Written question asked by Clive Betts (Labour), in the House of Commons. It was due for an answer on Wednesday, 19 March 1997. It was answered by Lord Horam (Conservative) on Wednesday, 19 March 1997 on behalf of the Department of Health.

Dept of Health

Question: Pursuant to his Answer of 6th March, Official Report, c739W, if he will assess the advantages of classifying silicone implants as human prostheses.

Answer: Mr. Betts: To 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. Horam: Implanted 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.

Secondary information