House of Commons - Regulation of medical implants in the EU and UK

Science and Technology Committee - Fifth Report
Regulation of medical implants in the EU and UK

Here you can browse the report together with the Proceedings of the Committee. The published report was ordered by the House of Commons to be printed 17 October 2012.

Contents

Regulation of medical implants

The MHRA

High profile medical device recalls

PIP breast implants

Metal-on-metal hip implants

3 Pre-market approval

Clinical data requirements

Cost and timescale of clinical trials

Transparency of evidence

Comparisons with the FDA

Notified bodies across Europe

4 Post-market surveillance

Reporting of adverse incidents

Manufacturers

Clinicians and patients

Registries

EU registry

Responding to adverse incidents

Auditing manufacturers

5 Conclusions

The MHRA

The regulation of medical implants

Conclusions and recommendations

Formal Minutes

Witnesses

List of printed written evidence

List of additional written evidence

List of Reports from the Committee during the current Parliament

Oral and Written Evidence

23 May 2012

13 June 2012

Written Evidence

Additional Written Evidence