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
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 already stated 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 Committee plans to examine the regulation of medical implants and invites written submissions from interested parties on any of the issues below by midday on Thursday 26 April 2012. The inquiry will not focus on cosmetic implants.
- Are current legislation and regulations on safety and efficacy of medical implants fit for purpose?
- How effectively does the MHRA implement the Directive in the UK?
- How could the legislation and regulations be improved?
- 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?
Select Committees are unable to investigate individual cases.
A copy of the submission should be sent by e-mail to [email protected] and marked "medical implants". An additional paper copy should be sent to:
Science and Technology Committee
House of Commons
London SW1P 3JA