Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they plan to update medical device regulations to bring UK-based online contact lens retailers under a clear regulatory framework; and whether they plan to introduce measures including (1) a recognised compliance mark, (2) stronger border controls, and (3) oversight to ensure customers identify lawful suppliers and reduce the risk of eye infections.

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.

Opthalmic 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 use of these devices when used in the UK. Allegations of deficiencies that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance, with further information available on the GOV.UK website.

The MHRA is not responsible for the movement of medical devices across borders.