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This annual report provides an overview of medical device-related adverse incident reports received by the MHRA in 2009, 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 (including periodic summary reports) and a brief analysis of customer survey responses.
In 2009 the MHRA received 9,099 adverse incident reports involving medical devices, 2.1% more than in the previous year. This total also represents an increase of 37% over the 6,610 reports received ten years ago in 1999.
The following actions were taken by the MHRA as a result of investigations:
- 85 Medical Device Alerts were issued
- 107 notifications were shared with Competent Authorities in EU member states
- 522 manufacturer’s Field Safety Corrective Actions and 250 other manufacturer’s field actions were undertaken
- 323 cases requiring the provision of advice on safer device use or improved staff training were identified
- 793 manufacturer undertakings to improve designs, manufacturing processes and quality systems.
Report on Devices Adverse Incidents in 2009 
