MHRA's draft 2026 regulations would let US, Canadian and Australian approvals reach the GB market
The MHRA has published draft Medical Devices (Amendment) Regulations 2026, reforming pre-market requirements for Great Britain. The headline is an international reliance pathway allowing devices already authorised in the United States, Canada or Australia to reach the GB market without repeating a full GB conformity assessment. The regulations and the pathway arrive on different timetables: the amendment is expected to come into force in 2027, the reliance pathway itself in 2028.