Medicines and Medical Devices Bill introduced in UK

A new UK government bill has outlined new regulations for medical devices, such as pacemakers, breast implants and ultrasound imagers, to ensure patient safety. Named the Medicines and Medical Devices Bill, it also introduces safety measures, increases the professions that can prescribe low-risk medicines and allows hospitals to develop personalised medicines. 

Effective from 13 February, the bill enables the government to ensure medical devices are subject to high standards of regulation, boosting patient safety and ensuring the UK is able to develop pioneering health technology. With a faster, more flexible system in place, regulators will be able to respond to changes in technology or patient safety concerns as soon as possible, says a statement from the government. 

Companies will need to register medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring suppliers follow strict safety checks and enabling tough enforcement action if any undesired effects occur. 

The Health and Social Care Secretary will be given the power to disclose specific information about devices to members of the public and the healthcare system, subject to appropriate safeguards, when there are serious patient safety concerns.

Health Minister Baroness Nicola Blackwood said: “I am determined to help everyone who uses our world-leading National Health Service (NHS) to access pioneering, cutting-edge treatments as soon as possible. The new bill will give our most treasured institution further freedom to innovate to improve the lives of countless people and protect patient safety to the highest standards. It will slash red tape, support uptake of treatments for people with rare diseases and empower those in the NHS who know what’s best for their patients to deliver the best quality care.”

The new bill also means hospitals can use patient tissue and DNA samples to tailor treatments to individual patients when other medicines have failed, or to develop drugs that have a shelf-life of minutes and would otherwise be unavailable to them. This has the potential to streamline access to treatments for patients with rare cancers and brain tumours.