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Regulation of Medical Devices

Volume 545: debated on Monday 14 May 2012

My noble Friend the Under-Secretary of State for Health (Earl Howe) has made the following written ministerial statement.

I am today publishing two documents relating to the regulation of medical devices and other cosmetic interventions and stemming from the fraudulent use of non-medical grade silicone in the breast implants manufactured by the French company Poly Implant Prothèse (PIP).

The first document is my review of the actions of the MHRA and Department of Health in relation to PIP implants, announced by the Secretary of State for Health on 11 January. The review finds that there is room for improvement in the operation of the MHRA and the regulation of medical devices. However, it also finds that the regulator acted reasonably, and that, in taking difficult decisions on how to communicate the problems with PIP implants to the public, it followed clinical and scientific advice.

The review also found that the MHRA should identify ways of gathering better evidence on the safety of devices, broaden its approach to analysing reported problems with higher-risk medical devices and find better ways of communicating with the public. The operation of the European regulatory system must improve and health professionals and providers also need to be better at reporting problems when they occur.

The second document is “The Government’s Response to the House of Commons Health Committee: Sixteenth Report of session 2010-12” Cm 8351. In this response, we welcome the Committee’s analysis of the problems relating to PIP implants and their many helpful suggestions. Some of these are already reflected in the report mentioned above. Other recommendations will be picked up in the further work of Sir Bruce Keogh’s expert group on PIP implants, and in the separate review into the regulation of cosmetic interventions, also announced on 11 January. A further announcement about the review will be made in the near future.