Top 5 Questions About ISO 10993-1:2025

The new edition of ISO 10993-1:2025 Biological evaluation of medical devices, Part 1, Requirements and general principles for the evaluation of biological safety within a risk management process ↗ has now been published. This update reshapes how biological safety should be approached, documented, and justified throughout a device’s lifecycle.

As expected, the publication has raised several important questions across the industry.

1. What exactly are the new requirements, and how should they be applied?

Manufacturers want clarity on how the revised framework affects their current practices. The updated version strengthens the link between biological evaluation and the overall risk management process, places more emphasis on justification in place of testing where appropriate, and introduces more detailed expectations for material characterization and toxicological assessment. Understanding how these elements work together is essential for building a compliant and well supported approach.

• 2. How do we update existing biological evaluations to meet the new standard?

• Many organizations now face the task of revisiting their biological evaluation reports. This involves verifying whether the current documentation has enough scientific rationale, ensuring that data gaps are properly addressed, and checking that decisions align with the structure of the updated standard. In many cases, a targeted gap assessment will help determine whether only small updates are needed or whether a more extensive rewrite is required.

• 3. Will legacy devices need to be retested?

• Manufacturers are considering the impact on devices that have been on the market for several years. Retesting is not automatically required, however the revised standard raises expectations for justification and evidence. As a result, some legacy files may need updated scientific reasoning or additional data to support continued compliance. Addressing this early can help prevent delays in audits or regulatory submissions.

• 4. Will all countries adopt the changes in the same way?

• Regulatory expectations differ across markets, and adoption timelines will vary. Some authorities align quickly with the newest edition while others continue referencing older versions for longer. Understanding these differences is important for companies placing devices in several regions, especially when planning updates across global portfolios.

• 5. How long is the transition period, and what steps should we take now?

• Transition periods influence project planning and submission strategies. Manufacturers should begin by reviewing the revised requirements, mapping potential gaps, and prioritizing devices that are higher risk or approaching regulatory deadlines. Acting early helps avoid compliance issues once authorities start fully referencing the new edition.

• How Qserve Can Assist

Our two-hour e-learning training provides clear and practical guidance on these topics. Whether you are new to ISO 10993-1 or familiar with the 2018 version, the course will help you:

• Navigate the updated version with a structured walkthrough,
• Understand the most significant changes compared to the previous edition,
• Gain insight into how global regulators may interpret and implement the revision,
• Build confidence in managing the transition.