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.
Verify all information against official ANVISA sources before making regulatory decisions.
The Essential Requirements Checklist (also called the Conformity Assessment Report) must be completed for each device and included in the dossier. A template can be obtained from ANVISA or developed based on RDC 751/2022 Annex II. The checklist must show the requirement number, requirement text, applicable ABNT/ISO standards or test data, and the location of supporting evidence in the technical dossier.