The issues raised by personal genome testing kits were considered by the Human Genetics Commission’s 2010 publication on the Common Framework of Principles for Direct to Consumer Testing Services. These principles were endorsed by the Department of Health as providing advice to companies who were considering marketing such services to United Kingdom customers.
Products used in direct-to-consumer testing services providing health-related information are regulated as in vitro diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK competent authority for medical devices. The MHRA does not have a role in assessing in vitro diagnostic medical devices before they come onto the market.
The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.