New draft Guidance on Trend Reporting
The Medical Device Coordination Group (MDCG) has endorsed a new draft Q&A document on trend reporting under the EU Medical Device Regulation (MDR) and the in vitro diagnostics Regulations (IVDR) (Trend Reporting Q&A (MDCG 2025-X)).
Article 88 of the MDR and Article 83 of the IVDR provide a framework through which manufacturers should report statistically significant increases in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis.
The draft Guidance, which is in the form of Questions and Answers, complements MDCG 2024-1 on Guidance on the vigilance system for CE-marked devices. It discusses, among other things, how manufacturers should assess what constitutes “a significant impact on the benefit-risk analysis”.
The draft provides that, within the context of trending, a “significant increase” should be determined by comparing the foreseeable frequency and/or severity of the incidents with the statistical methodology set out in the technical documentation. The draft includes practical advice on what documentation should accompany trend reporting and how trend reporting is linked to the manufacturer’s Post Market Surveillancec plan and its QMS.
The draft Guidance has been released for stakeholder review. It is not yet clear when the final version of the Guidance will be agreed.