MEDICAL TECHNOLOGY
Medical device regulation: 2026 prospects
After a busy 2025, the next few months will see further change in the regulation of medical devices around the globe. Jonathan Ripley picks 10 trends to monitor.
The global medical technology landscape is undergoing a profound regulatory transformation as authorities shift from static pre-market approvals toward dynamic, lifecycle-based oversight. Following a pivotal 2025 defined by the EU AI Act and the FDA’s Predetermined Change Control Plans, 2026 marks a move toward ‘continuous compliance’ where AI maturity, Good Machine Learning
Practice, and mandatory cybersecurity documentation are now central to market access. This article reviews some of the main changes to monitor in 2026. 2025 was a busy year for healthcare
legislators around the globe. In the EU Regulation (EU) 2024/1860’s Mandatory Supply Interruption Notification – which requires manufacturers to notify authorities and healthcare providers
at least six months in advance if they anticipate a supply disruption that could harm patients – was introduced. Most significantly, on 16 December 2025, The European Commission published COM(2025)1023, a landmark proposal to reform MDR and IVDR around three defining principles: lifecycle surveillance oversight, a stronger emphasis on post- market data and proportionate regulation calibrated to risk. Complementing this, MDCG 2025-10 was issued just days later, seting out authoritative new guidance on post-market surveillance, reinforcing that continuous, real-world monitoring is now the cornerstone of EU device regulation. In the UK, the first major post-Brexit divergence comes with the introduction of new Post-market Surveillance Regulations on 16 June 2025. At a global level the debate around AI and Software as a Medical Device (SaMD) has intensified with the publishing of the EU AI Act and the FDA’s final guidance on Predetermined Change Control Plans (PCCP). The year ahead looks set to be intense
as proposals are debated and new guidance is rolled out across a range of topics and devices. In short, while the range of upcoming
regulatory changes is wide and diverse across the globe, international bodies are aligned on some key major issues such as managing the use of AI in medical devices, increasing patient safety and simplifying processes where possible to allow access to innovation. Although it’s difficult to distil these
into a handful of topics, here are 10 major trends to keep monitoring:
International bodies are aligned on some key major issues such as managing the use of AI in medical devices.
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WWW.PATHOLOGYINPRACTICE.COM June 2026
1. AI / ML regulation accelerates Regulatory bodies are transitioning from traditional, static pre-market approvals toward a lifecycle-based oversight model to accommodate the evolving nature of artificial intelligence (AI) and machine learning (ML). Since these technologies are designed for continuous learning and adaptation, agencies like the FDA, MHRA, and EU regulators are emphasising post-market monitoring and ‘Predetermined Change Control Plans’. This shift acknowledges that the old regulatory paradigms were not built for adaptive software, necessitating more individualised evaluations rather than a one-size-fits-all approach. While technology has reached a level of maturity, its integration into the highly regulated healthcare sector remains in its infancy, requiring a delicate balance between rapid innovation and the prevention of tangible dangers like misdiagnosis or hacked delivery systems. The global regulatory landscape is becoming increasingly complex due to
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