Biocompatibility Evaluation — Smart, Science-Based, Cost-Efficient
ISO 10993-1:2018 fundamentally changed the biocompatibility game: physical and chemical characterization data can now substitute for many animal tests. MEGACERT's biocompatibility specialists help you build a defensible biological evaluation strategy that minimizes testing costs while fully satisfying MDR requirements.
The Risk-Based Approach to Biocompatibility Under ISO 10993-1:2018
Many manufacturers still approach biocompatibility as a checklist of tests to run. The 2018 revision of ISO 10993-1 fundamentally reframed this: biocompatibility is a risk management process, and testing is only one tool among many.
The biological evaluation process begins with understanding:
- Patient contact — Nature (direct/indirect), duration (limited/prolonged/permanent), and body location (surface/external communicating/implant)
- Materials of construction — Chemical composition, processing residuals, degradation products
- Existing data — Published literature on materials, legacy test reports, predicate device data
Only after this analysis is it possible to determine which — if any — biocompatibility tests are actually needed.
Our Biocompatibility Services
Biological Evaluation Plan (BEP)
A structured plan identifying the device's biological endpoints of concern based on ISO 10993-1 Annex A, existing data sources, and a justified decision on whether testing is needed for each endpoint.
Chemical Characterization (ISO 10993-18)
Extractables & leachables assessment. We help you select analytical test methods or review existing chemical characterization reports against MDR/MDCG 2021-2 expectations.
Literature-Based Biological Evaluation
For established materials (e.g., medical-grade silicone, stainless steel 316L, UHMWPE), we conduct systematic literature reviews demonstrating biocompatibility without new animal testing.
Test Protocol Review & Lab Coordination
Where testing is needed, we draft test protocols, select accredited laboratories (ISO 17025), and review test reports for compliance with ISO 10993 part requirements.
Biological Evaluation Report (BER)
The completed report integrating all BEP outcomes, characterization data, literature findings, and test results into a cohesive biological safety conclusion — structured for direct inclusion in your MDR Technical File.
Frequently Asked Questions
Ready to minimize your biocompatibility testing costs while building MDR-compliant documentation? Contact MEGACERT for a free BEP assessment.
Get a Biocompatibility Strategy Assessment →