Devices online services

The Devices Divisions of MHRA are committed to delivering easy to use online services that deliver efficiency improvements for users and for the MHRA.

Online reporting
We have a good track record of delivering online reporting:

  • a system for users and the public to report adverse incidents involving medical devices and equipment was introduced in September 2001
  • the MHRA launched the Manufacturers Online Reporting Environment (MORE), a more sophisticated system delivering a workspace for draft and submitted initial, follow-up and final adverse incident reports
  • the MHRA worked closely with Serious Hazards of Transfusion (SHOT) and introduced Serious Adverse Blood Reactions and Events (SABRE) online reporting in November 2005; this allows reporting to MHRA in compliance with the UK Blood Safety and Quality Regulations 2005, and simultaneous reporting to SHOT.

Online advice and guidance
Nearly all medical device publications are made available online, including Medical Device Alerts, Device Bulletins, One Liners, regulatory guidance and forms. In addition, we were an early adopter and remain a significant contributor to the electronic Safety Alert Broadcast System (SABS) introduced by the Department of Health.

Online education
Devices Clinical have produced an education programme aimed at all healthcare professionals to help them to learn more about the safe use and management of medical devices in various healthcare environments:

› Using medical devices safely

Online developments
The MHRA is a strong advocate of expanding safety related electronic communications concerning medical devices nationally and internationally.

In the UK, MHRA is working with the National Patient Safety Agency, Connecting for Health and other reporting schemes in planning for one-stop adverse event reporting. 

Internationally, MHRA is leading a drive to introduce wider electronic exchange of all types of manufacturer medical device reporting including: initial, follow-up, final; trend; periodic summary reports and field safety corrective action reports. It is also a regular contributor to and an advocate of further development of Eudamed, the European Medical Devices Database.


Page last modified: 07 February 2008