. Conversely, products moving from defence to medical need to comply also with the life sciences related regulatory requirements.
   
• Defence and aerospace deployments add further layers, including dual-use and export control, security-driven procurement requirements, shortage prevention mechanisms, data protection and cybersecurity obligations, and emerging AI and biotech initiatives.
   
• In the majority of cases, the familiar EU MDR/IVDR and UK MDR frameworks continue to apply; defence and aerospace contexts typically add discrete, context‑specific obligations around cybersecurity, data handling, platform integration and procurement that can be planned for with proportionate governance.

Background

The convergence of life sciences with the defence and aerospace sectors is accelerating, with medical technologies and medicinal products being increasingly deployed in military, crisis and space settings. This trend gives rise to a number of new regulatory questions especially for manufacturers, suppliers and users of medical technologies, as products are adapted for strategic, non-civilian purposes within a framework that in many respects remains untested.

The experience of the COVID-19 pandemic has demonstrated the importance of rapid innovation and regulatory agility. More recent EU initiatives, including the ongoing preparatory work on a Biotech Act, new defence investment instruments and consultations on quantum technologies, signal a closer integration of health resilience and defence readiness.  Together, these developments bring life sciences regulation into more direct contact with defence and aerospace policy, as technologies originally developed for civilian care are now being used by the armed forces and emergency services. 

In the following sections, we examine  selected regulatory themes that are predominantly emerging in this intersection between  medical technologies, medicinal products and  defence and aerospace.

Key regulatory themes

• Regulatory baseline for medical technologies
  
  Defence or space deployment does not generally disapply Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) in the EU, and with the UK Medical Devices Regulations. Medical devices and in vitro diagnostics must comply with the EU MDR/IVDR and UK MDR. The adaptation of these products for defence or aerospace use may trigger new conformity assessment requirements, especially if the intended use or user population changes. Where wellness or non‑regulated technologies are repurposed for medical use in defence/aerospace, manufacturers should revisit intended purpose, classification and claims to confirm the correct regulatory route. The classification of combination products, sets or installations in vehicles or aircraft can also introduce additional obligations.  Where devices are installed in aircraft, vessels, vehicles or space modules, platform standards (e.g., electromagnetic compatibility, environmental and software assurance) may sit alongside medical device conformity, and should be reflected in the product’s technical documentation. In addition, where medicinal products are integrated into military solutions this may trigger additional requirements for wholesale licences or quality control.
   
• Special deployment environments
  
  Use in extreme or sensitive environments (field hospitals, ships, aircraft, and space) requires that manufacturers ensure that performance claims, labelling and post-market surveillance remain appropriate. Quality management and supply-chain systems, including traceability, necessary authorisations and incident handling, should also take explicit account of deployment in crisis or conflict scenarios. These requirements should be clearly reflected in internal processes as well as in contractual arrangements and risk allocation with partners.
   
• Digital, AI and cybersecurity
  
  Telemedicine, remote monitoring, robotics and AI-enabled decision-support tools for deployed forces do not only trigger life sciences specific regulatory requirements. They have also led to heightened data protection and cybersecurity expectations. The use of AI in medical devices introduces an additional level of complexity. Where AI systems are used exclusively for military purposes, general AI frameworks may be out of scope; however, dual‑use clinical AI would remain subject to medical device and horizontal AI governance.  In practice, aligning device cybersecurity claims with defence‑network security requirements at procurement stage will help reduce mismatches and rework. Manufacturers and operators will need to adapt their compliance frameworks accordingly.
   
• Dual-use and export control
  
  Certain diagnostics, biosurveillance tools and digital platforms may fall within EU and UK dual use or export-control regimes, particularly where their intended use relates to biodefence, preparedness for chemical, biological, radiological or nuclear threats, or sensitive data processing. End‑use and end‑user screening should extend beyond hardware to include software, trained models and datasets.  Early mapping of data/model provenance and cryptographic features helps anticipate whether technology transfers, remote access or support arrangements require control assessments.  This increases the importance of robust internal compliance programmes as well as of systematic end-user and end-use screening.
   
• Supply Chain and Procurement
  
  Supplying medical technologies to defence and aerospace customers often involves more complex procurement frameworks than in civilian healthcare settings, including public procurement rules and defence-specific requirements. Defence procurement can introduce unique acceptance, security classification and support requirements; contracts should be calibrated so that manufacturer, authorised representative, importer and distributor responsibilities are preserved within defence terms without blurring regulatory accountability.  Suppliers must ensure that products and contracts meet both healthcare and defence standards, which may not always align. This can also raise new questions about the roles and responsibilities of economic operators (manufacturers, authorised representatives, importers and distributors). Obligations relating to safety of supply and stock piling may be further considerations in this context.

A developing and complex regulatory environment

The regulatory framework governing medical technologies and medicinal products in defence and aerospace is marked by uncertainty and rapid development. There are many unanswered questions, particularly at the interface of life sciences and defence law, and given that new technologies such as AI and connected devices are deployed in strategic contexts. Legal departments in the life sciences sector should be aware of these evolving issues and consider engaging with regulatory experts who have a strong understanding of both the healthcare and defence/aerospace landscapes.

This is an area where proactive engagement and horizon scanning are essential, as regulatory expectations and enforcement practices continue to develop. Policy attention to the interface between life sciences and security is likely to remain high. The immediate focus for companies should be proportionate documentation and governance for deployments, with targeted horizon scanning to track incremental changes rather than anticipating wholesale regime shifts

Our team

Our dedicated cross-practice team in the EU and the UK brings together specialists in the fields of life sciences, defence and aerospace. We assist companies in navigating regulatory, contractual and compliance issues involving medical technologies and medicinal products in security and defence contexts, particularly where projects straddle the intersection of life-sciences regulation and defence and aerospace policy.