Biocompatibility testing
Navigate the complexities of biological safety with Europe’s most modern laboratory. We provide end-to-end biocompatibility evaluation to ensure your medical device is safe, compliant, and ready for global markets.
Biocompatibility refers to the complex interaction between a medical device and the physiological systems of the patient. Ensuring that your device does not elicit an adverse local or systemic response is a fundamental requirement of the MDR 2017/745 and global regulatory frameworks. At EBI, we evaluate biocompatibility within a strict risk management process, following the latest ISO 10993-1 standards.
Our Approach: Evaluation Within Risk Management
Biocompatibility is no longer just a „checklist” of animal tests. Modern regulatory expectations prioritize a tiered approach:
1. Biological Evaluation Plan (BEP): Strategy and risk identification.
2. Chemical Characterization: Understanding what can leach from your device.
3. In Vitro & In Vivo Testing: Targeted biological assays based on the nature and duration of body contact.
4. Biological Evaluation Report (BER): Final expert assessment and safety conclusion.
Comprehensive Biocompatibility Test Portfolio
EBI operates some of the most advanced laboratories in Europe. We offer a full spectrum of routine and specialized tests classified by contact nature (Surface, External Communicating, or Implant) and duration.
Planning & Chemical Analysis
- [Biological Evaluation Plan (BEP)]: Strategy and gap analysis.
- Chemical Characterization: Identifying extractables and leachables (E&L).
- Toxicological Risk Assessment: Evaluating the safety of identified chemicals.
Core Biocompatibility Assays
- [Cytotoxicity Testing]: Qualitative (MEM Elution, Direct Contact) and Quantitative (MTT, XTT, NRU) methods.
- Irritation: In vitro skin models and Intracutaneous reactivity.
- Sensitization: GPMT (Guinea Pig Maximization), LLNA, and Buehler assays.
- Material-Mediated Pyrogenicity: Ensuring devices do not cause fever responses.
- [Bacterial Endotoxin Testing (LAL)]: Detecting pyrogenic contaminants.
Systemic & Long-term Toxicity
- Acute, Subacute, & Subchronic Toxicity: Assessing systemic effects.
- Genotoxicity: AMES Assay and Mouse Lymphoma Assay (MLA).
- Implantation Studies: Subcutaneous, Muscle, and Bone implantation to assess local tissue response.
Specialized Testing
- Hemocompatibility: Analysis of Hemolysis, Coagulation, Platelet Activation, and Complement Activation.
- [EO & ECH Residual Testing]: Analysis of sterilization gases (ISO 10993-7).
- [Biological Evaluation Report (BER)]: The final safety summary for your Technical File.
Why Choose EBI Laboratories?
Modern Infrastructure:
Our labs are among the most technologically advanced in Europe, ensuring high precision and reproducible results.
Cost-Effective Solutions:
We advise on the most efficient testing routes, often using chemical characterization and rationales to avoid unnecessary biological tests.
Regulatory Authority:
Our reports are designed for seamless acceptance by Notified Bodies (CE Mark), the FDA, and other global regulators.
ISO 17025 Accredited:
Highest quality standards for testing and calibration.
FAQ: Frequently Asked Questions
How do I know which tests are required for my device?
Requirements depend on the device’s classification (Nature and Duration of contact) as per ISO 10993-1 Table A.1. Our team can help you define a custom Biological Evaluation Plan (BEP) to identify your specific testing needs.
Can chemical characterization replace animal testing?
In many cases, yes. Regulatory bodies increasingly accept chemical data and toxicological assessments to justify the omission of certain in vivo tests, such as systemic toxicity or genotoxicity.
What is the „Nature of Contact”?
Devices are categorized as Surface-contacting (skin/mucosa), External-communicating (blood path/tissue/bone), or Implanted. Each category has different biological endpoints that must be addressed.
How do I know which tests are required for my device?
Requirements depend on the device’s classification (Nature and Duration of contact) as per ISO 10993-1 Table A.1. Our team can help you define a custom Biological Evaluation Plan (BEP) to identify your specific testing needs.
Can chemical characterization replace animal testing?
In many cases, yes. Regulatory bodies increasingly accept chemical data and toxicological assessments to justify the omission of certain in vivo tests, such as systemic toxicity or genotoxicity.
What is the "Nature of Contact"?
Devices are categorized as Surface-contacting (skin/mucosa), External-communicating (blood path/tissue/bone), or Implanted. Each category has different biological endpoints that must be addressed.
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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