UK Health Bill targets medical device regulatory gap

The UK government is preparing a Health Bill, announced in the king’s speech, that would give the Medicines and Healthcare products Regulatory Agency (MHRA) independent authority to approve medical devices and digital health technologies. The legislation aims to close a legal omission that currently forces the regulator to rely on international workarounds, and to secure supply continuity for NHS patients while restoring confidence for global manufacturers.

In Europe, the overlap between the EU AI Act and the Medical Device Regulations (MDR/IVDR) is creating compliance challenges for AI‑driven health technologies. Industry bodies are lobbying the European Commission to streamline the rules, while the UK is promoting an “International Reliance” pathway that would allow products approved by trusted regulators such as the US FDA to enter the UK market more quickly.

Both initiatives seek to shift health‑tech investment toward clinical‑grade, interoperable solutions and to reduce administrative burdens on clinicians, with the UK bill positioned as a key step toward a resilient, modern regulatory framework for medical devices.