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This annual report provides an overview of medical device related adverse incident reports received by the MHRA in 2007, and records recent developments in adverse incident reporting. It also includes an update from the Device Technology and Safety (DTS) division’s three specialist technical units, background information on incident reporting procedures, a summary of the year’s key statistics and a brief analysis of customer survey responses.
In 2008 the MHRA received 3.1% more adverse incident reports than in the previous year. The 8,902 total for 2008 also represents an increase of over 41% over the 6,298 reports received ten years ago in 1998.
The following actions were taken as a result of investigations made:
- 88 Medical Device Alerts (MDAs) were issued
- 96 notifications were shared with Competent Authorities in EU member states
- 568 manufacturer’s Field Safety Corrective Actions and 250 other manufacturer’s field actions were undertaken
- 363 cases requiring the provision of advice on safer device use or improved staff training were identified
- 822 manufacturer undertakings to improve designs, manufacturing processes and quality systems
Report on Devices Adverse Incidents in 2008 
