Regulatory Focus™ > News Articles > UK’s MHRA Proposes Tracking System for High Risk Devices

UK’s MHRA Proposes Tracking System for High Risk Devices

Posted 07 June 2013 | By Louise Zornoza

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  The goal of the tracking system, one of 11 projects established by the agency in response to the Poly Implant Prothèse silicone breast implant issue, is to improve the monitoring of medical devices such as breast implants, heart valves and pacemakers.

The new tracking system proposed today will ultimately incorporate unique device identifiers (UDIs) into hospital patient electronic records and national Hospital Episode Statistics databases and analysis by the Clinical Practice Research Datalink (CPRD) will enable the MHRA to better assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert, without the need for multiple device registries.

John Wilkinson, the MHRA's Director of Medical Devices, commented that "The PIP breast implants episode is believed to be a case of deliberate fraud but it highlighted areas where medical devices regulation need strengthening in the UK and in Europe."

"The new tracking system for medical devices that we are piloting is still in the early stages of development, but we hope it will help us to improve the safety information we receive so that we can alert patients and healthcare professionals about potential safety problems faster," he added.

Many of the other projects are still in early development because of their complexity but the MHRA has made progress in several areas:

  • Adverse incident reporting: Adverse incident reporting increased by 25% in 2012;
  • New National Breast Implant Registry: The Department of Health is re-establishing a National Breast Implant Registry;
  • Review of UK and European notified bodies: Review of the competence of UK notified bodies notified bodies - who approve the safety of medical devices before they are sold - has been completed, and review of all other EU notified bodies is underway;
  • Strengthening regulation in Europe: 116 responses, largely supportive of stronger regulation, were received in response to the MHRA's public consultation on the European Commission's proposals to improve medical device regulation;
  • New European reporting portal: The MHRA took the lead in generating funding from other European countries to pilot a new portal that will improve the safety monitoring of medical devices that are used in Europe.

MHRA Notice on Medical Devices

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