Today, medical devices play a fundamental role in healthcare. Under Article 4 of Resolution RDC No. 751, a medical device is defined as any product, such as an instrument, equipment, implant, software, or material, developed for use in humans for specific medical purposes. It may be used to diagnose, prevent, monitor, or treat diseases; treat injuries; replace or modify bodily functions; support life; assist with conception; or provide information through in vitro examinations. This definition encompasses everything from noninvasive monitoring devices to highly complex implants.
In this context, demonstrating the safety and clinical performance of these products is essential both for their registration and for maintaining them on the market, as well as for changes to their design, indication, or target population. Whenever appropriate or necessary, these data are reviewed to demonstrate that the device maintains its safety and performance without the need to conduct a clinical investigation, which involves human participants to generate such results and is therefore a more complex, lengthy, and costly process.
Clinical evaluation thus provides a structured process for gathering and analyzing relevant clinical evidence derived from the device itself or equivalent devices. According to the classification established by the Brazilian Health Regulatory Agency (ANVISA), medical devices are categorized into risk Classes I, II, III, and IV, based on the potential risks associated with their use, considering factors such as degree of invasiveness, duration of contact with the body, and intended purpose. The higher the risk class, the more rigorous the clinical evidence requirements tend to be. To obtain regulatory clearance or registration from ANVISA under RDC No. 751, clinical requirements related to safety and performance must be met. These requirements are assessed based on the following aspects:
Safety: Analysis of adverse events, identification of device-related risks, and assessment of patient exposure to demonstrate a favorable benefit-risk ratio.
Performance: Verification that the device achieves the clinical outcome consistent with its intended purpose, with consistent results and demonstrated clinical significance.
As noted above, this evidence may come from two different approaches:
Data from the device itself: These include clinical investigations, post-market clinical follow-up (PMCF) studies, patient registries, real-world use data, scientific publications about the product, and post-market information such as complaints, adverse events, and field actions. Because these data directly reflect the product, its intended purpose, and its target population, they eliminate the need to demonstrate equivalence or rely on third-party information, making this the most direct approach. To support conclusions, the methodological quality, representativeness, and clinical relevance of the data must be assessed to determine whether they are sufficient to demonstrate safety, performance, and a favorable benefit-risk ratio. As these data accumulate throughout the product's commercial life, they should be updated periodically to ensure the conclusions remain supported by current evidence.
Equivalence strategy: This approach uses data from an equivalent device, meaning a product with an active registration and clinical, technical, and biological characteristics comparable to those of the device being evaluated. The clinical data for that product may therefore be used to support the safety and performance claims of the device under review, provided they are relevant and of adequate methodological quality. Because it improves predictability and optimizes regulatory costs, equivalence is one of the most frequently adopted strategies for initial medical device registration.
In the context of registration based on equivalence, the clinical evaluation process can be divided into stages, whose results are consolidated in the Clinical Evaluation Report (CER). The main stages are:
1. Clinical context and preclinical foundation of the device: Presentation of the state of the art, tests performed by the manufacturer, and information provided in the instructions for use.
2. Clinical equivalence: Identification and assessment of a device with functions and characteristics similar to those of the device under evaluation.
3. Clinical data extraction and appraisal: Collection and critical analysis of selected literature concerning the equivalent device.
4. Technovigilance alerts: Identification of notifications, alerts, and records related to relevant devices in regulatory databases.
5. Final analysis and CER update: Integration and interpretation of the collected data, leading to conclusions about the medical device's benefit-risk profile.
Each of these stages is essential to establishing a sound evidence base. They will be presented in sequence throughout this series: clinical context and preclinical foundation (Part 2); equivalence and clinical data extraction (Part 3); technovigilance alerts (Part 4); final analysis and CER updates (Part 5); and post-market monitoring (Part 6), which continues the process after registration.
Finally, the results of this analysis must be consolidated clearly and systematically in the CER, covering the technology underlying the medical device, its intended use, and any claims related to its performance and safety. The report must also present the clinical data evaluated, specify their scope, and demonstrate how the available evidence supports its conclusions.
In light of the above, clinical evaluation is an efficient and advantageous strategy for obtaining and maintaining medical device marketing authorization. It enables safety, clinical performance, and the benefit-risk ratio to be demonstrated through scientific evidence. GRINN prepares Clinical Evaluation Reports and has extensive experience with a wide range of products registered through this process. The service is conducted in accordance with regulatory requirements and tailored to the specific needs of your product. Contact our team to learn how we can support your device registration.
References
Brazil. Brazilian Health Regulatory Agency (ANVISA). Collegiate Board Resolution (RDC) No. 751 of September 15, 2022.
Clinical Evaluation of Medical Devices, Guide No. 31/2020 ? Version 2 [Internet]. Available at: https://antigo.anvisa.gov.br/documents/10181/5736483/31V2.pdf/3ce3507c-4bc7-409d-a558-99b7be25da19
