Biological Evaluation of Medical Devices
To bring your medical device to the Brazilian market, Anvisa requires strong evidence of biological safety through a BEP and BER. With Sobel, your plans and reports are developed in line with ISO 10993, to achieve compliance and scientific accuracy.
- Medical device manufacturers in development that require a structured plan for biological evaluation.
- Devices with direct or indirect patient contact that must demonstrate biocompatibility under ISO 10993.
- Imported medical technologies that need compliant documentation to obtain Anvisa approval.
- Already registered products facing updates or technical questions from Anvisa that require additional biological evaluation.
Sobel develops your BEP and BER with scientific accuracy and regulatory expertise, paving the way for successful market entry.
Why do you need this service?
Anvisa requires a Biological Evaluation Report (BER) for most devices; without compliant BEP/BER, registration can be delayed or denied.
A structured BEP aligned with ISO 10993 strengthens your biological evaluation of medical devices, reduces technical questions, and de-risks your submission.
An evidence-based approach—leveraging literature, safe-use history, and targeted testing—avoids unnecessary costs and shortens time to market.
Compliance with ISO 10993 and Anvisa
Without BEP and BER, your medical device cannot prove compliance with Anvisa’s biological safety requirements.
Partner with Sobel for strategic planning and reporting that open the doors to the Brazilian market.
Which service applies to your medical device?
At Sobel, you can request only the BEP, only the BER, or both together — depending on your product’s stage and regulatory needs:
BEP:
Recommended for products in development or for manufacturers seeking a clear testing and documentation strategy before starting.
BER:
Required when your testing has been completed and you need a compliant final report for Anvisa submission.
BEP + BER:
The most secure pathway, ensuring strategy and reporting are aligned and minimizing Anvisa rejections.
If your device requires a Gap Analysis, a strategy definition, or updates to existing documents, Sobel also offers complementary services to support your biological evaluation.
Related
Services
Sobel develops your BEP and BER with scientific accuracy and regulatory expertise, paving the way for successful market entry. You can also complement your biological evaluation of medical devices with:
Biological Evaluation Gap Analysis
Identify data gaps, assess the completeness of available information, and define what is missing to support a robust biological risk assessment.
Biological Evaluation Strategy Support
Technical support to define a biological evaluation strategy under ISO 10993, including expert recommendations on necessary tests.
Updates and Revision
Update an existing BEP or critically review a BER already prepared by the manufacturer.
If you need any of these complementary services, talk to our consultants and we will guide you to the right solution for your device.
Expert Support for Biological Evaluation
A strong biological evaluation of medical devices is the foundation of Anvisa approval. With Sobel, your BEP and BER are developed to be scientifically solid, cost-effective, and fully compliant with ISO 10993.
Let Sobel handle compliance so you can focus on innovation and market growth.
Do I really need both a BEP and a BER for Anvisa?
The BER is mandatory for most medical devices submitted to Anvisa. The BEP, while not always required, is highly recommended because it defines the biological evaluation strategy and reduces the chance of Anvisa raising technical questions.
What is the difference between BEP and BER?
The BEP (Biological Evaluation Plan) outlines the strategy, categorization, and testing requirements for your device in accordance with ISO 10993. The BER (Biological Evaluation Report) consolidates results, literature data, and risk analysis into a final scientific document proving the biological safety of your product.
How does a BEP or BER help with my device registration?
A well-prepared BEP and BER accelerate approval by reducing regulatory risks. Instead of facing multiple technical requirements, you submit clear, audit-ready documentation that supports Anvisa acceptance.
Can existing international reports be used for Anvisa?
Yes, but often they need to be complemented or reorganized to align with ISO 10993 and Brazilian requirements. Sobel reviews and adapts these documents to fit Anvisa’s expectations.
Do I need to repeat all tests for the BER?
Not always. ISO 10993 allows the use of existing literature, historical safe use, and previously generated test data. Sobel’s approach combines these elements with targeted testing only when necessary, saving time and cost.
How long does it take to prepare a BEP or BER?
It depends on the complexity of your device and the data available. With organized documentation, Sobel provides a clear timeline and delivers complete, audit-ready documents within agreed deadlines.
