Chemical Characterization of an Orthopaedic Device Family
Case study
Biocompatibility evaluation is an essential part of MDR compliance. The process becomes increasingly complex when devices combine metals, polymers, and ceramics. This case study highlights how Lucideon applied deep materials expertise and rigorous analytical approaches to generate reliable data and support a confident regulatory submission.
The challenge
A client approached Lucideon to perform biocompatibility testing on a product family of 15 orthopaedic devices to support regulatory submissions under the EU Medical Device Regulation (MDR). The devices were made from a combination of metals, polymers, and ceramics, which required a range of materials expertise. Analyzing multiple materials required materials science expertise to ensure that extraction conditions were appropriate and that chemical characterization was scientifically robust.
Extraction conditions had to be tailored to account for the different solubility and diffusion behaviors of metals, polymers, and ceramics. Furthermore, the chemical characterization needed to be detailed enough to support a toxicological risk assessment in line with ISO 10993-17.
What we delivered
Lucideon provided a comprehensive solution aligned with ISO 10993 standards, combining technical rigor with regulatory compliance.
Our experts executed ISO 10993-12 extraction protocols tailored to the specific materials of the devices. For ISO 10993-18 chemical characterization, we implemented a multi-technique analytical program. The Analytical Evaluation Threshold (AET) was calculated based on toxicological thresholds and device-specific exposure assumptions, and identification confidence was documented using a tiered approach.
Finally, Lucideon coordinated a toxicological risk assessment through a trusted partner laboratory. This assessment integrated analytical findings into a biological safety evaluation aligned with ISO 10993-17 and MDR requirements. It included hazard identification, dose-response analysis, margin of safety calculations, and consideration of cumulative exposure across multiple extraction conditions.
Value to the client
Lucideon's testing and risk assessment closed critical MDR compliance gaps, enabling the client to proceed confidently with regulatory submissions for their entire device family. By applying appropriate extraction science and rigorous analytical techniques, we ensured accurate characterisation of metals, polymers, and ceramics without introducing false negatives or positives.
The client received a complete, audit-ready documentation package, including extraction protocols, analytical data, AET calculations, and toxicological risk assessments. This streamlined process accelerated time to submission and provided a robust foundation for future lifecycle updates.