The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 83 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (together referred to as “the Regulations”).
A shared understanding of Trend reporting is essential to ensure the effective and harmonised implementation of the Vigilance requirements under both the MDR and IVDR. This guidance is intended for use by Competent Authorities (CAs), economic operators, and other relevant stakeholders involved in medical device and IVD vigilance activities.
Please note that this is a draft document, and its content may be updated before final publication.
The draft guidance document can be accessed using the following link
