Biological safety remains a critical part of bringing a medical device to market under EU MDR (EU 2017/745). Two documents in particular matter: the Biological Evaluation Plan (BEP), which lays the groundwork for identifying and managing biological risks; and the Biological Evaluation Report (BER), which compiles evidence to show you’ve done so. With the upcoming ISO 10993-1 revisions, there are new expectations that manufacturers should begin preparing for — especially around lifecycle, misuse risks, and documentation.
What Are BEP & BER?
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The BEP is your roadmap. It defines how potential biological hazards will be identified, what testing or evaluations are required (in vitro, in vivo, chemical, literature, etc.), how to characterize materials, how to integrate existing data, and how risk is managed.
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The BER is where you show your work: summarizing test results, risk analyses, clinical or literature evidence, any gaps, and your conclusions about safety. It supports your technical file and regulatory submissions under MDR.
What’s Changing in ISO 10993-1:2025 & Draft Revisions
Recent and draft revisions to ISO 10993-1 are bringing important updates that affect how BEPs and BERs should be done. Some key changes:
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Risk Management Integration: The new draft emphasizes that BEP must be deeply embedded in risk management (linked to ISO 14971). Biological risks, including foreseeable misuse, should be assessed as part of the general product risk evaluation.
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Lifecycle Approach: More emphasis on ensuring safety over the entire device lifecycle (manufacturing, storage, use, reuse if applicable, disposal/minimal exposure changes). Changes in material, degradation, and exposure over time must be considered.
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Device Contact and Duration Clarifications: The draft standard clarifies categories of device contact (skin, mucosal, internal tissues etc.), and refines how exposure duration and contact type influence which biological effects/endpoints must be evaluated.
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Stronger Documentation Requirements: The draft moves many things previously in informative annexes into the normative body of the standard. BEP documentation must include the acceptability criteria for biological risks, probabilities and severities per risk assessment, and justifications for the choices. Also, the qualifications of those preparing and reviewing BEPs/BERs are more strictly expected.
Why Literature Search in the BEP Is Crucial
One of the foundational elements of a strong BEP is a comprehensive literature search. Here’s why it matters:
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It helps identify existing data (clinical, preclinical, scientific literature) that may reduce the need for redundant testing.
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It establishes the state-of-the-art — essential for showing your device is at least as safe/performance-capable as existing alternatives.
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It supports risk assessment: you may identify hazards others have discovered, or find data about similar materials or devices under comparable conditions.
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Reviewers (Notified Bodies, authorities) increasingly scrutinize literature searches — methodology, search terms, inclusion/exclusion criteria, documentation of reasoning. If the literature search is weak or poorly documented, it may trigger nonconformities.
What This Means in Practice — What Manufacturers Should Do
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Start planning for ISO 10993-1:2025. If your device is under design or early documentation, align your BEP to the risk-based, lifecycle-oriented expectations.
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Make sure BEPs are documented with clear acceptability criteria, defined risk management, contact type/duration, exposure over life, and qualifications of experts.
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Ensure that your literature searches are systematic and well-documented (search strategy, databases, inclusion/exclusion criteria, etc.). Include state-of-the-art searches and device-oriented searches.
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Use BERs not just to report results but to integrate literature, test data, chemical characterization, identify gaps, and show how risks are mitigated.
Wrapping Up: Why BEP & BER Matter More Than Ever
With the upcoming standard changes and increasing scrutiny from regulatory bodies, BEP and BER are no longer just regulatory “check-boxes”—they’re strategic tools. They define whether your device’s biological safety case is solid or whether you will face questions, delays, or even re-work.
At MDS, we help prepare BEPs and BERs that are aligned with the latest ISO 10993 draft expectations, designed to meet MDR’s GSPR requirements, and built to anticipate the questions authorities will ask.
To learn more about how our services can support your BEP/BER strategy and ensure your biological safety documentation is ready for current and upcoming regulatory expectations, contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
