Post-Brexit UK to Overhaul Medical Device Authority
The UK government has introduced a bill that would update the nation’s regulatory framework for medical devices by the end of the post-Brexit transition period which ends Dec. 31, 2020.
The bill is intended to “introduce new regulations on medical devices, such as pacemakers, breast implants, and ultrasound images, to ensure patients safety,” the Department of Health and Social Care said.
The department will have the authority to release specific information about devices to members of the public and the healthcare community if there are serious patient safety concerns. But the new authority will still be subject to data protection legislation and to provisions that restrict the disclosure of commercially sensitive information.
The new legislation would also empower the department to impose monetary penalties as an alternative to criminal prosecution for those who breach the Medical Devices Regulations 2002.