Biological Evaluation
Placing a medical device on the European market demands clear, evidence-based proof of biological safety, as mandated by the MDR (EU 2017/745), for successful CE marking. That’s why achieving EU compliance and demonstrating biocompatibility requires a comprehensive biological evaluation strategy.
Our expert-led biological evaluation service helps manufacturers navigate this crucial process with confidence. Whether you’re developing a Biological Evaluation Plan (BEP) or reviewing a full report, our team prepares documentation aligned with the requirements of ISO 10993 biological evaluation of medical devices—laying the foundation for safe, compliant, and successful market entry.
How We Support Your Biological Evaluation
We assist companies at different stages of the biological evaluation workflow—whether you’re starting from scratch or need help reviewing and updating existing documents. We can help your company with:
Development or Update of the Biological Evaluation Plan (BEP): We define your evaluation strategy based on the type of device, contact duration, and nature of body contact. The plan outlines phases, documentation, and testing needs.
Technical Review of Existing Documentation: Already have a biological evaluation report? We perform a detailed review of the existing content, identify gaps or outdated sections, and guide you on how to bring it into alignment with the latest regulatory standards.
Critical Risk Analysis & Evaluation: We assess available data on chemical composition, physicochemical properties, manufacturing and packaging processes, and global use history. When applicable, we compare your device to similar commercial products to support equivalence claims.
Biological Testing Recommendations: If the available data is insufficient, we help select and justify the appropriate biological assays (e.g., cytotoxicity, irritation, sensitization), always based on a risk-based approach.
Regulatory-Ready Documentation: All evaluations are documented in a structured and compliant format—ready to be included in your technical documentation per Annex II of the MDR.
With a compliant BEP and a well-structured biological evaluation report, your submission becomes easier to defend, and your chances of CE marking approval increase significantly.
Why do you need this service?
The ISO 10993 biological evaluation framework and the MDR (EU 2017/745) demand scientific proof that your device poses no unacceptable biological risk. Sobel’s team checks if your documents meet those expectations and are ready for review by Notified Bodies.
By evaluating risks early, you avoid surprises during the approval process. Our approach helps identify what’s needed, saving valuable time, budget, and resources.
From analyzing clinical use history and assessing equivalence, our experts help you build a smart and efficient biological evaluation strategy tailored to your device and risk class.
A well-executed biological evaluation of medical devices isn’t just about meeting regulatory requirements—it’s about protecting patients and supporting long-term product success in the European market. Sobel can guide you throughout this entire journey, turning complex challenges into clear, manageable steps.
Need support with your biological evaluation?
Let’s assess whether your device is truly ready for safe and successful entry into the European market. Whether you need to develop a complete Biological Evaluation Plan, update existing documentation, or determine the need for additional testing, Sobel is here to help you meet EU regulatory expectations with clarity, precision, and efficiency.
