Medical Devices – Latest Updates

Trends in Biological Evaluations

New Draft Version of EN ISO 10993-1
27 June 2024

The general Standard ISO 10993-1 for the biological evaluation of medical devices is under revision. The current draft version of ISO 10993-1:2024 includes several amendments that manufacturers must take into account in the future:

  1. Changes in wording and corresponding definitions
  2. Introduction of an additional section on the specific requirements to cover the complete life cycle
  3. New section on animal welfare, prescribing that physical and chemical characterisation as well as alternative in-vitro and in-silico techniques must be applied first and prohibiting animal tests in case bioequivalent products exist
  4. New section on biological equivalence
  5. Revised definitions of the contact duration categories (intermittent contact)
  6. Changes to reduce and simplify device contact categories
  7. Consideration of genotoxicity and carcinogenicity for certain contact categories to be extended to additional contact times than previously required
  8. New annexes on material selection and characterisation, key changes in the biological effects, and possible approaches to biological risk estimation
  9. Clarification requiring authors and principal contributors of biological evaluations to add their credentials
  10. Addition of Annex ZA to support harmonisation in the EU in connection with MDR (EU) 2017/745.


In addition, the sections on the endpoints (now “biological effects”) to be addressed, the guidance on how to conduct biological evaluation within a risk management process as well as the requirements for the biological evaluation plan (BEP) have been completely rewritten and moved from the Annex to the normative text to emphasise their importance.

Since the new standard is still in draft state, comments are welcome. Please contact our experts to get more information on how to implement the proposed changes for the future standard in your biological evaluation plans and reports.

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