For manufacturers of implantable medical devices, ensuring long-term biocompatibility is critical. Not solely for regulatory compliance, but for the safety and wellbeing of the patients who rely on life-changing or life-saving technologies. However, knowing when and how to conduct implantation testing, or which regulations apply, can present a challenge. Without the right support, you may face delays, repeat studies, or insufficient data that could jeopardise your approval timeline. 

Eurofins Medical Device Services network of laboratories offers implantation testing in accordance with ISO 10993-6, providing you with clarity, compliance, and confidence at every stage. Whether your device is temporary, long-term, or permanent, our in vivo studies evaluate the local effects of implants on surrounding living tissue at both the macroscopic and microscopic level, with an approach that includes: 

• Subcutaneous and Intramuscular Implantation
• Histopathological Evaluation of implant site tissue
• Quantitative and Qualitative Scoring of cellular responses
• Intraperitoneal Implantation where required by regulatory context 
• Compliance With ISO 10993-6 and global regulatory expectations 

All implantable devices that contact internal tissue, bone, or cavities – especially Class B or Class C products and those in contact with blood – must undergo implantation testing.

These studies identify toxicological responses such as inflammation, necrosis, or fibrosis that may otherwise go undetected in short-term assessments. Because these reactions can begin at the cellular level, our experts use detailed histopathology to study structural changes to tissue and cell morphology. 

Whether your product is a spinal cage, vascular implant, joint prosthesis, or orthopaedic plate, we simulate real-use conditions to deliver meaningful results. Our testing includes implantation durations tailored to device contact time. 

• Class A: less than 24 hours 
• Class B: 24 hours to 30 days 
• Class C: more than 30 days 

Where necessary, we can extend observation periods to evaluate longer-term effects, per FDA and international guidance. Every study is supported by rigorous sample preparation. Devices undergo the same manufacturing, sterilisation, and packaging processes as the final product, ensuring that testing reflects clinical reality. We also offer integrated toxicological risk assessment and complementary testing services such as extractables and leachables analysis to provide a complete picture of implant safety.

From protocol development to final reporting, we provide end-to-end support tailored to your device, materials, and regulatory pathway. 

At Eurofins Medical Device Services, implantation testing is just one of the ways we help ensure the safety of critical devices and the patients who depend on them.