Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.

You must report adverse incidents with your medical device to the competent authority where the incident happened.

See the European Commission’s detailed guidance on what, how and when to report an adverse incident to MHRA.

You should also check our guidance below on what to report for certain types of devices.

Documents

  1. Reporting adverse incidents: biological and mechanical surgical heart valves

    • 26 January 2015
    • Guidance
  2. Reporting adverse incidents: coronary stents

    • 26 January 2015
    • Guidance
  3. Reporting adverse incidents: intraocular lenses

    • 26 January 2015
    • Guidance
  4. Reporting adverse incidents: breast implants

    • 26 January 2015
    • Guidance
  5. Reporting adverse incidents: inferior vena cava filter (IVC)

    • 26 January 2015
    • Guidance
  6. Reporting adverse incidents: joint replacement implants

    • 26 January 2015
    • Guidance
  7. Reporting adverse incidents: neurostimulators

    • 26 January 2015
    • Guidance
  8. Adverse incidents: cardiac ablation catheters

    • 26 January 2015
    • Guidance
  9. Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

    • 26 January 2015
    • Guidance

 

Posted on the UK MHRA website on 26 January 2015