Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to strengthen enforcement against the illegal online sale of optical appliances, including by overseas suppliers operating in the UK market.

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 establish the statutory framework that medical devices must meet in order to comply with these standards.

Optical appliances as medical devices must comply with requirements set out in the regulatuons, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers based outside of the United Kingdom must have a UK responsible person, and all devices must be registered with the MHRA prior to being placed on the market. Manufacturers or their UK representatives must also monitor use of these devices when used in the UK and report serious incidents to the MHRA.

The MHRA ensure that medical devices placed on the market and put into service in the UK meet these regulatory requirements by: assessing all allegations of non-compliance brought to us, using a risk-based system; monitoring the activity of UK approved bodies we designate to assess the compliance of manufacturers; and investigating medical devices as a result of adverse incident reports or intelligence indicating a potential problem.

If the MHRA considers that a product is breaching the medical devices regulations, typically, the MHRA Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, the UK Responsible Person, outlining the agency’s concerns and requesting further information with a view to bringing them into compliance.

If a manufacturer fails to co-operate with our requests and continues to place a non-compliant product on the market, or there is a serious risk to public health, the MHRA may consider using our enforcement powers. Guidance on how we enforce medical device regulations is available at the following link:

https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices

In addition to our investigatory and enforcement activities, the MHRA maintain ongoing relationships with external stakeholders including major online selling platforms to address non-compliant listings of medical devices available on the UK market, including those listed on overseas websites. This collaboration typically involves reporting mechanisms and proactive engagement with external online platforms to identify, address and prevent non-compliant listings.