ISO 10993-1:2025 · Biological Evaluation Plan (BEP) & Report (BER)
Update Your BEP/BER to ISO 10993-1:2025 — Effects-Based, Risk-Justified, Submission-Ready
Update your Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) so they follow the ISO 10993-1:2025 risk-based structure: biological effects instead of legacy endpoints, ISO 14971-style risk estimation (severity, probability, uncertainty), and explicit linkage to chemistry (ISO 10993-18) and toxicological risk assessment (ISO 10993-17:2023). The outcome: clear, traceable decisions reviewers can follow.
Consulting & documentation only
Effects-based risk evaluation
Chemistry & TRA integrated
When It’s Time to Update Your BEP/BER for ISO 10993-1:2025
Typical situations where keeping legacy BEP/BERs is no longer acceptable:
- Your BEP/BERs are written to earlier ISO 10993-1 editions and still organized around “endpoints” rather than biological effects.
- Reviewer feedback is asking for stronger risk-management language, clearer rationales, or explicit links to ISO 14971.
- Your chemistry reports (ISO 10993-18) and toxicological risk assessments (TRA, ISO 10993-17:2023) exist, but the BEP/BER does not clearly show how they support the final conclusion.
- You need to show foreseeable misuse and realistic worst-case exposure scenarios in a way that matches the 2025 edition.
- You want consistent, transparent BEP/BER structures across multiple devices and submissions, avoiding one-off interpretations.
Why ISO 10993-1:2025 Changes How Your BEP/BER Should Look
ISO 10993-1:2025 reinforces that biological evaluation is part of risk management, not a test checklist. This has direct consequences for how BEPs and BERs are written.
- Effects-based framing: The standard moves away from a static “endpoint list” toward biological effects. Your BEP must show how contact type/duration leads to a defined set of biological effects to be addressed.
- Risk estimation language: Severity, probability, and uncertainty are now central. Your BER should document how risks are estimated and why the residual risk is acceptable.
- Foreseeable misuse: Use beyond the intended duration or off-label patterns must be considered where there is evidence or a realistic pattern — and reflected in the evaluation.
- Integration of 10993-18 and 10993-17:2023: Chemistry (what is there and how much can be released) and toxicological risk assessment (is that exposure acceptable?) must be explicitly connected to the BEP/BER conclusions.
Regulators in the EU treat the latest edition as state of the art. In the US, expectations are framed by FDA biocompatibility guidance and recognition of standards, but the direction is the same: risk-based, transparent, and traceable reasoning in your BEP/BER.
What You Get When We Update Your BEP/BER
The focus is on precise, regulator-ready documents — not generic training and not laboratory testing.
Updated BEP (Biological Evaluation Plan)
- Clear scope, device description, intended use, and patient-contact profile.
- Mapping from contact category and exposure duration to a defined set of biological effects to be evaluated.
- Data sources (existing chemistry, biology, clinical, literature) and acceptance criteria.
- Consideration of foreseeable misuse where relevant (e.g., extended use beyond IFU).
Updated BER (Biological Evaluation Report)
- Structured summary of all relevant evidence (chemistry, TRA, biological tests, clinical and literature).
- Documented severity, probability, and uncertainty for relevant biological harms, following ISO 14971 concepts.
- Transparent acceptance rationale explaining why residual risk is acceptable, including any conservative assumptions.
- Final conclusions clearly tied back to the BEP and to the device’s intended clinical context.
Biological Effects Mapping
- Explicit mapping from contact category/duration to biological effects, aligned with the new ISO 10993-1:2025 structure.
- Support tables or diagrams that can be reused across multiple devices in your portfolio.
Chemistry & TRA Linkage Notes
- How ISO 10993-18 data (identification, quantification, exposure estimates) flow into toxicological risk assessment (ISO 10993-17:2023).
- How toxicological conclusions (TI/TTC, margins of safety, uncertainty factors) underpin the acceptability statements in the BER.
- Clear statement of major assumptions and uncertainties and how they are controlled.
Change Log and Submission Cues
- Concise change log summarizing what was updated versus the prior BEP/BER and why.
- Short notes on where and how to place the updated documents in EU MDR and FDA submissions.
- Phrasing cues aligned with how reviewers typically read and reference the BEP/BER.
Consulting and documentation only — we do not perform laboratory testing.
How We Work on Your BEP/BER (6 Steps)
A structured process designed to reuse existing evidence and recommend new testing only when residual risk and uncertainty demand it.
Discovery & intake
Reframe to ISO 10993-1:2025
Risk estimation pass
Evidence appraisal
Draft BEP/BER updates
Handover & submission support
Inputs We Need From Your Team
- Device list with intended use, materials, contact category (e.g. intact skin, mucosal, blood/tissue) and contact duration.
- Current BEPs/BERs and any applicable biological evaluation procedures or templates.
- Available chemistry reports (ISO 10993-18) and toxicological risk assessments (ISO 10993-17:2023 or equivalent).
- Target markets and submission types (EU MDR, FDA, other jurisdictions) to tailor submission cues.
- Any internal risk management scales or SOPs we should align with.
Why Regulatory and R&D Teams Work With Sobel on BEP/BER Updates
Sobel supports manufacturers with biocompatibility, toxicology, and regulatory strategy across the U.S., EU, Brazil, and other major markets. The emphasis is on coherent risk reasoning, not on ticking tables.
- BEP/BER documentation aligned with ISO 10993-1:2025 and ISO 14971, rather than legacy endpoint lists.
- Explicit integration of ISO 10993-18 chemistry data and ISO 10993-17:2023 toxicological risk assessment into the final conclusions.
- Consistency of decisions and documentation across your device portfolio.
- Reviewer-oriented writing style that anticipates typical authority questions and reduces avoidable back-and-forth.
- Clear, evidence-based approach that minimizes unnecessary new testing while remaining defensible.
FREQUENTLY ASKED QUESTIONS
The standard now expects an effects-based framing, stronger integration of risk estimation (severity, probability, uncertainty) and explicit consideration of foreseeable misuse. BEPs and BERs need to show how biological risks are identified, estimated, and justified — not just list tests.
Not automatically. New testing is only recommended where the risk-based review of existing chemistry, biological, clinical, and literature data shows that residual risk or uncertainty is not adequately controlled or documented.
ISO 10993-18 defines what chemicals are present and at what exposure levels. ISO 10993-17:2023 defines how to evaluate whether that exposure is acceptable from a toxicological perspective. The BEP/BER must show how those inputs support the final acceptability conclusion for each relevant biological effect.
ISO 10993-1:2025 (Edition 6) has been published. In the EU, the latest edition is generally considered state of the art, so Notified Bodies will expect your documentation to reflect it. In the US, application depends on FDA recognition and guidance updates. You should confirm expectations with your Notified Body and follow FDA communications while preparing for the risk-based structure now.
Get BEP/BER Updates That Match ISO 10993-1:2025 and Reviewer Expectations
If your BEPs and BERs still reflect earlier ISO 10993-1 editions, now is the time to update them. We help you convert existing evidence into clear, effects-based and risk-justified documentation — so reviewers can follow your reasoning from chemistry and toxicological risk through to final conclusions.
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