The Demonstration of Equivalence (DOE) template provides a structured framework for systematically establishing and documenting equivalence between a subject device and a marketed Equivalent device.
Aligned with Article 61 and Annex XIV of Regulation (EU) 2017/745 and MDCG 2020-5, the assessment covers three defined characteristics — technical, biological, and clinical. For each, similarities and differences between both devices are identified, documented, and scientifically justified. Where differences exist, their impact on safety and performance is evaluated to determine whether equivalence can still be maintained.
The DOE forms a direct input into the Clinical Evaluation Report, ensuring that equivalence conclusions are traceable and reflect the requirements of Annex I.
Built by experienced regulatory professionals, this template provides manufacturers with an equivalence assessment that meets the evidentiary standard expected by Notified Bodies.
Price: $100
