The Medicines and Healthcare products Regulatory Agency has published new pre-market regulatory requirements for medical devices and in vitro diagnostic devices.
New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the British market have been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
The notification provides an opportunity for World Trade Organization (WTO) members to comment on the draft pre-market regulatory requirements, titled the draft Medical Devices (Amendment) Regulations 2026. The medtech industry, approved bodies, healthcare providers and patients are also invited to share their views on the impact of the proposed changes via an MHRA survey.
Responses will inform the Impact Assessment and future implementation of the regulations.
The draft regulations are designed to give faster access to safe and innovative medical devices and support economic growth and innovation in the medtech sector, and introduce a framework to enable swifter access for devices already approved by regulators in Australia, Canada and the US.
They will require healthcare organisations that implant medical devices to give patients implant cards that provide information about the device that was implanted, improving the ability to manage adverse events, and transparency for patients. Unique device identifiers (UDI) will also be made compulsory to enable precise identification and traceability of devices throughout their lifecycle.
They will also align classifications of in vitro diagnostic (IVD) devices with those of the International Medical Device Regulators Forum (IMDRF) standards, and align the essential requirements for medical devices in Great Britain with best international practice.
As Healthcare Today reported, in July last year, the government said that it intends to amend medical devices regulations to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices.
