Description:
This MDR Vigilance instruction helps us document whether a complaint-related event is a reportable incident in Europe under Regulation (EU) 2017/745, with a clear decision trail and timelines.

• Confirm an incident as defined in the “Complaint Evaluation” step before applying vigilance criteria.

• Assess causal relationship (established, reasonably possible, or suspected) and record the justification.

• Identify serious public health threat and apply the 2 calendar days timeline.

• Evaluate potential death impact and apply 10 days (or earlier when causality is suspected).

• Evaluate serious deterioration in state of health and continue the decision tree.

• Check whether the incident was anticipated in the risk management file to select 15 days vs 10 days.

• Retain the complaint ID COMYYYY-XXX and file the record in Attachment B-X.

Your needs:

• MDR vigilance reporting

• MDR vigilance reporting for MDR decision-making

• Reduce missed timelines, improve consistency, and strengthen inspection-ready justifications.

This SOP is used whenever a complaint suggests a serious incident and we must decide EU reportability and the correct reporting timeline, while keeping the decision record attached to the complaint file.

It standardizes key terms. Causal relationship is “reasonably possible” unless absence is established; this matters because it prevents under-reporting. Serious public health threat covers alarming, unexpected risks with potential for multiple harms; this matters because it triggers a faster timeline.

• Document each decision-tree outcome and its justification.

• Apply the correct 2/10/15-day timeline based on criteria and anticipation.

• Record “not reportable” outcomes and ensure trend monitoring.

• Keep the same complaint ID and file the record in Attachment B-X.

• Align decisions to MDCG 2023-3 requirements for Europe.

At Lexqara, we help you operationalize complaint handling and MDR vigilance reporting with practical templates, training, and PMS linkage—supporting post-market surveillance and inspection readiness. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. MDCG 2023-3 guidance [https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-3_en.pdf]. Request a short gap assessment.