UK MHRA Medical Devices (Amendment) Regulations 2026

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published proposed changes to the pre-market regulatory requirements for medical devices and in vitro diagnostic devices in Great Britain. The proposals are set out in the draft Medical Devices (Amendment) Regulations 2026, which have been published on the World Trade Organisation (WTO) notification portal under the procedures of the Committee on Technical Barriers to Trade.

One of the proposals describes a reliance mechanism with a streamlined process for medical device manufacturers holding TGA conformity assessment certification to enter the Great Britain market. The proposal has no impact on the Australian regulatory framework.

Australian organisations may wish to submit comments to the WTO Committee on the proposed changes, including their views on the benefits or impacts of the proposal. The TGA is keen for Australian industry input, and has discussed the proposal with the MHRA directly, but this ultimately remains a matter for the UK Parliament. Details are available on the WTO website at the link above. If you have comments or views on the proposal, please let us know by 3 July 2026 so we can incorporate it into a coordinated MTAA response.