Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to ensure a level playing field for UK-based optometry practices and regulated optical business that provide compliant contact lens sales, in the light of unregulated overseas websites selling lenses in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medical devices placed on the market and put into service in the United Kingdom meet these regulatory requirements by:

- assessing all allegations of non-compliance brought to us, using a risk-based system;

- monitoring the activity of the UK approved bodies we designated 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 a product to be breaching the medical devices regulations, typically, the MHRA’s Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, The UK Responsible Person, outlining our 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 can be accessed on the GOV.UK website, in an online only format.

In addition to our investigatory and enforcement activities, the MHRA maintains ongoing relationships with external stakeholders, including other Government enforcement agencies and 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.