Life sciences glossary

The Life sciences glossary pulls together key definitions of life sciences terms and provides links to relevant resources. The glossary is growing as we identify further terms for inclusion. One growing area is artificial intelligence (AI) and machine learning (ML). The Life sciences glossary includes certain terms that relate to AI/ML

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Latest Life Sciences News

MDCG publishes guidance on post-market surveillance for medical devices and IVDs

The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance (MDCG 2025-10) clarifying post-market surveillance (PMS) requirements under Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The guidance emphasises that PMS should operate as a continuous and proactive process throughout a device’s lifecycle and be fully integrated into manufacturers’ quality management systems. It calls for the active collection and analysis of data, including from scientific literature, registries and the European Database on Medical Devices (EUDAMED), with findings feeding into risk management, clinical evaluation, labelling and corrective actions. Manufacturers must also maintain a device-specific or device-group PMS plan, setting out data collection methods, analysis approaches and predefined thresholds for action.

Commission publishes new MDCG guidance on post-market surveillance

The European Commission has published MDCG 2025–10, a new guidance document on post-market surveillance of medical devices and in vitro diagnostic medical devices, setting out a common approach to how manufacturers and other stakeholders should meet post-market surveillance obligations under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices across the EU.

MHRA launches call for evidence on the regulation of artificial intelligence in healthcare

The Medicines and Healthcare (MHRA) products Regulatory Agency has launched an open call for evidence to inform the work of the National Commission into the Regulation of AI in Healthcare, seeking views on how artificial intelligence used in healthcare should be regulated in the UK. The MHRA established the Commission to advise on the development of a regulatory framework for AI as a medical device that is safe, effective, proportionate and trusted, with recommendations to be published in 2026. It seeks views on whether the current regulatory framework is sufficient, how it may need to be improved to support timely access to safe and effective AI medical devices, how safety and performance should be monitored once such technologies are in use, and how responsibility and liability should be allocated across those involved in their development and deployment, in order to address emerging regulatory challenges while supporting innovation and maintaining public trust . The call for evidence will run until 2 February 2026.

MHRA updates guidance on Health Institution Exemption for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Health Institution Exemption (HIE) for general medical devices in Great Britain. The exemption allows health institutions, such as NHS Trusts and Boards to design, manufacture or modify devices for in-house use only, subject to safety and quality requirements. Key changes include clearer definitions, practical examples and five principles of good practice: (1) quality management; (2) ensuring device traceability; (3) meeting essential requirements; (4) keeping technical documentation; and (5) post-market monitoring. The exemption applies only to general medical devices and does not cover in vitro diagnostic devices (IVDs). Institutions should inform patients when devices are made under the exemption and report safety issues via the Yellow Card scheme. The update replaces previous in-house manufacturing guidance. Separate EU-aligned rules apply in Northern Ireland.