Time to get serious on postmarket 28 June 2019
For years regulators have talked about the importance of continuous monitoring and follow up of approved devices – so called Postmarket Regulation, or Vigilance in Euro-speak.
But frankly, industry focus and regulator resources have always been weighted towards up-front review – premarket evaluation.
That’s all changing. The European MDR includes explicit and comprehensive requirements for postmarket follow up and reporting – and a shiny new database to contain all that information. Australia’s TGA is consulting on a range of new postmarket initiatives and the US FDA recently moved to abandon summary reporting of adverse events, mandating public, case by case reporting of incidents associated with devices such as breast implants.
Join Arthur Brandwood and TJ Thiel to hear why it’s time to get real on Postmarket. And how to manage your devices through the whole lifecycle.