Clinical Evaluation
Clinical evaluation is a fundamental component of regulatory submissions for medical devices in Brazil. In accordance with Anvisa Guidance No. 31/2020 and international best practices, manufacturers must present a clear, evidence-based assessment of device safety and performance.
We support this process through a methodical clinical evaluation strategy—combining literature analysis, data gap assessment, and expert interpretation to produce documentation that aligns with Brazilian regulatory expectations.
How We Support Your Clinical Evaluation
A Clinical Evaluation Report (CER) is a structured analysis of clinical data, drawn from literature, clinical studies, and real-world experience, to demonstrate the safety, performance, and benefit-risk profile of a medical device.
In Brazil, this is a key requirement under ANVISA Guidance No. 31/2020.
Here’s how we can help you build a compliant and robust submission:
Develop a tailored Clinical Evaluation Plan (CEP) defining methodology, scope, and objectives based on the device and regulatory pathway
Conduct in-depth literature reviews to collect relevant clinical data
Evaluate the quality and acceptability of available data to complete the required dataset
Identify gaps in clinical evidence and assess their impact on risk-benefit analysis
Suggest additional data sources or testing strategies to close identified gaps
Compile a comprehensive and compliant Clinical Evaluation Report, aligned with both Anvisa and global standards
Provide ongoing support for updates, resubmissions, or responses to Anvisa feedback
Why do you need this service?
Clinical Evaluation is not optional—it’s a requirement under Guidance No. 31/2020. Non-compliance can result in rejections, delays, or removal from the market.
We help you build a defensible narrative backed by clinical data, demonstrating that your device works as intended and meets patient safety standards.
With our expert support, you avoid unnecessary testing, reduce internal workload, and streamline the regulatory process focusing only on what’s truly needed.
A well-structured clinical evaluation tailored to Anvisa’s requirements strengthens your product’s credibility and reduces the risk of setbacks during submission. With the right strategy and documentation in place, your device is better positioned for long-term success in the Brazilian market.
Looking for Clinical Evaluation Assistance?
At Sobel, we turn complex clinical demands into structured, regulatory-ready documentation. From planning to reporting, we provide the clarity and technical expertise your team needs to succeed in the Brazilian market.
Let us guide you through Anvisa requirements—effectively, strategically, and without unnecessary delays.
