HC Deb 11 June 1999 vol 332 cc418-9W
Mr. Oaten

To ask the Secretary of State for Health what plans his Department has to require health authorities which produce or modify medical equipment to obtain a CE Mark registration before the equipment is issued. [86677]

Ms Jowell

Any health authority which places medical devices on the market must comply with the requirements of the Medical Devices Regulations and CE mark their product accordingly.

Mr. Oaten

To ask the Secretary of State for Health which companies or Government organisations his Department has exempted from the requirement to obtain CE Marks for medical equipment. [86676]

Ms Jowell

None. All manufacturers or other organisations who place medical devices on the United Kingdom market must go through the appropriate conformity assessment procedure detailed in the Medical Devices Regulations and CE mark their products accordingly. Health care establishments who make a device for their own use in-house are not regarded as having placed a product on the market.

Mr. Oaten

To ask the Secretary of State for Health what plans he has to make the list of medical equipment which has obtained a CE Mark available for public inspection. [86674]

Ms Jowell

As required by the Medical Devices Regulations, the Medical Devices Agency maintains a register only of manufacturers of low risk and custom-made devices and assemblers who have a place of business in the United Kingdom. Article 20 of the Medical Devices Directive prevents data on this register being made publicly available.

Mr. Oaten

To ask the Secretary of State for Health what guidance his Department has issued to health authorities about the need to obtain CE Marks for medical equipment. [86675]

Ms Jowell

In January 1998 the National Health Service Executive issued an Executive Letter (EL(98)5) to all health authorities reminding them of their responsibilities under the Medical Devices Regulations. In addition the Medical Devices Agency has produced a Guide for Health Care Professionals on the CE marking of Medical Devices together with a leaflet on the CE mark plus a Bulletin on the application of the Regulations on the activities of health care establishments. Copies of these documents are available in the Library.

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