Brazil Medical Device Regulator Delivers on Commitment to Publish Legislative Updates

By Luiz Levy, Priscila Sanada and Evangeline Loh

Background on essential safety and performance requirements

Resolution RDC 751/2022, Annex II, Chapter 3 requires that medical devices in Brazil comply with the Essential Security and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho). When the Resolution was released, this was to RDC 546/2021. This is typically documented with a completed Essential Safety and Performance Requirements Checklist, analogous to the General and Safety Performance Requirements of the European Regulations, Annex I checklists.

On the same day that RDC 751/2022 was released, Public Consultation No. 1112/2022 was also proposed to update the Essential Safety and Performance Requirements.

One of the 2024-2025 priorities for the Brazil regulator, ANVISA, was to review the Essential Safety and Performance Requirements. ANVISA announced this update at the first Board of Directors meeting on February 21, 2024.

Resolution RDC 848/2024 adds IVDs and definitions

RDC No. 848/2024 (6 March) was published to update the Essential Safety and Performance Requirements and revoke RDC No. 546/2021. The Resolution comes into force in 180 days.

Of importance to IVD manufacturers, the scope of the resolution is expanded to add IVDs (in addition to RDC 830/2023). Up until now, manufacturers of IVDs have not had to document compliance with explicit essential safety and performance requirements. Chapter II, Section IV, is specific to IVDs only.

In addition to a new Chapter I, Section III for a definition of terms, the Essential Safety and Performance Requirements are emphasized as pivotal throughout the life cycle of the device or IVD. The Essential Safety and Performance Requirements are also now harmonized with the International Medical Device Regulator Forum (IMDRF) guidance, IMDRF/GRRP WG/N47FINAL: 2018 - Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.

Resolution RDC 848/2024 requirements for software, laypeople and implantable medical devices

RDC incorporates additional Essential Safety and Performance requirements to the following:

• Software as Medical Device (SaMD) and devices that incorporate software (Chapter II, Section II, Subsection VIII);
• Risks associated with devices intended to be used by laypeople (Chapter II, Section II, Subsection XII); and,
• Implantable medical devices (Chapter II, Section III, Subsection III).

Concluding remarks

Resolution RDC 848/2024 imposes Essential Safety and Performance Requirements to IVDs as well now. In addition, as ANVISA has harmonized RDC 751/2022 and RDC 830/2023 the medical device and IVD registration legislation respectively with the IMDRF, RDC 848/2024 also further aligns with the IMDRF guidance.  This is now an important consideration for IVD manufacturers and part of the technical documentation file submitted to ANVISA for IVDs of Class II,  III and Class IV IVDs.

RDC 848/2024 becomes mandatory in 180 days. Medical device and IVD manufacturers must assess the additional requirements to ensure their medical devices and IVDs comply and that their Essential Safety and Performance Requirement checklists are updated.