Medical Technologies in Defence and Aerospace: Key Themes and Emerging Questions in Regulation

• Security focus: The EU and UK increasingly view medical technologies and biotechnology as integral to security and defence, bringing life sciences regulation into direct contact with defence and aerospace frameworks.
• Core rules still apply: For most products, the standard EU/UK life sciences regimes (MDR/IVDR/medicinal products) continue to apply even in military, crisis or space settings. Products moving from defence to medical must meet life‑sciences requirements.
• Additional layers: Defence/aerospace deployments add dual‑use and export controls, security‑driven procurement, shortage‑prevention, data protection and cybersecurity duties, plus emerging AI/biotech initiatives.
• Practical takeaway: The familiar MDR/IVDR and UK MDR remain the baseline; defence/aerospace contexts add targeted, context‑specific obligations around cybersecurity, data, platform integration and procurement that can be managed with proportionate governance.

Life sciences and defence/aerospace are converging as medical technologies and medicinal products are deployed in military, emergency and space settings. COVID‑19 underscored the need for rapid innovation and regulatory agility. New EU initiatives (including the draft Biotech Act, defence investment instruments and consultations on quantum technologies) signal closer alignment between health resilience and defence readiness. This raises novel questions for manufacturers, suppliers and users as civilian technologies are adapted for strategic purposes in relatively untested regulatory interfaces.

• Regulatory baseline for medical technologies

Defence or space use does not generally disapply the EU MDR/IVDR or UK MDR. Adapting products for defence/aerospace may trigger new conformity assessments, particularly where intended use or user population changes. Repurposing wellness/non‑regulated tech for medical use requires revisiting intended purpose, classification and claims. Installation in aircraft, vessels, vehicles or space modules brings platform standards (e.g., EMC, environmental, software assurance) alongside medical conformity, to be reflected in technical documentation. Integration of medicinal products may require additional wholesale or quality‑control authorisations.

• Special deployment environments

Extreme or sensitive environments demand that performance claims, labelling and post‑market surveillance remain appropriate. Quality management and supply chains should explicitly account for crisis/conflict deployment, with traceability, authorisations and incident handling embedded in internal processes and contracts, including clear risk allocation.

• Digital, AI and cybersecurity

Telemedicine, remote monitoring, robotics and AI decision‑support trigger life‑sciences, data protection and cybersecurity requirements. Military‑exclusive AI may fall outside general AI frameworks, but dual‑use clinical AI remains subject to medical device and horizontal AI governance. Align device cybersecurity claims with defence‑network requirements at procurement to avoid rework, and adapt compliance frameworks accordingly.

• Dual-use and export control

Diagnostics, biosurveillance and digital platforms can fall under EU/UK dual‑use or export controls, especially for biodefence, CBRN preparedness or sensitive data processing. End‑use/end‑user screening should cover hardware, software, trained models and datasets. Early mapping of data/model provenance and cryptography helps anticipate licensing needs for transfers, remote access or support. Robust internal compliance programmes and systematic screening are essential.

• Supply Chain and Procurement

Defence procurement introduces unique acceptance, security classification and support requirements. Contracts should preserve manufacturer/authorised representative/importer/distributor responsibilities without blurring regulatory accountability. Suppliers must meet both healthcare and defence standards, which may diverge, and address safety‑of‑supply and stockpiling obligations.

• A developing and complex regulatory environment

Expect continued policy attention and evolving enforcement at the life sciences–security interface. Companies should prioritise proportionate documentation and governance for deployments, with targeted horizon scanning to track incremental change rather than wholesale regime shifts.