ARTICLE SUMMARY:
Discussions between industry and the UK MHRA on the future designs of medtech regulation are accelerating, with both sides eyeing opportunities for innovation. While the post-Brexit UK is likely to hew to many elements of the EU system, there is opportunity to be more flexible and globally aware in its approach. The new system must build on the recently approved Medicines and Medical Devices Act, prioritizing the UK R&D ecosystem alongside the goals of safe and available devices.
The UK is on its own, and device regulators are engaging intensely with industry to figure out what’s next for device oversight in the country that no longer needs to abide the EU system.
“We had a meeting this morning with MHRA [the UK Medicines and Healthcare products Regulatory Agency] to talk about what should the clinical evidence requirements be for the new legislation, for example,” Steve Lee, the director of diagnostics regulation at the UK industry association ABHI and a former MHRA official, said in recent interview. “We've had meeting after meeting and are providing paper after paper for them.”
