Medical devices

EMA publishes ACT EU draft guidance on clinical trials during public health emergencies and opens consultation

The European Medicines Agency (EMA) has published draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative on the conduct of clinical trials during public health emergencies (PHEs). The guidance, which is now open for stakeholder consultation, recommends a harmonised approach to ensure trials can be initiated, adapted and continued efficiently and safely when emergencies arise. It outlines regulatory mechanisms to accelerate authorisation of new clinical trials and approve modifications to ongoing trials during a PHE and encourages sponsors to seek scientific advice from EMA’s Emergency Task Force (ETF) to support well‑designed trials capable of generating meaningful clinical evidence. It also addresses circumstances in which trial participants may need to be transferred across investigational sites, noting that adapted procedures may be required due to PHE‑related challenges, while emphasising that the rights, safety and well‑being of trial participants and the production of scientifically robust evidence remain central to regulatory decisions. The consultation closes on 30 April 2026.

DHSC publishes 3-year review of genetic testing and insurance code

The Department of Health and Social Care (DHSC) has completed its review of the Code on Genetic Testing and Insurance and has set out the actions to be taken to ensure the Code remains fit for purpose in light of developments in genetics and insurance.

Life Sciences weekly highlights—5 March 2026

This week's edition of Life Sciences weekly highlights includes: the DHSC published its response to proposed amendments to the NICE cost-effectiveness threshold regulations which will come into force 24 March 2026, in advance of the increased thresholds anticipated for April, and it has issued the England Rare Diseases Action Plan 2026 extending the UK Rare Diseases Framework to January 2027. At EU level, the Commission launched a consultation on draft guidance under the Cyber Resilience Act, EFPIA and Medicines for Europe called for a pause to the extended producer responsibility scheme under the revised Urban Wastewater Treatment Directive and Team-NB and the International Medical Device Regulators Forum (IMDRF) published updates concerning the MDR/IVDR and regulatory reliance for medical devices. In addition, the European pharmaceutical industry highlighted progress in rare disease research under IMI and IHI projects, the Health Research Authority (HRA) launched a pilot information governance guide for research approvals and the Commission adopted a recommendation on diagnostic reference levels for medical radiation procedures.

Commission and Switzerland sign package of agreements to deepen and expand cooperation

The European Commission and the Swiss Confederation have signed a broad package of agreements to deepen and expand the EU-Switzerland relationship. The package aims to provide legal certainty and simplify trade in goods such as medical devices and food products by aligning standards and rules in closely integrated areas. It also introduces a new health agreement enabling Switzerland to participate in EU mechanisms and bodies addressing serious cross-border threats to health, including the European Centre for Disease Prevention and Control and the Early Warning and Response System. Furthermore, the agreement opens the way for Switzerland to take part in Horizon Europe, Euratom Research and Training, International Thermonuclear Experimental Reactor (ITER)/Fusion for Energy (F4E) (Fusion for Energy), Digital Europe, Erasmus+ and EU4Health.