This document aims at explaining and clarifying questions related to Trend reporting as outlined in Article 88 of the Regulation (EU) 2017/745 on medical devices (MDR) and Article 83 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (“the Regulations”).
A common understanding related to Trend reporting is necessary for an effective and harmonised implementation of the Vigilance requirements under the MDR and IVDR.
This document is intended for use by Competent Authorities (CAs), economic operators and other relevant parties.