Biological Evaluation for Medical Device (ISO 10993 BEP & BER)

A biological evaluation for a medical device requires a structured, risk-based approach aligned with ISO 10993-1 and the FDA’s Guidance for Use of ISO 10993-1. Sobel supports manufacturers by developing Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and strategic documentation that demonstrate biological safety in alignment with FDA expectations.

For who?

Manufacturers of legacy devices with historical use but incomplete biocompatibility documentation.
Companies preparing 510(k), PMA, or De Novo submissions.
Devices with complex materials, coatings, additives, or unclear chemical profiles.
Teams needing expert guidance on FDA expectations for biological evaluation of medical devices.
Organizations seeking a structured, risk-based approach to biological safety.

With a clear strategy and well-supported justification, your submission becomes more predictable, efficient, and scientifically defensible.

Why do you need this service?

Manufacturers must demonstrate biological safety using an ISO 10993–aligned, risk-based approach that meets FDA expectations for medical device submissions.

Legacy or partially documented devices often lack complete material, toxicological, or historical data, requiring structured evaluation and scientific justification.

A clear, defensible biological evaluation medical device package reduces FDA questions, avoids unnecessary testing, and strengthens your overall regulatory strategy.

Biological evaluation requirements for medical devices

Biological evaluation for medical devices requires a structured, risk-based assessment aligned with ISO 10993-1, including material characterization, toxicological risk assessment, and evaluation of patient-contact duration and exposure.

Regulatory authorities such as the FDA and international notified bodies expect manufacturers to document this evaluation through Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) as part of regulatory submissions.

A biological evaluation that supports your regulatory strategy — from planning to final justification.

Strategy Definition

We analyze your device category, materials, clinical history, and intended use to define the most appropriate biological evaluation approach.

Data Compilation and Scientific Review

We gather and interpret historical information, chemical data, toxicological profiles, and any available post-market evidence.

Gap Identification and Recommendations

When data are insufficient, we recommend targeted testing or prepare strong scientific justification for test omission, following ISO 10993-1 and FDA guidance.

Biological Risk Assessment and Documentation

We translate all data into a coherent, risk-based narrative that supports your FDA submission and meets global expectations.

Which service applies to your medical device?

At Sobel, you can request the combined BEP + BER package, or complementary toxicological and strategic services.

BEP + BER:

The most complete pathway, ensuring a consistent strategy and final reporting — reducing FDA questions, omissions, and review delays.

Toxicological Risk Assessment (TRA)

Toxicological review of relevant materials, components, substances, historical use, exposure, and biological safety data.

Support for Biological Evaluation Issues

Technical guidance to define a biological evaluation strategy following ISO 10993-1 and FDA guidance, including expert recommendations for necessary tests.

Related
Services

Sobel strengthens your entire biological evaluation medical device process with complementary services that support FDA submissions:

Regulatory training

Expert-led training to help teams understand ISO 10993-1 and FDA expectations.

Regulatory Consulting

Support for Premarket Notification 510(k), FDA submissions, registration, UDI, and more.

Supplier Audit and Qualification

Strengthen your supply chain with supplier audit and qualification services.

Get Expert Biological Evaluation Support

Let Sobel guide you through a structured, compliant, and efficient biological evaluation process for your medical device. We translate all data into a coherent, risk-based narrative that supports your FDA submission and meets global expectations.

Still have questions? Checkout our FAQ

1. What is a Biological Evaluation Plan (BEP)?

A BEP outlines the strategy, rationale, and steps your company will follow to demonstrate biological safety under ISO 10993 and FDA guidance.

2. When should I prepare a BEP for my device?

A BEP should be developed before conducting biocompatibility testing or updating historical data. It ensures that testing, justification, and data collection are aligned with the FDA’s expectations for your specific device category, materials, and patient-contact profile.

3. What is a Biological Evaluation Report (BER)?

A BER consolidates all biocompatibility data, toxicological evaluations, test results, historical information, and scientific justification into a final risk-based conclusion regarding biological safety for FDA submission.

4. When is a BER required?

A BER is required once testing and data collection have been completed, and you must present a complete biological safety assessment for 510(k), PMA, or De Novo submissions.

5. Does the FDA accept BEPs and BERs developed under ISO 10993-1?

Yes. The FDA aligns with ISO 10993-1 but applies additional expectations outlined in the FDA Guidance for Use of ISO 10993-1. A submission must satisfy both the international standard and U.S.-specific interpretations.

6. Can I use historical data instead of performing new testing?

Yes — if justified. The FDA allows the use of existing biocompatibility data, including previous testing, material information, or toxicological literature. However, justification must be scientifically sound, clearly documented in the BEP, and fully interpreted in the BER.

7. What if my device is a legacy product with outdated or incomplete biocompatibility data?

This is very common. A BEP can define a modern strategy for updating or supplementing legacy documentation. The BER will consolidate new and historical evidence, providing a risk-based conclusion aligned with current FDA expectations.

8. Which documents are typically required to complete a biological evaluation for medical devices?

A complete biological evaluation typically includes a Biological Evaluation Plan (BEP), Biological Evaluation Report (BER), chemical characterization data, toxicological risk assessment when applicable, and supporting risk management documentation aligned with ISO 10993 and ISO 14971 requirements.