New draft Guidance on Trend Reporting
Medical Devices, In Vitro Diagnostic Regulation, Trend Reporting Elisabethann Wright Medical Devices, In Vitro Diagnostic Regulation, Trend Reporting Elisabethann Wright

New draft Guidance on Trend Reporting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

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