Biological Evaluation Plan & Report (BEP/BER) - ISO 10993-1
From strategy to safety conclusion – EBI provides the full biological evaluation workflow required to bring your medical device to market.
Biological evaluation is a structured, risk-based process – not a checklist of laboratory tests. Under ISO 10993-1:2018, every medical device that contacts the human body must be systematically evaluated for biological safety. This process begins with a documented strategy (the BEP) and concludes with a comprehensive safety assessment (the BER). At EBI, our qualified assessors manage both documents, ensuring a seamless path from hazard identification to regulatory submission.
What Is Biological Evaluation - and Why Does It Matter?
Regulators under MDR 2017/745 and global frameworks (FDA, ISO) require manufacturers to demonstrate that their device will not cause harm to patients or users. The biological evaluation process provides this evidence by combining material data, chemical characterization, toxicological analysis, and – where necessary – targeted laboratory testing. A properly executed BEP and BER can significantly reduce the need for costly animal studies and accelerate your path to certification.
Two Documents. One Integrated Process.
The BEP and BER are not independent deliverables – they are the opening and closing chapters of the same scientific narrative.
Biological Evaluation Plan (BEP)
Biological evaluation is a structured, risk-based process – not a checklist of laboratory tests. Under ISO 10993-1:2018, every medical device that contacts the human body must be systematically evaluated for biological safety. This process begins with a documented strategy (the BEP) and concludes with a comprehensive safety assessment (the BER). At EBI, our qualified assessors manage both documents, ensuring a seamless path from hazard identification to regulatory submission.
Biological Evaluation Report (BER)
The BER is your safety conclusion. It synthesizes all available evidence – laboratory data, chemical characterization results, clinical literature, and expert rationales – into a single submission-ready document. The BER provides the formal statement required by Notified Bodies and regulatory authorities confirming that your device meets the biological safety requirements of its intended application.
The EBI Biological Evaluation Workflow
Our process follows the ISO 10993-1 framework from start to finish:
Device & Material Characterization
We define the nature and duration of body contact and identify all tissue-contacting materials, including residues and packaging components.
Gap Analysis & Literature Review
We systematically evaluate existing data - published literature, supplier documentation, and internal test records - to identify what is already known and what needs to be addressed.
Biological Hazard Identification & Test Planning
Based on the device classification and ISO 10993-1 Table A.1, we identify all relevant biological endpoints and determine which require new experimental data versus scientific rationale.
Testing or Rationale Justification
Where data gaps exist, we coordinate targeted laboratory testing. Where existing evidence is sufficient, we prepare documented rationales to justify non-testing - reducing animal studies and saving costs.
Final Assessment & Regulatory Submission
Our qualified experts issue a formal BER with a definitive safety conclusion, ready for submission to your Notified Body or regulatory authority.
Standards & Compliance
All EBI biological evaluations are conducted in strict accordance with:
- ISO 10993-1:2018/2025: Biological evaluation within a risk management process.
- MDR 2017/745: European Medical Device Regulation technical file requirements.
- ISO 14971: Risk management for medical devices.
- FDA Guidance on ISO 10993 (2020): US-specific biocompatibility expectations.
FAQ: Biological Evaluation Plan & Report
What is the difference between a BEP and a BER?
The BEP is a prospective planning document – it defines the strategy before any evaluation begins. The BER is the final report – it documents all evidence gathered and provides the expert safety conclusion. Both are required for a compliant technical file under MDR.
Do I need both a BEP and a BER?
Yes. ISO 10993-1 and MDR 2017/745 require both documents. The BEP defines your evaluation strategy upfront; the BER closes the loop with a formal safety assessment.
Can a BEP help me avoid animal testing?
Yes. One of the primary goals of the BEP is to identify where existing chemical data, literature, or material history can replace new in vivo studies. Modern standards actively encourage this approach to reduce animal use.
Who is qualified to write a BEP or BER?
ISO 10993-1 requires these documents to be authored by suitably qualified and experienced persons. EBI’s team consists of expert assessors specialized in biocompatibility, toxicology, and regulatory affairs.
When should the BEP be updated?
The BEP should be reviewed whenever there is a change in manufacturing process, raw material suppliers, or when new clinical safety data for the materials becomes available.
What is the difference between a BEP and a BER?
The BEP is a prospective planning document – it defines the strategy before any evaluation begins. The BER is the final report – it documents all evidence gathered and provides the expert safety conclusion. Both are required for a compliant technical file under MDR.
Do I need both a BEP and a BER?
Yes. ISO 10993-1 and MDR 2017/745 require both documents. The BEP defines your evaluation strategy upfront; the BER closes the loop with a formal safety assessment.
Can a BEP help me avoid animal testing?
Yes. One of the primary goals of the BEP is to identify where existing chemical data, literature, or material history can replace new in vivo studies. Modern standards actively encourage this approach to reduce animal use.
Who is qualified to write a BEP or BER?
ISO 10993-1 requires these documents to be authored by suitably qualified and experienced persons. EBI’s team consists of expert assessors specialized in biocompatibility, toxicology, and regulatory affairs.
When should the BEP be updated?
The BEP should be reviewed whenever there is a change in manufacturing process, raw material suppliers, or when new clinical safety data for the materials becomes available.
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Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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