A panel of experts recently gave evidence to a Health Select Committee at the first meeting of an inquiry into device regulation in the UK and Europe. The Committee had invited written submissions on the terms of reference which were as follows:
1. Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?
2. How effectively does the MHRA implement the Directive in the UK?
3. How could the legislation and regulations be improved?
4. How could the European Commission ensure that potential changes to the Medical Devices Directive do not hinder the introduction of innovations in medical implants to the market?
At the Science and Technology Committee meeting held on 23rd May 2012, oral evidence was presented by the following witnesses:
- Dr Carl Heneghan, GP and Reader in Evidence-Based Medicine, Director of the Centre of Evidence-Based Medicine, Oxford
- Dr Thomas Joyce, Reader in Biotribology, University of Newcastle
- Professor Stephen Westaby, Surgeon, John Radcliffe Hospital
- Dr Suzette Woodward, Director of Patient Safety, National Patient Safety Agency (NPSA)
The European Directive on medical devices will be revised later this year with draft proposals expected to be published by July 2012. The European Commission has said that it will use this opportunity to strengthen existing legislation, particularly provisions relating to market surveillance, vigilance and the functioning of notified bodies. The Committee aims to influence this process.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.
To read Deborah Cohen’s summary of the Committee’s first evidence giving session, visit the following BMJ blog: http://blogs.bmj.com/bmj/2012/05/24/deborah-cohen-parliamentary-select-committee-on-the-regulation-of-implants/
To watch the video recording of the meeting, click on link : http://www.parliamentlive.tv/Main/Player.aspx?meetingId=10850 (please note it will take a minute before you hear any sound)
To read the written transcript of the meeting, click on link: http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/uc163-i/uc16301.htm