HC Deb 20 December 1999 vol 341 c421W
Mr. Oaten

To ask the Secretary of State for Health what plans he has to ensure that local government social services departments establish traceability systems for medical devices registered for CE marking. [R] [103094]

Mr. Hutton

All medical devices when first placed on the market have to be CE marked by the manufacturer or supplier to demonstrate they are safe to use and conform with the requirements of the Medical Devices Regulations. These Regulations are enforced by the Medical Devices Agency (MDA). The MDA distributed the good practice guide "Medical Device and Equipment Management for Hospital and Community-based Organisations" to the National Health Service and social services in January 1998. This included guidance on record-keeping for good equipment management, including the tracing of products. This guidance was referred to in the later publication "Good Practice in Disability Equipment Services", which was commissioned by the Department from the Disabled Living Centres Council and distributed to the NHS and to social services in October 1998.

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