Written question asked by John Baron (Conservative) on Monday, 23 April 2012, in the House of Commons. It was due for an answer on Thursday, 26 April 2012. It was answered by Simon Burns (Conservative) on Thursday, 26 April 2012 on behalf of the Department of Health.

NHS: Screening

Question: To ask the Secretary of State for Health with reference to the answer to Lord Walton of Detchant of 26 March 2012, Official Report, House of Lords, column 208WA, on in-vitro diagnostic tests, whether he has any plans to require health institutions to report adverse incidents with in-house pathology tests in the same manner as for commercial pathology tests.

Answer: Directive 98/79/EC on in vitro diagnostic medical devices (IVDs) includes an exemption from the provisions of the legislation for IVDs manufactured 'in-house' by health institutions. The Medicines and Healthcare products Regulatory Agency (MHRA) does not currently have any plans to extend the provisions of the directive relating to the requirement to report adverse incidents to cover IVDs manufactured 'in-house' by health institutions.However, Directive 98/79/EC is currently the subject of a revision by the European Commission and revised legislation is expected to be published in autumn 2012, for agreement through the ordinary legislative procedure. The revised legislation is expected to maintain an exemption for health institutions manufacturing IVDs 'in-house'; albeit with additional requirements for those health institutions to meet certain standards and an exclusion from the exemption for the highest risk devices. It is not yet clear whether the revised legislation may also include a requirement for adverse incidents to be reported to the MHRA by health institutions manufacturing devices 'in-house', although the MHRA will give careful consideration to the merits of such a proposal when finalising the United Kingdom negotiating position for the revision of the directive.

Secondary information