Written question asked by Roger Gale (Conservative) on Tuesday, 13 December 2005, in the House of Commons. It was due for an answer on Monday, 19 December 2005. It was answered by Jane Kennedy (Labour) on Monday, 19 December 2005 on behalf of the Department of Health.

Hepatitis C

Question: To ask the Secretary of State for Health when she expects that home tests for hepatitis C will receive CE registration and be available for sale over the counter in England.

Answer: Since December 2003, in vitro diagnostic devices placed on the United Kingdom market have to conform to the requirements of the In Vitro Diagnostic Devices Directive (98/79/EEC) which has been transposed into UK law by the Medical Devices Regulations 2002 (SI2002 No.618).In vitro diagnostic test kits for hepatitis C attract the highest level of control and need to have their compliance with the directive assessed by an independent certification body known as a Notified Body. The manufacturer also needs to register with the regulatory authority in the member state where the device is to be placed on the market.In so far as can be determined, no such registrations have been made for this type of test kit with the Medicines and Healthcare products Regulatory Agency in the UK, and we are not aware of any hepatitis C home test kits that are in development.

Secondary information