Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of introducing regulatory standards for the marketing of consumer DNA testing kits.

The Medicines and Healthcare products Regulatory Agency is aware that there are a number of DNA test kits on the market. The majority claim to provide information on ancestry, and in general these would not be regarded as medical devices.

However, those that make medical claims in relation to predisposition of medical conditions would be regarded as in vitro diagnostic medical devices and would require the relevant CE mark or a UK Conformity Assessed marking.