Biocompatibility in Medical Devices: Ensuring Safety, Compliance, and Market Success

Why Biocompatibility Matters in Medical Devices

In medical devices, innovation often takes the spotlight. Shiny new materials, novel coatings, and futuristic 3D-printed structures attract attention. But behind every device that actually reaches patients lies an unsung hero: biocompatibility. 

It may not sound glamorous, but biocompatibility is one of the key factors determining whether a device is approved, remains on the market, and reaches the people who need it. And here’s the catch: biocompatibility is never “done”. If not kept up to date, it can stop a device at regulatory borders,  literally and figuratively. 

What Biocompatibility Really Means 

At its core, biocompatibility is about safety. It is the ability of a material or device to perform its function in contact with the human body without causing toxicity, inflammation, or long-term harm. 

Think of it as a passport. Without proof of biocompatibility, regulators will not let a product cross into new markets. Even in approved regions, outdated or incomplete data can trigger audits, delays, or recalls. 

ISO 10993 and ISO 14971: Building Blocks of Safety and Compliance 

Biocompatibility is guided by internationally recognised standards. ISO 10993 establishes the framework for biological evaluation of medical devices, defining principles for test selection, data interpretation, and ensuring materials in contact with the body are safe. 

ISO 14971 complements it by setting the foundation for risk management. It requires manufacturers to identify hazards, including biological risks, evaluate them, and implement controls throughout the product lifecycle. 

Together, these two standards represent essential references for regulatory acceptance worldwide. Still, they are not the only ones. The ISO 10993 series itself span multiple parts that address different contexts, such as short- versus long-term patient contact, implantable versus external devices, and specific material considerations. Other standards and guidance may apply to coatings, surface treatments like anodisation, or particular device categories, depending on regulatory expectations. 

The 2025 Update to ISO 10993: What’s Changing and Why it Matters 

Biocompatibility requirements evolve as science and standards advance. The ISO 10993 series, which already covers topics ranging from cytotoxicity testing to long-term implantation, is being revised, with a new version expected in 2025. 

The update reinforces the risk-based approach, moving away from a checklist mindset. Manufacturers will be expected to justify their strategy according to device type, composition, duration of contact, and any surface modifications. The revision also places greater weight on chemical characterisation, supported by advances in analytical chemistry that detect even trace levels of leachables and extractables. This reduces reliance on animal testing while improving predictive value. 

Another focus is closer alignment with regulations such as the European MDR and FDA guidance, making documentation more transferable across jurisdictions. Most importantly, the revision underscores that biocompatibility is a living obligation. Data must be reviewed and updated regularly, especially when materials, suppliers, or processes change. 

For manufacturers, the update offers both opportunities and responsibilities: more efficient strategies with less redundant testing, but also the need to ensure documentation reflects the latest version of the standard and current scientific knowledge. Outdated reports will no longer suffice. 

A Global Issue: Europe, Brazil, and Beyond 

Biocompatibility is not just a European or U.S. requirement. In the European Union, the Medical Device Regulation (MDR) treats it as an ongoing obligation, requiring continuous updates and evidence that devices remain safe. 

In Brazil, ANVISA does not explicitly reference ISO standards in its regulations but accepts biological evaluation reports and plans prepared under the ISO 10993 framework, which has become the industry norm. Biological evaluation is a critical element in the registration of medical devices and applies even to those marketed under a notification regime rather than full registration. In practice, this means that devices of lower classification must also demonstrate biological safety through appropriate evaluation. 

In the United States, the FDA explicitly references ISO 10993 in its guidance. Across Asia, regulators are increasingly aligning with international frameworks, though local requirements still exist. 

Whether the market is São Paulo, Stuttgart, or San Francisco, the message is clear: without solid biocompatibility evidence, devices cannot advance with confidence or achieve sustainable market access. 

Real-World Biocompatibility Challenges and Solutions

In my work supporting clients with biological evaluation strategies, I have seen how biocompatibility is not always straightforward. Even when a device appears safe, deeper investigation can reveal unexpected risks. 

One case involved a reverse osmosis system for dialysis water treatment. The device itself had no direct contact with the patient, and all hydraulic materials were compatible. However, a cleaning agent used in the process raised concerns. Although no complaints had been reported, a literature review uncovered several articles describing severe patient harm linked to residual levels of that cleaning agent in dialysis water. This case showed how essential literature review is. Even when testing and post-market feedback suggest safety, published data can reveal risks that routine evaluations miss. 

Another case highlighted the importance of selecting a comparable device when direct biocompatibility testing is not feasible. For financial or logistical reasons, some manufacturers cannot generate new data on their own products. In such cases, ISO 10993-18, Annex C, provides guidance for establishing equivalence with a comparator. Choosing the right device strengthens the evaluation and satisfies regulators when in-house data is limited. But this only works if the comparator is chosen with rigorous criteria and justified clearly. 

These experiences reinforced a key message: biological evaluation is not just about running tests. It requires a holistic strategy combining laboratory data, literature evidence, and, when necessary, equivalence assessments to present a complete and reliable picture of patient safety. 

The Pitfalls of Ignoring Updates 

Keeping biocompatibility data current can feel like a burden. Testing requires time and investment, and it can delay product launches. But the risks of neglecting updates are far greater. Regulatory authorities may block device registrations, existing approvals can be challenged during audits, and, in the worst cases, patient safety and company reputation may be compromised. 

Manufacturers that treat biocompatibility as an ongoing process, not a one-time task, gain a clear advantage. They avoid regulatory surprises, build stronger trust with authorities, and position themselves for global reach. 

The Future of Biocompatibility 

 The field is evolving quickly. New materials, such as bioresorbable polymers, nanostructured coatings, and 3D-printed scaffolds, are raising new questions and challenging traditional methods. At the same time, alternatives to animal testing are advancing, with in vitro models and computational simulations offering faster, more ethical, and often more predictive insights. 

Manufacturers that adapt to these changes will not only comply with regulations but also lead the way in developing safer, more innovative devices. Those who fail to do so risk being left behind. 

Biocompatibility as the Key to Medical Device Success

Biocompatibility may not be the most glamorous part of medical device development, but it is the foundation of market access and patient trust. Guided by standards like ISO 10993 and ISO 14971, and reinforced by evolving regulations worldwide, it determines whether devices reach patients and remain competitive. At the same time, these standards are part of a broader ecosystem of international norms and guidance that vary depending on device type, material, and intended use. 

The rule is simple: update your biocompatibility or risk your device getting stuck at the border. Companies that treat biocompatibility as a continuous, strategic process will not only achieve compliance but also secure long-term success in a competitive, globalised market.

References

• ISO 10993-1 
• ISO 10993-18 
• ISO 14971 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.