In September 2024, the Resolution of the Collegiate Board (RDC) No. 848, published by ANVISA, will come into effect, bringing new requirements for the registration, monitoring, and safety and performance evaluation of medical devices in Brazil. This new regulation aims to ensure that these products comply with safety and efficacy standards, protecting the health of patients and healthcare professionals. In today’s article, we will explore the implications of this resolution and how it affects the evaluation of medical devices.
RDC 848/2024: A New Regulatory Approach
The primary objective of RDC 848/2024 is to establish stricter and more detailed criteria to ensure that medical devices marketed in Brazil are safe and effective. The resolution aligns Brazil with international regulatory standards, such as those established by the European Union and the United States (FDA), ensuring that medical devices used within the national territory undergo rigorous evaluation processes. Among the changes brought by the RDC, the following points stand out:
Strengthening Safety Evaluation: The resolution reinforces the obligation of a thorough risk analysis, following the parameters of the ISO 14971 standard. Manufacturers must identify, assess, and mitigate all potential risks associated with the use of the medical device, with an emphasis on minimizing hazards for patients, healthcare professionals, and third parties.
Detailed Documentation: The new regulation requires the development of more robust technical reports, documenting all tests performed, results, and risk mitigation measures implemented. These reports will be essential for registration with ANVISA, as well as for future audits.
Clinical Validation and Performance Testing: In addition to the safety evaluation, the resolution focuses on proving the performance of medical devices. Functional tests, biocompatibility (ISO 10993), and clinical validations become mandatory for devices to meet regulatory requirements. This clinical validation must be conducted in controlled environments, with data demonstrating the device’s efficacy and safety in real-world use.
Medical Device Safety Evaluation
Safety is one of the central pillars of this resolution. The safety evaluation process involves several stages, including:
Risk Analysis: Using the ISO 14971 standard as a reference, the risk analysis is conducted to identify potential failures and hazards associated with the medical device. Each risk is assessed in terms of severity and likelihood of occurrence. Once identified, control measures must be implemented to mitigate these risks, with the effectiveness of these measures rigorously tested.
Compliance Testing: RDC 848/2024 mandates compliance with international safety standards, such as IEC 60601-1 for electromedical devices. These tests ensure that the device is safe in terms of electrical, thermal, and other exposures.
Biocompatibility Studies: RDC 848/2024 also reinforces the need for studies that prove the biocompatibility of materials used in medical devices. Following the guidelines of ISO 10993, these tests ensure that the device does not cause adverse reactions, such as toxicity or sensitization.
Medical Device Performance Evaluation
In addition to safety, performance evaluation also gains importance with RDC 848/2024. This evaluation aims to ensure that the medical device functions as expected throughout its lifecycle and meets clinical efficacy requirements. The performance evaluation involves:
Functional Testing: These tests verify whether the device performs the functions for which it was designed, even under different operating conditions. These tests also assess whether the device’s performance is maintained over time, ensuring consistency in its functionality.
Clinical Validation: Clinical validation involves studies in controlled environments, with the use of the device on patients. This process is crucial to provide direct evidence that the device is effective and safe in real-world use conditions.
Software Verification and Validation: In cases where the device includes software, the RDC requires the software to be tested according to IEC 62304 guidelines. This ensures that the software operates reliably, without compromising the safety and performance of the medical device.
Safety and Performance Evaluation Report
After completing all evaluation stages, the manufacturer must prepare an evaluation report that documents all findings, conclusions, and evidence of compliance. This report is essential for the device’s registration process with ANVISA and for meeting the regulatory requirements of RDC 848/2024.
Conclusion
RDC 848/2024 represents an important step in modernizing the control of medical devices in Brazil, requiring rigorous evaluations and complete documentation to ensure the safety and efficacy of these products. Compliance with international standards such as ISO 14971, ISO 10993, and IEC 60601-1 will be crucial to achieving and demonstrating this safety and performance.
If you work in the development or commercialization of medical devices, it is crucial to prepare for the new regulatory requirements, ensuring that your products comply with RDC 848/2024. For more details on the RDC and how it impacts the department, it is crucial that companies and professionals in the department are aware of these updates and adapt to the new requirements. Compliance with technical standards is essential to ensure approval of registration, notification, revalidation, or modification requests for equipment.
📝 Access the RDC 848/24 Normative Instruction:
- The translated version in English is available here: RDC – 848/2024
The text in the original language of this announcement is the official authorized version. The translations are provided for convenience only and should refer to the text in the original language, which is the only version of the text that has legal effect.
- Read RDC 848/2024 here: RDC 848/2024 (PT)
In case of doubts, please contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
