Incident reporting under Regulation (EU) 2017/745 is a direct patient safety requirement — one that demands accuracy, traceability, and timely action.
The Vigilance Data template provides manufacturers with a framework for recording, analysing, and documenting incidents, adverse events, and complaint data registered on various databases such as EUDAMED, MAUDE, MedSun, MHRA, ANVISA, Health Canada, PMDA, DAEN, DRAC, ANSM, BfArM, etc., during device use. It ensures all reportable events are captured in a clear, traceable manner, supporting timely identification of safety concerns and enabling informed decisions on corrective action.
Aligned with Articles 87-90 of Regulation (EU) 2017/745, MEDDEV 2.12-1 Rev. 8, and MDCG 2023-3, this template integrates directly with post-market surveillance activities, ensuring vigilance data feeds into trend analysis, risk management reviews, and benefit-risk re-assessments consistently.
Designed by experienced regulatory professionals, this template ensures no incident goes undocumented and no reporting obligation goes unmet.
Price: $100
