ISO 10993: A strategic approach to the biological evaluation of medical devices
Biological evaluation is a fundamental element in demonstrating the safety of medical devices and compliance with Regulation (EU) 2017/745 (MDR). The ISO 10993 series represents the internationally recognized standard for assessing the biocompatibility of materials and devices throughout their entire lifecycle.
In this context, Kiwa, as a Notified Body, supports manufacturers through a rigorous, scientific, and risk‑based approach, transforming regulatory requirements into a structured pathway that creates tangible value.
Beyond testing: ISO 10993 as a biological risk management process
The evolution of the ISO 10993 series has introduced a paradigm shift—from the simple execution of biological tests to a comprehensive, risk‑based evaluation, as defined in ISO 10993‑1.
Today, biocompatibility assessment requires an integrated analysis of:
- the nature and duration of contact with the human body
- material composition and manufacturing processes
- existing data, scientific literature, and clinical evidence
Kiwa positively evaluates scientifically justified and proportionate approaches that demonstrate a thorough understanding of biological interactions and minimize unnecessary testing, thereby optimizing time and resources.
ISO 10993 and MDR: consistency, integration, continuity
With the application of the MDR, biological evaluation has taken on a central role in demonstrating compliance with the General Safety and Performance Requirements (GSPR).
For Kiwa, consistency is essential across:
- biological evaluation (ISO 10993)
- risk management (ISO 14971)
- clinical evaluation
- up‑to‑date technical documentation
A structured and dynamic approach, also incorporating post‑market surveillance, ensures regulatory continuity and long‑term robustness.
Kiwa: A Notified Body close to manufacturers
In an increasingly complex regulatory landscape, Kiwa supports manufacturers as a competent and reliable partner.
Close collaboration with companies, combined with technical expertise and regulatory clarity, fosters constructive dialogue and a practical understanding of operational challenges.
This approach enables manufacturers to:
- reduce iterations and critical issues
- prevent non‑conformities
- support market access and business continuity
Compliance is not merely a requirement, but a tool to support development, quality, and market confidence.
The value of Kiwa
- Scientific and regulatory expertise
- Risk‑based, lifecycle‑oriented approach
- Continuous dialogue and qualified support
- Focus on effective and sustainable compliance
The ISO 10993 series is today a strategic element in ensuring patient safety and compliance with the MDR.
With Kiwa, biological evaluation becomes an integral part of a robust regulatory strategy; one that transforms compliance into concrete value for manufacturers and for the healthcare system as a whole.
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