UK’s MHRA Developing UDI System for High-Risk Devices; Pilot Planned

July 8, 2013
The UK’s Medicines and Healthcare products Regulatory Agency will pilot a unique device identifier system for implantable devices with four National Health Service trusts, as a first step to introducing UDI throughout the NHS. The tracking initiative — which aims to improve monitoring of high-risk devices like heart valves, pacemakers and breast prostheses — flows from a 2012 government report on the MHRA’s response to the PIP breast implant scandal.
Devices & Diagnostics Letter