The new European MDR and IVDR require that all devices are re-qualified – no grandfathering here. So how much clinical data is enough for established devices? European guidance is in the works. It’s time to speak to your Notified Body.
Over the past several months, we’ve been discussing at a high level, the upcoming changes for manufacturers considering the introduction of the Medical Device Regulations (MDR), along with the implementation of the ISO 13485:2016 and MDSAP. In this article, we’ll discuss more specifically section 8.2.2 Complaint Handling requirements under the 2016 revision of the standard which has a 3 year transition.