Written question asked by Clive Betts (Labour), in the House of Commons. It was due for an answer on Thursday, 6 March 1997. It was answered by Lord Horam (Conservative) on Thursday, 6 March 1997 on behalf of the Department of Health.

Dept of Health

Question: What clinical trials are (a) commissioned and (b) evaluated on human prostheses, prior to their being made available through the National Health Service. - Inc fact that manufacturers who wish to run clinical trials on medical devices must submit their protocol to the Medical Devices Agency for assessment prior to the commencement of the trial.

Answer: Mr. Betts: To ask the Secretary of State for Health what clinical trials are (a) commissioned and (b) evaluated on human prostheses, prior to their being made available through the national health service. [18827] Mr. Horam: Under the medical devices regulations which came into force on 1 January 1995, manufacturers who wish to run clinical trials on medical devices must submit their protocol to the Medical Devices Agency for assessment prior to the commencement of the trial. Since that date, there have been 20 applications for trials on human prostheses. As part of the marketing approval system under the regulations, designated independent certification organisations may assess the results of such trials as part of the conformity process prior to the product being placed on the market and being available for use in the national health service or more generally.

Secondary information