Essential Requirements & Performance (ABNT/ISO Standards)
RDC 751/2022 Annex II defines the Essential Requirements (Requisitos Essenciais) all medical devices must meet. Categories: general requirements (safe and performing as intended), design and construction, labelling and IFU, active devices (electrical safety, EMC, software), devices with measurement function, implantable devices, and radiation-emitting devices.
Compliance is demonstrated by reference to harmonised ABNT standards (creating presumption of conformity), international standards (ISO, IEC, ASTM), or test data. The dossier must include a completed Essential Requirements Checklist mapping each requirement to evidence.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.