Author

Flore Delaygue, PhD, Consultant - Biological Evaluation Senior Medical Device Consultant
Anja Friedrich, CEO Eurofins Medical Device Testing France 

Body

As the regulatory landscape for dental medical devices continues to evolve, manufacturers across Europe face new expectations to ensure the safety and biological performance of their products. Two major standards, ISO 10993‑1 and ISO 7405, were updated in 2025, introducing important changes that directly impact biological evaluation strategies for dental applications. 

ISO 10993‑1:2025 brings a stronger emphasis on the categorisation of medical devices, integrating new parameters such as reasonably foreseeable misuse, updated exposure duration calculations (now based on contact days), and refined considerations about target populations and contact sites. The revised standard also formally requires biological risk estimation, combining severity and probability assessments for potential biological harms. This step is now essential for producing a compliant Biological Evaluation Plan (BEP). 

Meanwhile, ISO 7405:2025, dedicated specifically to dental medical devices, introduces harmonised criteria for the agar diffusion test, a new informative annex recommending the ARE (Antioxidant Response Element) assay to detect oxidative stress, and additional guidance supporting stepwise toxicological assessment and Margin of Safety (MoS) calculations aligned with ISO 10993‑17. Although these updates do not mandate immediate retesting, ensuring alignment with current requirements is crucial for maintaining regulatory compliance. 

For manufacturers, the path forward depends on the device lifecycle stage: 

• New devices: develop biological evaluations aligned with the updated standards.  
• Legacy devices: perform documentation reviews and gap analyses.  
• Design or material changes: reassess compliance or conduct new testing. 
   

The updates also highlight specific considerations for dental materials, including in‑situ polymerisation, substance‑based components, degradable materials, and wear debris generation, each requiring tailored testing strategies. 

Finally, the U.S. FDA continues to recognise ISO 7405 and has reinforced the importance of Chemical Characterization (CC) as a foundation for reducing animal studies.
With these regulatory evolutions, now is the ideal time for manufacturers to revisit their biological evaluation frameworks and ensure their documentation reflects the latest standards.

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