UK MHRA Draft Medical Device Regulations 2026: Key Changes and Timeline

Medical Device Global Market Access · Jul 17, 2026 · 5m

This episode covers the closing of the WTO comment period on July 7, 2026, for the UK MHRA's draft Medical Devices (Amendment) Regulations 2026. We break down the key changes manufacturers need to prepare for, including the new international reliance pathway for approvals from other major regulators, the implementation of a UK-specific Unique Device Identification (UDI) system, and the significant shift to a risk-based classification system for In-Vitro Diagnostics (IVDs). We also discuss the expected timeline for these regulations to become law in late 2026 and provide practical steps for…