Medical Devices:
ISO 10993-1:2025 finally released, 6th edition of the standard on Biological risk evaluation
The 2025 revision of ISO 10993-1 introduces substantial changes to how the biological safety of medical devices must be assessed, shifting decisively toward a risk-based, ISO 14971–aligned approach.
What has changed now?
- Instead of relying on preset tables, manufacturers must now perform a structured biological risk assessment, identifying hazards, estimating risks, and justifying how they are controlled. The evaluation must integrate chemical, physical and biological information before deciding on any testing needs.
- Device categorization is now based strictly on tissue contact type (e.g., skin, mucosa, blood) and exposure duration expressed in cumulative contact days. Repeated or intermittent use contributes to total exposure and may trigger requirements for prolonged or long-term assessment.
- Comprehensive chemical and material characterisation becomes even more essential. These data form the foundation for determining whether biocompatibility testing is required or can be waived through a weight-of-evidence argument.
- Devices with prolonged or long-term contact, except those limited to intact skin, may now require genotoxicity assessments, even when previously not mandatory, as expectations are stricter.
- Where materials or devices are demonstrably similar to existing, safe comparators, manufacturers may justify reduced testing. However, the new standard demands a much more robust demonstration of equivalence.
What should manufacturers do now?
- Update Biological Evaluation Plans (BEP) and Reports (BER).
- Recalculate exposure using the new “contact days” logic.
- Ensure chemical/material characterisation is complete and current.
- Reassess legacy devices under the new framework.
- Use equivalence only when strongly supported by data.
Source: https://www.iso.org/standard/10993-1
The first four modules of EUDAMED have been officially published on November 27, 2025
EUDAMED consists of six interconnected modules, whereas the recently published four modules will become mandatory on May 28, 2026.
What are the four modules about?
- The registration of economic operators.
- The UDI database and the electronic system for device registration.
- Notified bodies and certificates.
- Market surveillance.
What are the main concerns of the new modules?
- Mandatory use of EUDAMED is no longer tied to the full functionality of the entire platform, but to each individual module.
- The UDI database and device registration module require significant resources and planning. The requirements to register may vary based on device status (Legacy/New) and market placement timing.
- EUDAMED lacks an easily accessible bulk upload system, resulting in registration process being particularly demanding in terms of time and resources.
Despite the high level of automation, the process always includes a human consistency check: a detailed analysis to ensure that the submitted data complies with current regulations and with the rules governing the creation and assignment of UDI codes.
Source: https://ec.europa.eu/tools/four-first-modules
REACH:
Consultations Open on Chromium Trioxide Uses
ECHA has launched a new consultation on five applications for authorization concerning five specific uses of chromium trioxide (EC 215-607-8).
The applications relate to the continued use in functional chrome plating, an area where chromium (VI) substances remain critical for achieving specific technical performance, despite their well-known hazardous properties.
What is the scope of the Consultation?
On ECHA’s website you can find detailed descriptions of each of the uses applied for, giving stakeholders the background they need to comment on the applications.
The consultation seeks scientific, technical and socio-economic information that may assist ECHA’s Committees for Risk Assessment and Socio-Economic Analysis to form their opinions.
When is the deadline?
Interested parties (including industry, NGOs, researchers and authorities) should be submitted comments using ECHA’s online web form before January 7, 2026.
This process forms part of the authorization framework under REACH, ensuring that chromium trioxide can only be used when risks are properly controlled and no suitable alternatives are available.
Source: Applications for authorization – current consultations
ECHA:
ECHA Recommends Adding Four Substances to REACH Authorization List
ECHA has recommended to the European Commission that four substances, including Melamine, should be added to the REACH Authorization List to offer additional protection for human health and the environment.
Once these substances are listed, companies seeking to continue using them must submit authorization applications, demonstrating their uses are safe or that socio-economic benefits outweigh the risks.
The proposed addition underlines the continued commitment of ECHA to ensure high-risk substances are appropriately controlled under the REACH framework. In recommending the shift of substances from registration to authorization, the agency reinforces oversight and paves the way for increased regulatory scrutiny of their future uses.
The broad framework further helps users through the complicated regulatory landscape that also references previously repealed legislations.
Source: ECHA
CLP:
New Consultations, Intentions and Proposals on Harmonized Classification and Labelling
ECHA has opened a new round of consultations on proposed harmonized classifications under the CLP Regulation. The agency is currently seeking comments on the classification proposals for:
- sodium fluoride (EC 231-667-8, CAS 7681-49-4)
- quizalofop-P-ethyl (ISO); ethyl (2R)-2-{4-[(6-chloroquinoxalin-2-yl)oxy]phenoxy}propanoate (EC -, CAS 100646-51-3)
- trimethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex (EC -, CAS -).
Comments are due by 16 January 2026. These consultations provide an opportunity for authorities, industry and other interested parties to provide scientific and technical information likely to be used in the final decision-making process.
Meanwhile, ECHA has issued a new intention to harmonize the classification and labelling of cyantraniliprole, although identifiers remain to be determined. This initiates the preparatory phase prior to a full CLH dossier being submitted.
The agency has also received a new formal proposal for harmonized classification for the substance 2-[2-(7,8-difluoro-2-methylquinolin-3-yloxy)-6-fluorophenyl] propan-2-ol, for which the official EC and CAS numbers will be confirmed. This proposal will undergo scientific evaluation by RAC, followed by public consultation.
These steps form part of the continuous update cycle of Annex VI to CLP, by which substances placed on the EU market are assessed according to up-to-date hazard information and scientific evidence.
Sources: ECHA
