Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have to (1) extend regulatory powers, (2) improve reporting mechanisms, and (3) work with (a) online platforms, (b) manufacturers, (c) professional bodies, and (d) enforcement agencies, to address the illegal online sale of optical appliances.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) establish the statutory framework that medical devices must meet in order to comply with these standards.

Optical appliances as medical devices must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their UK representatives must also monitor the use of these devices when used in the UK and report serious incidents to the MHRA. Allegations of deficiencies and incidents that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance around enforcement and compliance.