Medical device regulation: 2026 prospects

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, setting 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.