§ Mr. BettsTo ask the Secretary of State for Health, pursuant to his answer of 6 March,Official Report, column 739, if he will assess the advantages of classifying silicone implants as human prostheses. [20978]
§ Mr. HoramImplanted human prostheses, such as breast implants, come within the scope of the Medical Devices Regulations (SI 1994 No 3017). Under the regulations medical devices fall into four different risk categories which dictate the severity of controls that are applied before the device may be sold; implanted human prostheses such as silicone implants fall into the second highest category. This means that before a manufacturer can place his device on the market with a "Conformity European" marking of conformity under the regulations he must have his design and manufacturing process verified by an independent certification organisation to ensure that the devices produced meet the relevant essential requirements relating to safety, quality and performance.