The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety.
The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by Brexit, which removed the U.K. from the European Union’s drug and medical device regulatory authorities.
The power to make medical device regulations goes to the secretary of state for Health and Social Care, who will set the rules for medical device safety, availability, research, development and manufacturing as well as making the U.K. attractive to medtech production.
The new law also sets up regulations governing medtech developers’ fees, device safety and performance record-keeping, device suspensions and recalls, and legal ramifications for failure to comply with safety and efficacy requirements.
The heightened focus on patient safety and communications stemmed from public input to a safety review board, which determined that women’s concerns, in particular regarding pelvic mesh and drug-related birth defects, had been disregarded in the past.
You can read the law here.