Key Aspects of Our Biological Evaluation Services
Biological Evaluation Plan (BEP)
We begin with the creation of a structured BEP outlining the assessment strategy for your device. This includes identification of potential biological hazards, applicable endpoints, and selection of test methods based on ISO 10993-1 and relevant guidance documents.
Material Selection and Review
We evaluate the materials used in your device and their contact with the body. Our team assesses material selection decisions based on origin, processing, and history of safe use, minimizing the need for unnecessary testing.
Chemical Characterization
We support or coordinate chemical characterization studies (per ISO 10993-18), evaluating the leachable substances and extractables from your device. These studies are vital to understanding potential exposure and are often required prior to further toxicological evaluation.
Biocompatibility Testing
If testing is required, we plan and manage biocompatibility testing according to ISO 10993 standards. We select accredited laboratories, define test parameters, and ensure results are scientifically justified and properly documented in the BER.
Toxicological Evaluation
We perform or coordinate expert toxicological evaluations for any identified chemical substances or degradation products. Our analysis includes a thorough risk assessment based on toxicological thresholds and clinical relevance.
Equivalence Justification
Where applicable, we support biological safety justifications based on equivalence with existing, tested devices – reducing testing burden and regulatory delays.
BER Compilation and Submission
We compile a detailed, MDR-compliant Biological Evaluation Report (BER) that summarizes all relevant data and testing outcomes. The BER clearly presents the safety justification and integrates it into the overall technical documentation.
Why Choose MDS for Your Biological Evaluation?
Regulatory Accuracy and Expertise
Our experts have in-depth knowledge of biological evaluation under both ISO 10993 and EU MDR frameworks. We ensure your BER and BEP meet notified body expectations and regulatory standards
Efficient Testing Strategy
We take a risk-based approach that minimizes unnecessary material testing and avoids delays – focusing only on the evaluations needed to support a safe and compliant product.
Integrated Support
We coordinate testing, material analysis, and toxicological evaluation, ensuring that the biological assessment is seamlessly integrated into your device’s technical documentation.
Ensuring Biological Safety and Regulatory Compliance
With MDS Denmark’s expert support in biological evaluation, your device will meet the rigorous expectations of the EU MDR. From the initial BEP to the final BER, we guide you through every step—ensuring thorough documentation of material selection, chemical characterization, biocompatibility testing, and toxicological evaluation. Our process ensures safety, reduces risks, and supports successful market approval.