Biological Evaluation
Biological Evaluation for Medical Devices
Our biological safety assessment services ensure that your medical devices comply with the essential safety and biocompatibility regulations. Our knowledgeable team is committed to assisting you in navigating the complex regulatory landscape and ensuring the safety of your device.
The Importance of Biological Safety Assessment
Biological safety is a vital aspect of the medical device certification process. It evaluates the compatibility of the materials used in your device to confirm that they do not cause harmful biological responses which implies that the safety and performance requirements under MDR 2017/745 is met. This assessment is crucial for obtaining regulatory certification and safeguarding patient well-being.
What We Do?
Comprehensive Biological Evaluation
& Toxicology Risk Assessment Support
MEDRA offers specialized support across the entire biological evaluation process including toxicology risk assessment, from Biological Evaluation Plan (BEP), material characterization and Toxicological Risk Assessment (TRA) to benefit-risk analysis, define required biocompatabilty testing, Biological Evaluation Report (BER) and notified body submission support. Our services are aligned with EU MDR 2017/745 requirements and applicable guidance to support robust, defensible biological evaluations.
Biological Evaluation Plan (BEP)
We create a comprehensive BEP that specifies the necessary tests and evaluations for your device, tailored to its materials and intended purpose. This plan guarantees that all potential biological risks are recognized and managed.
- Identification of device materials.
- Risk assessment of biological hazards.
- Selecting necessary biocompatibility testing.
- Testing deliverable and time line.
Toxicological Risk Assessment (TRA)
- The intended patient population group.
- Time of exposure.
Risk Assessment
We conduct comprehensive evaluations to all identified possible biological risks linked to the materials used in your device. Following these evaluations, we create and execute mitigation plan to any risks that have been identified.
- Hazard identification.
- Harm to patient.
- Risk control measures.
- Risk assessment documentation.
Biological Evaluation Report (BER)
We develop BER in line with the MDR 2017/745 requirements to assess the biocompatibility of medical devices with all identified biological risks.The report must:
- Follow a science-based, risk-driven approach aligned with ISO 10993-1.
- Ensure complete documentation of biological risks and mitigation strategies.
- Justify the selection or omission of tests in the context of intended use.
Regulatory Compliance
The biological evaluation process is not just about conducting tests; it follows a scientific risk-based approach that considers the interaction between the medical device and the human body throughout its entire lifecycle. This evaluation must be performed according to ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing and must demonstrate that a device is safe for its intended purpose.
Regulatory & Lifecycle Support
- Regulatory review support aligned with notified body expectations.
- Preparation of written responses to notified body questions.
- Biological Evaluation updates and periodic review support
- Post market surveillance.
How We Work
Our Proven 5-Step biological evaluation Workflow
We deliver efficient, EU MDR-compliant Biological Evaluation Plan (BEP), Biological Evaluation Reports (BER) and Toxicological Risk Assessment (TRA) through a transparent, collaborative process designed to satisfy notified body expectations.
1
Material Characterisation and Risk Assessment
Before testing, the manufacturer must gather information on:
- Device composition (materials, coatings, adhesives).
- Manufacturing processes (including sterilization, surface treatments).
- Expected patient contact (duration, frequency, and exposure sites).
This step eliminates unnecessary testing if material safety can be demonstrated through existing data.
2
Determination of Biological Risks Based on ISO 10993-1
ISO 10993-1 provides a decision-making framework for biological evaluation. The standard defines biological endpoints that need to be assessed based on the device’s:
- Nature of body contact (e.g., skin, mucous membrane, blood).
- Duration of contact (e.g., short-term, prolonged, permanent).
3
Data Appraisal & Benefit-Risk Analysis
We critically appraise all clinical data sources and develop structured benefit-risk analyses to define necessary biocompatibility testing.
4
Biocompatibility Testing (if required)
If gaps in material safety data exist, the manufacturer conducts biological tests, such as:
- Cytotoxicity (ISO 10993-5) – Evaluates if materials cause cell damage.
- Sensitization (ISO 10993-10) – Identifies allergic reactions.
- Irritation (ISO 10993-10) – Tests for local tissue irritation.
- Systemic toxicity (ISO 10993-11) – Assesses potential toxic effects on organs.
If chemical characterization and existing data are sufficient to demonstrate safety, some tests can be waived, reducing the need for animal studies.
5
Justification of Biocompatability Regulatory
A biological evaluation report (BER) is compiled, summarizing:
- Data from material characterization.
- Risk assessment findings.
- Testing results (if applicable).
- Rationale for omitting tests (if applicable).
This report must be included in the technical documentation submitted for regulatory approval.
Why Choose MEDRA for Biological Evaluation:
MEDRA provides strategic, regulatory compliant BEP, TRA&BER for medical device manufacturers. Our approach combines regulatory expertise, scientific rigor, and clear documentation to support robust clinical evaluations and informed regulatory review.
Dedicated Biological Evaluation Experts
Clients are supported by experienced BEP,TRA & BER writers who lead biological evaluation strategy, and benefit-risk analysis, ensuring a focused, defensible approach tailored to each device and its intended purpose.
Integrated Authoring Across the Technical File
We develop and integrate biological evaluation documentation, clinical evaluation, and benefit-risk conclusions per all applicable regulatory requirements.
Predictable, High-Quality Execution
Our team synthesizes biological evaluation data including the raw material assessment and characterization at early stage of the design and development process and, well-structured BEP, TRA & BER content, supported by structured quality and consistency reviews to support regulatory review readiness.
Turning Biological Evaluation into Regulatory Documentation
We translate complex biological and chemical data into clear, defensible regulatory narratives that support the demonstration of safety and performance and inform benefit-risk conclusions across the device lifecycle.
