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Brazilian Essential Safety and Performance Requirements for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices: Resolution RDC No. 848, 2024

This blog was originally posted on 15th April, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY FERNANDA PARO, REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

On 8 March 2024, the Brazil National Institute of Metrology, Standardization and Industrial Quality (INMETRO/CONMETRO) published Resolution RDC No. 848, which outlines the essential safety and performance requirements for medical devices and in vitro diagnostic devices (IVD). This resolution revises the existing Resolution RDC No. 546/2021 on Technical Regulation of Essential Requirements for Medical Devices.

In this blog, we examine the finer details of Resolution RDC No. 848.

Overview of Resolution RDC No. 848

Resolution RDC No. 848 aims to align the regulations with advancements in the medical device sector. The revised criteria are designed to enhance Anvisa’s technical evaluation, addressing the complexities introduced by new technologies and the wide range of devices. A significant advantage of this update is the improved guidance for manufacturers, who will receive explicit instructions on the necessary studies and evidence for product registration, thereby strengthening the quality of the documentation provided.

Resolution RDC No. 848 has been ratified and will come into force on 4 September 2024, when all medical devices and in vitro diagnostic (IVD) medical devices shall adhere to the universal standards of safety and performance during the design and manufacturing stages. The Essential Safety and Performance Requirements are now also 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.

Certain principles and conditions are required and must be observed throughout the entire life cycle of these devices, but exceptions to these principles are permissible for specific devices, provided that a valid justification for their exclusion is presented.

Requirements of Resolution RDC No. 848

The fundamental design and manufacturing requirements are highlighted to ensure the safety and effectiveness of these devices. The following criteria should be respected:

Achieve the performance anticipated by the manufacturer;
Be designed and manufactured to be fit for the intended use under prescribed usage conditions;
Remain safe and operational as intended;
Present acceptable risks when weighed against the benefits for the patient;
Not jeopardize the clinical condition or safety of patients or others.

Manufacturers are required to develop and uphold a risk management system that guarantees the continuous quality, safety, and performance of medical devices and IVDs, adhering to detailed guidelines. They must also communicate significant residual risks to users and implement measures to mitigate these risks. All devices must be engineered, produced, and packaged to preserve their integrity, cleanliness, and sterility.

Resolution RDC No. 848 mandates thorough clinical evaluations to confirm the intended purpose, performance, and safety of the devices based on clinical data that supports a favorable risk-benefit assessment. It addresses the environmental impact and the integration of software in medical devices. Devices that incorporate software must comply with the highest standards of accuracy, reliability, and safety, reflective of the latest technological advancements, and include robust cybersecurity protections.

Moreover, Resolution RDC No. 848 stipulates that all devices must be accompanied by essential information regarding their identification, safety, and performance, ensuring that this information is both accessible and understandable to users. Devices shall be designed to minimize radiation exposure in a manner that aligns with their medical purposes, thereby ensuring safety without unnecessarily limiting their use.

Conclusion

Overall, Resolution RDC No. 848 provides comprehensive regulations for medical devices and in vitro diagnostics (IVDs), addressing aspects such as safety, performance, risk management, and environmental considerations, all aimed at enhancing the standards of medical technology.

In addition to updating the essential safety and performance requirements, Resolution No. 848 integrates the Mercosur Technical Regulation into the national legal framework, replacing Resolution GMC 72/98.

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