ISO 10993-1:2025 Questions Medical Device Innovators Should Answer

Authors: Lina Burman and Monica Grekula

With ISO 10993-1:2025 shifting the industry away from checkbox compliance toward genuine risk-based thinking, medical device innovators face a fundamental challenge: asking the right questions. This is especially critical for those with limited experience in risk-based analysis. Rather than focusing on device categories and test checklists, start here. 

Editor's note: ISO 10993-1:2025 was formally released on 18 November 2025.  

Essential Questions You Should Answer As ISO 10993-1:2025 Takes Effect

About Your Device's Reality: 

• Are all the effects to be considered actually relevant for your specific device and are all that should be relevant suggested?
• What is the actual exposure scenario for your device?
• Are your materials stable throughout the device's total lifetime? All the way from the factory to being discarded. For example, what happens while your device is waiting to be used (storage, transport)?
• What happens while your device is used by a patient, both during expected and reasonably foreseeable misuse? 

About Potential Hazards: 

• What hazards can your device's materials, manufacturing process, and packaging lead to?
• Can they cause irritation or sensitization?
• Is there direct tissue contact, and if so, any potential concerns considering local tolerance?
• Is there a risk that your device breaks, and in such a case, can users be exposed to internal components (new materials)?
• Is there any reason to expect material degradation or changes over time? 

About Reasonably Foreseeable Misuse: 

• What is "reasonably foreseeable misuse" for your device?
• If clinicians routinely use your 24-hour device for three days, have you evaluated those three days?
• If your adult-indicated device is commonly used in pediatric populations, have you assessed those risks?
• Is it used with other types of patient contact than intended?
• How do you prevent extended use if that creates additional risks? 

These aren't theoretical exercises; they're requirements that connect directly to your ISO 14971 risk management process. 

As the industry awaits additional guidance on topics including lifecycle assessment, bioaccumulation, and biological equivalence, these fundamental questions will remain your foundation for compliant, science-based biocompatibility evaluation. 

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Veranex also provides comprehensive biological safety evaluations and toxicological risk assessments to ensure regulatory compliance and patient safety throughout your product development lifecycle. 

In need of assistance or training? 

We are happy to assist you if you are in need of knowledgeable evaluators for fulfilment of competence requirement, training of your team, or just a second opinion in the transfer to working in accordance with the revised version. Contact us via https://veranex.com/contact/project-request, or send an email to biocompatibility@veranex.com. 

Keep an eye up for the Biocompatibility Insights 2026 conference, a "not-to-be-missed" event. 

Also, if you are interested in discussing biocompatibility related topics, you are welcome to join Veranex complementary discussion forum "Veranex Biocompatibility Coffee breaks". During 45 min sessions, held about once a month, we discuss preset topics with an invited guest. Email us at biocompatibility@veranex.com for a link to all sessions or specific one. 

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About the authors: 

Lina Burman, PhD, is Senior Manager, Biocompatibility and Toxicology at Veranex. She holds a PhD in polymer chemistry with focus on chemical analyses and degradation behavior. She possesses 15+ years working with biological evaluations and toxicological risk assessments of medical devices along with deep expertise in the evaluation of breathing gas pathway devices.

Monica Grekula is Senior Director, Biocompatibility and Toxicology. With 25+ years of experience in the medical device industry, she holds an MSc in Pharmacy and MSc in Applied Toxicology. She is a European-registered Toxicologist and Member of ISO/TC194 since 2006.