Biological Evaluation Plan (BEP)
Minimize testing costs and accelerate market access with a risk-based Biological Evaluation Plan. We turn regulatory requirements into a clear, actionable roadmap for your medical device.
The Biological Evaluation Plan (BEP) is the first and most critical step in the biocompatibility process. Rather than jumping straight into expensive laboratory tests, ISO 10993-1:2018 requires a prospective, risk-based approach. At EBI, we analyze your device’s raw materials, manufacturing processes, and existing data to determine exactly which risks need to be addressed and which tests can be safely justified as unnecessary.
The Purpose of a BEP: Strategy Over Checklist
A Biological Evaluation Plan is not just a list of tests; it is a documented strategy used to prove device safety while avoiding redundant animal testing. Because biological evaluation is a risk management activity, the BEP forms an integral part of your Risk Management Plan.
A well-structured BEP allows you to:
- Identify Potential Risks: Evaluate hazards based on raw materials, packaging, and production conditions.
- Define Testing Strategy: Conclude which experimental data is needed to comply with MDR and FDA requirements.
- Establish Justifications: Use scientific literature or data from similar products to reduce the testing burden.
- Ensure Design Control: Integrate biological safety into the overall design and review process.
Factors Considered During Biological Evaluation
Our experts conduct a deep dive into the technical characteristics of your device to identify all potential biological hazards. We consider:
- Materials & Configuration: All direct and indirect tissue-contacting materials, including size, geometry, and surface properties.
- Manufacturing & Residues: Intended additives, process contaminants, and residues left behind during production.
- Packaging: Materials that may indirectly contact the device and leach substances.
- Chemical Properties: Leachable substances, degradation products, and physical/chemical characteristics.
- Biological Impact: Systemic and local effects of implantable devices, as well as existing toxicological data.
Identification of Biological Hazards
Based on your product’s classification and the guidance provided in ISO 10993-1:2018 (Table A.1) and the FDA Guidance (2020), EBI identifies the specific biological risks relevant to your device. This ensures that your testing plan is specifically tailored to the nature and duration of body contact.
Extra Considerations for Complex Devices
For advanced medical devices, our BEP also addresses specialized safety parameters such as:
- Biodegradation: Assessing how materials break down within the body.
- Biodistribution: Understanding where particles or leachable substances travel.
- Drug/Device Interaction: Evaluating safety when a device is combined with medicinal substances.
Methodology: How EBI Builds Your Plan
The biological evaluation plan must be drawn up by a knowledgeable and experienced team. Our process includes:
- Information Gathering: Systematic review of published literature and internal Sponsor data.
- Gap Analysis: Comparing existing experimental evidence against current normative requirements.
- Testing Determination: Identifying which requirements must be subjected to new laboratory testing versus those that can be justified through alternative evidence.
- Review & Approval: Formal arrangements for the final review of biological risk assessment outcomes.
Standards & Compliance
Our BEPs are designed to satisfy the most rigorous global regulatory frameworks:
- ISO 10993-1:2025: The gold standard for biological evaluation.
- Regulation (EU) 2017/745 (MDR): Ensuring your technical file is ready for European Notified Bodies.
- FDA Guidance on ISO 10993: Adhering to US-specific expectations for biocompatibility planning.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Biological Evaluation Planning
Is a BEP required before I start laboratory testing?
Yes. Regulatory bodies like the FDA and Notified Bodies under MDR expect a prospective plan. Starting tests without a BEP can lead to „over-testing” (wasting money) or „under-testing” (risking clinical hold or rejection).
Can a BEP help me avoid animal testing?
Absolutely. One of the primary goals of a BEP is to provide a „Rationale for Non-Testing” by using existing chemical data or literature, which is highly encouraged by modern standards to reduce animal use.
When should the BEP be updated?
The plan should be reviewed whenever there is a change in the manufacturing process, a change in raw material suppliers, or when new clinical data regarding the material safety becomes available.
Who should write the Biological Evaluation Report?
According to ISO 10993, the report must be carried out by suitably qualified and experienced persons. Our team at EBI consists of expert assessors specialized in biocompatibility and toxicology.
What is a "Rationale" in a BER?
A rationale is a documented scientific justification explaining why a specific biological test (e.g., a 2-year implantation study) is not required based on existing data, material history, or chemical characterization.
Is a BER required for non-contacting devices?
If a device has no direct or indirect contact with the patient’s body, the ISO 10993-1 standard may not be applicable. However, a brief statement or report confirming this „non-contact” status is often required for the technical file.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
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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