Complying with EU IVDR Postmarket Surveillance (PMS) Requirements
Once the IVDR takes effect, roughly 85% of all IVDs will be subject to Notified Body oversight. As such, manufacturers will be expected to compile detailed technical documentation prior to obtaining CE Marking certification or placing their device on the EU market. A critical piece of that documentation includes your plans and procedures for postmarket surveillance (PMS) – a fancy name for ensuring the ongoing safety and efficacy of your device. Despite the name and regardless of device risk, PMS […]
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