Written question asked by Lord Watson of Wyre Forest (Labour) on Thursday, 17 February 2011, in the House of Commons. It was due for an answer on Monday, 28 February 2011. It was answered by Simon Burns (Conservative) on Tuesday, 1 March 2011 on behalf of the Department of Health.

MRSA: Screening

Question: To ask the Secretary of State for Health what progress has been made on licensing for use in the NHS of the Defence Science and Technology Laboratory's product BacLite to screen against the MRSA bacterium.

Answer: Any diagnostic test of this type should be CE marked by the manufacturer according to the safety, quality and performance requirements of the In Vitro Diagnostic Devices Directive (transposed in to United Kingdom law by the Medical Devices Regulations 2002) before they are placed on the UK market. Under the directive, national regulatory authorities, who in the UK are the Medicines and Healthcare products Regulatory Agency, are not directly involved in the pre-market conformity assessment process for such tests and therefore hold no information on the product's current approval status.

Secondary information