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Dept of Health

Answer

Tim Loughton: To ask the Secretary of State for Health what action he has taken with the Medical Devices Agency to improve public confidence in the effectiveness and reliability of self-testing diagnostic medical devices. [88529] Mr. Lammy: The United Kingdom was one of a small number of European Community member states that transposed the in vitro diagnostic (IVD) directive into national law by the required deadline (June 2000). All IVD manufacturers placing products on the European market will be required to meet this legislation by December 2003. Public confidence in the reliability and effectiveness of self-testing diagnostic medical devices will be improved when the IVD regulations come fully into force, and evidence is provided by the manufacturers that the results provided are accurate and meaningful. In order to learn about concerns that the public might have with medical devices, the Medical Devices Agency introduced, in September 2001, "on-line" reporting for members of the public for all medical devices, including in vitro diagnostic medical devices. In addition, the Department has published two voluntary codes of practice and guidance for genetic tests being sold directly to the public. These set out broad requirements in areas such as peer-reviewed evidence of value, accreditation and quality assurance in testing laboratories, consent, confidentiality, sample and information storage, and customer information.

Secondary information

Type

Written question

Reference

88529; 397 c197W

Session

2002-03

Subjects

Diagnosis Medical equipment Standards Testing Medical Devices Agency

Link

View this Written question on www.publications.parliament.uk