Authors: Lina Burman and Monica Grekula
In our recent article, we announced the upcoming publication of ISO 10993-1:2025 and explored the technical changes manufacturers will face. For those who've been following the EU MDR requirements, you may already be ahead of the curve. Here's why—and what to do next.
Editor's note: ISO 10993-1:2025 was published on 18 November 2025
The EU Medical Device Regulation 2017/745 (MDR) has given many of us some extra grey hair. Accommodating those challenges now prove advantageous for those who needed to follow it.
After the current version of ISO 10993-1 was published in 2018, the EU MDR has been taken into force. The MDR has forced companies entering the European market to further adapt to a risk-based philosophy inclusive of biocompatibility. The MDR highlights several product specific risks in its "General Safety and Performance Requirements" (GSPR), risks that are less clearly addressed in ISO 10993-1:2018.
Now not thinking of the requirement GSPR 10.4.1 regarding presence of carcinogenic, mutagenic or toxic to reproduction (CMR) and endocrine-disrupting (ED) substances. It is of discussable relevance for safety in many cases. Rather, that it specify product specific hazards and hazardous situations to consider during the total life cycle, such as; fluctuations of temperature and humidity during transport or storage, and compatibility with not only the patient's body but also materials of other parts of device, substances, gases, and medicinal products that they get into contact with during their intended use. The MDR further highlights the importance of risk assessment early, including biological safety, in requirement on elimination or reduction of risks as far as possible through safe design and manufacture.
For all who are already following a risk-based approach, in the EU and globally, ISO 10993-1:2025 represents refinement, not revolution. Others face a steeper learning curve. The shift from prescriptive requirements to risk-based justification demands new competencies, new processes, and most importantly, new ways of thinking.
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If you have not already changed approach, the following fundamental shifts for ISO 10993-1:2025 compliance are recommended for success:
Build biological risk assessment expertise. If you're hiring biocompatibility expertise, prioritize candidates with MDR experience. They should already have made this transition in mindset and can guide your organization through biological safety assessments. For early-stage companies, your first hire or consultant should understand both FDA and MDR requirements to ensure global compliance from the start.
Start early, think holistically. Biocompatibility considerations should be integrated with material selection from the beginning. All biocompatibility tests need to be performed on final finished devices or equivalent, thus often at the end of development. However, early risk-based assessments may identify biological risks during material selection that can be avoided or mitigated, reducing risk of late surprises and delays in projects —unlike the checkbox approach that often postpones biological safety considerations to the final verification stage. Finding out that the material consists of a substance that might bioaccumulate might put your device into the long-term contact category.
Document your biological safety rationale, not just your test results. The new standard demands justification for every decision in your evaluation. Why did you choose these materials from a biological safety perspective? Why should these biological tests be performed? Why isn't additional biological testing necessary? Your scientific rationale for biological safety becomes as important as your test results.
The message is clear: once again, the standard developers try to get biocompatibility testing to become strategic rather than procedural. Each test must have a scientific rationale tied to identified biological risks, not simply a position in a check box list.
Instead of defaulting to biological tests, you should always first conduct thorough chemical characterization, starting with chemical information, and when needed, chemical analyses. If toxicological risk assessment shows no compounds at levels of toxicological concern, certain biological tests, e.g. systemic toxicity, genotoxicity, and carcinogenicity, can be waived.
Material History: Well-established materials with extensive clinical history may require minimal additional biocompatibility testing. However, only if you can document their safe use in similar applications. New applications of existing materials may include new risks that need to be properly evaluated, and data gaps may need to be mitigated by testing.
The standard's writing group has identified several areas requiring additional guidance, including lifecycle assessment, bioaccumulation considerations, risk estimation, literature review processes, and biological equivalence. These clarifications are currently under development and will provide further support as the industry transitions to the revised standard.
In a near-future article, we'll provide a framework of essential questions that will help you move from checkbox thinking to true risk-based assessment.
We are happy to assist you if you are in need of knowledgeable evaluators for fulfillment 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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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.