The EU has tightened restrictions on carcinogenic, mutagenic and reprotoxic (CMR) substances used in medical devices. Manufacturers will need to reassess their materials and justify every use of high-risk chemicals. Find out how the new regulation impacts MDR compliance and technical documentation.

On 11 August 2025, the Official Journal of the EU published Commission Regulation (EU) 2025/1731, amending the REACH Regulation (EC) No. 1907/2006 to extend restrictions on the use of CMR substances – carcinogenic, mutagenic, and reprotoxic. This legislative change is part of the Union’s broader strategy to phase out the most hazardous chemicals from consumer and healthcare products.

Why CMR matters in medical devices

CMR substances carry risks of cancer induction, genetic mutations, and negative impacts on fertility or fetal development. In medical devices with direct or long-term contact with the human body (implants, contact lenses, surgical materials), exposure pathways can be critical. Under MDR (EU) 2017/745, manufacturers must demonstrate that the use of such substances is technically unavoidable and that all associated risks have been reduced as far as possible.

Key changes introduced by Regulation 2025/1731

  • Broader list of restricted substances: additional CMR entries and clarified scope for specific device categories.
  • Stricter labelling requirements: IFU and labelling must clearly state CMR presence, risk mitigation, and safety conditions.
  • Transitional devices covered: even legacy devices under MDR Article 120 must be reassessed for CMR content.

Consequences for manufacturers

To remain compliant, manufacturers are required to:

  1. Update risk management files (ISO 14971) to include toxicological risk assessments.
  2. Conduct alternatives analysis: prove the absence of safer substitutes or technical infeasibility of replacement.
  3. Align clinical evaluation with MDR Annex XIV to show that benefits outweigh risks.
  4. Revise labelling and IFU to transparently inform about CMR.
  5. Strengthen PMS/PMCF with indicators focused on potential long-term toxicological effects.

Implementation strategies

  • Material mapping of all patient-contacting components.
  • Toxicological risk assessment (TRA) including tolerable daily intakes, exposure scenarios, and safety margins.
  • Change control: significant material modifications may require NB re-approval.
  • Supplier engagement: updated declarations of conformity and test reports.

Summary

Although the transition will increase documentation and testing burdens in the short term, in the long run it will improve patient safety and reinforce trust in the EU MedTech market. Companies that proactively adapt will secure stronger regulatory positions and smoother interactions with Notified Bodies.