Biocompatibility – The Unseen Backbone of Medical Device Safety

🔬 Biocompatibility – The Unseen Backbone of Medical Device Safety 🌍
Whether you’re pursuing regulatory approval in the United States (US FDA) or the European Union (CE marking), biocompatibility testing is a non-negotiable requirement for medical devices that come into direct or indirect contact with the human body.
At D2R Global Consulting, we help device manufacturers navigate the complexities of international biocompatibility standards to ensure both compliance and patient safety.

🧪 Key Regulatory Frameworks
US FDA (21 CFR Part 820 / ISO 10993)
Follows ISO 10993-1 guidelines for biocompatibility evaluations
Requires a risk-based biological evaluation tailored to the device’s contact type and duration
Preclinical data must align with expectations in the FDA guidance on ISO 10993-1 (2020 revision)

CE Marking (MDR 2017/745 / ISO 10993)
Demands biological safety evaluations as part of the General Safety and Performance Requirements (GSPR)
Biocompatibility is evaluated within the technical documentation and clinical evaluation report (CER)
Emphasis on chemical characterization and justification of test omission, if applicable

✅ Core Testing Parameters (based on ISO 10993 series):
Cytotoxicity
Sensitization
Irritation/Intracutaneous reactivity
Systemic toxicity (acute, subacute, chronic)
Genotoxicity
Implantation
Hemocompatibility (for blood-contacting devices)

💡 Pro Tip from D2R:
A biological risk assessment can often replace some traditional tests if sufficient chemical characterization and justification are provided. Don’t test blindly—test smart.

🚀 Ready to launch your device globally?
Let D2R Global Consulting help you build a compliant, cost-effective biocompatibility strategy that meets both FDA and CE expectations without delays.