Biocompatibility Testing & Post-Market Surveillance for Medical Devices: A Must-Read Guide for Manufacturers

Ensuring patient safety doesn’t end with regulatory approval—it continues throughout the entire lifecycle of your device. For medical device manufacturers, two pillars of compliance and safety stand out: biocompatibility testing and post-market surveillance (PMS).

This blog will guide you through the essentials of both, based on official global regulatory guidance from FDA, WHO, and MHRA, as well as international standards like ISO 10993, ISO 13485, and ISO 14971.

What Is Biocompatibility Testing—and Why It Matters

Biocompatibility testing ensures that a medical device is safe and compatible with the human body. Regulators require manufacturers to evaluate potential toxic, immunologic, or carcinogenic risks before devices reach the market.

• FDA Guidance: The U.S. FDA endorses ISO 10993-1 for biological evaluation of medical devices and recommends a risk-based approach to testing .
• ISO Standards: The ISO 10993 series defines biological evaluation processes covering cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and long-term implantation effects.

Navigating Biocompatibility Requirements: ISO & FDA Pathways

• ISO 10993-1: Establishes a risk management framework for evaluating device materials and exposure duration.
• FDA Requirements: FDA’s premarket submissions often require data from ISO 10993 testing, chemical analysis, and toxicological risk assessments. Draft guidance (2024) also highlights chemical characterization as a critical step in biocompatibility.

Post-Market Surveillance (PMS): Safeguarding Patient Safety

Regulatory approval is not the finish line—it’s the beginning of continuous monitoring. PMS ensures medical devices remain safe and effective in real-world use.

• WHO Guidance: PMS involves feedback collection, adverse event reporting, corrective/preventive actions, and ongoing performance evaluation .
• Key Manufacturer Duties:

• 1. Collect user and clinical feedback
  2. Record and investigate incidents
  3. Implement corrective actions
  4. Update risk and clinical evaluation documentation

Regulatory Perspectives: UK & Global Alignment

In Great Britain, the MHRA mandates manufacturers to implement PMS plans as part of device safety and compliance obligations.

Across markets, PMS is harmonized with:

• ISO 13485: Quality management systems for medical devices
• ISO 14971: Risk management throughout the device lifecycle

Best Practices for Manufacturers

1. Plan Biocompatibility Early: Select safe materials and use a risk-based evaluation instead of a “test-everything” approach.
2. Integrate PMS with QMS: Use ISO 13485 frameworks to ensure findings feed into quality and safety improvements.
3. Leverage PMS Data: Update risk assessments, design files, and clinical evaluations with real-world evidence.
4. Stay Aligned Globally: Monitor updates from FDA, WHO, MHRA, and ISO for evolving expectations.

Contact our experts at Titans Medical Consulting today to streamline your compliance journey and safeguard your devices’ success in global markets.