The Brazilian Health Regulatory Agency (Anvisa) implemented RDC 848/2024, updating the essential safety and performance requirements for medical devices. This new regulation replaces RDC 546/2021 and introduces key changes, particularly the inclusion of in vitro diagnostic (IVD) devices. By aligning with global regulatory practices and technological advancements, RDC 848/2024 ensures that medical devices meet higher standards of safety and efficacy.
Key Changes in RDC 848/2024
The revised resolution reflects Anvisa’s ongoing commitment to protecting public health by ensuring that all medical devices, including IVDs, adhere to stringent safety and performance standards. Some of the essential requirements under RDC 848/2024 include:
- Purpose-Specific Design: Devices must be designed to fulfill their intended use under the conditions indicated by the manufacturer.
- Ensuring Safety: All devices should operate as intended and be safe for both users and patients.
- Functionality Assurance: Devices should perform reliably according to the manufacturer’s specifications.
- Risk-Benefit Analysis: Manufacturers must ensure that the risks associated with the device are acceptable when weighed against the benefits it provides.
- Patient Safety: Devices should not compromise the clinical condition or safety of patients during use.
These standards apply to all medical devices, including those classified as high-risk (Classes III and IV). For these devices, RDC 848/2024 mandates that safety and performance be supported by relevant clinical data. This requirement ensures that manufacturers conduct thorough evaluations using scientific evidence to verify the favorable risk-benefit ratio of these products. Furthermore, this assessment must consider the product’s entire life cycle and comprehensive risk management strategies.
A Global Approach to Medical Device Regulation
The development of RDC 848/2024 was influenced by discussions within the International Medical Devices Regulators Forum (IMDRF). This forum plays a crucial role in harmonizing medical device regulations across different countries. Anvisa’s adoption of these updated standards demonstrates Brazil’s commitment to regulatory convergence, not only with global authorities but also with regional partners such as Mercosur member countries.
By incorporating global best practices and leveraging technological advances, RDC 848/2024 marks a significant step toward improving the safety and efficacy of medical devices in Brazil. The regulation strengthens the framework for managing the risks associated with medical devices while ensuring that patient safety remains a top priority.