Science and Technology Committee Inquiry

(Limited Text - Ministerial Extracts only)

Tuesday 18th December 2012 Written Statements

[The Minister of State, Department of Health (Norman Lamb)]

My hon. Friend the Under-Secretary of State, Department of Health, Earl Howe, has made the following written ministerial statement:

The Government have today laid before Parliament their response to the House of Commons Science and Technology Committee inquiry into the regulation of medical implants in the UK and the EU (Cm 8496).

The Government welcome the Committee’s report and its focus on the importance of increasing transparency and accountability in the regulation of medical implants. The Government agree with the Committee on:

strengthening transparency;

improving the consistent quality of notified bodies across the EU;

increasing access to scientific expertise;

limiting the burden on small and medium-sized enterprises;

building on the current regulatory system;

introducing stricter rules on when manufacturers can rely on clinical data which is sourced from studies on a similar device; and

improving the environment for clinical investigations.

The Government are committed to further considering the Committee’s recommendations on requiring health care professionals to report serious adverse incidents and introducing a “Black Triangle Scheme”, which currently exists as a voluntary scheme for medicines, to medical devices. The Government will continue to consult with the National Joint Registry for England and Wales (NJR) on the Committee’s recommendation to publish raw data from the NJR.

As regards the Committee’s criticism that the Medicines and Healthcare products Regulatory Agency (MHRA) reacted too slowly to Australian data on the safety problems of metal-on-metal hips, the Government would like to reiterate that the MHRA was the first regulatory authority in the world to issue advice on monitoring and patient management in April 2010. The analysis of data from the National Joint Registry for England and Wales was key to the worldwide action to recall the particular metal-on-metal hip system in August 2010.