Anvisa Clinical Evaluation for Medical Devices
Clinical evaluation is a cornerstone of medical device submissions in Brazil. Manufacturers must provide documented evidence demonstrating that their device is safe, effective, and performs as intended. At Sobel, we guide you through every stage of the Anvisa Clinical Evaluation process, helping you meet Brazilian regulatory expectations efficiently.
- Manufacturers of medical devices (Class I – IV) seeking clinical documentation in line with Anvisa Guidance No. 31/2020.
- Companies preparing registration or renewal submissions that require a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
- Organizations aiming to update, revise, or reassess existing clinical evaluation documentation.
- Manufacturers of high-risk devices (Class III & IV) that need support defining a clinical evaluation strategy before regulatory submission.
From identifying data gaps to developing and updating compliant documentation, Sobel has the expertise to guide your company through every step of the Anvisa Clinical Evaluation process.
Why do you need this service?
Clinical evaluation is mandatory under Brazilian regulation, forming the foundation of your product’s safety and performance evidence.
A structured Anvisa Clinical Evaluation process reduces the risk of rejection, delays, or additional testing requests.
A well-structured Clinical Evaluation Anvisa supports compliance with international standards and strengthens your readiness for MDSAP audits.
Full compliance across your clinical evaluation lifecycle
Without a Clinical Evaluation, your medical device cannot demonstrate compliance with Anvisa’s clinical safety and performance requirements.
Achieving clinical compliance through Anvisa-aligned evaluation
Related
Services
Sobel develops your clinical evaluation documentation with scientific rigor and regulatory precision, paving the way for compliant and successful submissions in Brazil. You can also complement your Anvisa Clinical Evaluation process with:
Clinical Evaluation Gap Analysis
Identify data gaps, assess available information, and define what is missing to support a strong and compliant clinical evaluation.
Clinical Evaluation Strategy Support
Technical guidance to define your evaluation approach, including comparators, literature sources, and possible study recommendations for Class III and IV devices.
Updates and Revisions
Update or critically review your existing CEP or CER to reflect new data or the latest ANVISA requirements.
If you need any of these complementary services, talk to our consultants — we’ll help you find the right path for your product and regulatory goals.
Strengthen your Anvisa Clinical Evaluation with expert support
Sobel transforms complex clinical requirements into clear, regulatory-ready documentation. With a structured methodology and a multidisciplinary team specialized in Anvisa Clinical Evaluation, we help make your submission scientifically sound, compliant, and strategically aligned with Brazilian regulations.
1. What is Clinical Evaluation according to Anvisa?
Clinical Evaluation is a regulatory process defined in Anvisa Guidance No. 31/2020 and RDC 848/2024, requiring manufacturers to demonstrate a device’s safety and performance through analysis of clinical data, literature, and real-world evidence.
2. Which documents are required for Anvisa Clinical Evaluation in Brazil?
Anvisa requires a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER) as part of the clinical evaluation process for medical devices. The CEP defines the evaluation strategy and methodology, while the CER documents the analysis of clinical evidence and the resulting benefit–risk conclusions to support regulatory submissions.
3. What is the difference between CEP and CER?
The CEP defines the strategy, methodology, and scope for the evaluation, while the CER presents the results, data interpretation, and final clinical evaluation conclusions. Together, they form the complete Anvisa Clinical Evaluation documentation package.
4. When is a Gap Analysis recommended?
A Clinical Evaluation Gap Analysis is useful when a manufacturer wants to check whether existing data are sufficient to meet Anvisa requirements. It identifies missing information and helps determine whether new studies or data sources are necessary.
5. How often should Clinical Evaluation documents be updated?
Updates or revisions are required whenever new clinical data, regulatory changes, or product modifications occur. Under RDC 848/2024, maintaining current CEP and CER versions is key to sustaining market authorization and compliance.
6. How does Clinical Evaluation relate to MDSAP?
Although the MDSAP does not directly assess CEP or CER content, having structured Anvisa Clinical Evaluation documentation demonstrates robust quality processes and supports audit readiness for MDSAP participating authorities.
7. What types of support does Sobel provide?
Sobel offers preparation, updates, and revisions of CEP and CER documents, Clinical Evaluation strategy definition, and Gap Analysis. Our consultants ensure that your documentation meets Anvisa and international expectations.
8. How can I know which service applies to my device?
Our specialists analyze your product’s classification, current data, and regulatory needs to recommend the exact combination of services — whether CEP, CER, Gap Analysis, or Strategy Support — to achieve full alignment with Anvisa Clinical Evaluation requirements.
