Titanium Dioxide and MDR/IVDR: Clarification Following the CJEU Judgment – What Manufacturers Need to Know

With its judgment of 1 August 2025, the Court of Justice of the European Union dismissed the appeals against the judgment of the General Court of 23 November 2022. As a result, the partial annulment of Delegated Regulation (EU) 2020/217 concerning the harmonised classification and labelling of titanium dioxide remains in force.

Specifically, this means that titanium dioxide in powder form containing at least 1% of particles with an aerodynamic diameter ≤ 10 µm is no longer harmonised as a Category 2 carcinogenic substance by inhalation. The corresponding entry in Annex III of the CLP Regulation, as well as the associated annexes and notes, has been declared invalid. An EU-wide harmonised CMR classification of titanium dioxide therefore no longer exists at present.

 

Implications for Medical Device and IVD Manufacturers

For manufacturers of medical devices and in vitro diagnostic medical devices, this decision provides important regulatory clarification. The former classification had led to uncertainties, particularly in connection with Annex I, Chapter II, Section 10.4 of the MDR, which provides for specific requirements for products containing CMR substances.

With the removal of the harmonised classification, titanium dioxide is no longer automatically assigned to CMR substances in regulatory terms.

 

What Remains Required
Irrespective of the CLP classification, manufacturers remain obliged to carry out a product-specific risk assessment and biological evaluation. The decisive factors continue to be:
  • the route of exposure (e.g. inhalation versus implantation),
  • the potential for particle release,
  • the duration of use and the intended purpose of the product.
This is particularly relevant for products where powders, aerosols or abrasion may occur. For many applications – such as titanium dioxide firmly embedded as a pigment in plastics or implants – no additional safety-relevant impact generally arises.

 

Recommendation for Manufacturers
Manufacturers should assess whether:
  • existing risk management and biological evaluations are based on the former CMR classification,
  • the relevant sections should be updated or clarified,
  • a clear line of argumentation towards Notified Bodies is required.
A sound, scientifically substantiated assessment remains the central benchmark.
We support you in the regulatory classification of this decision, the updating of your technical documentation, and the strategic communication with Notified Bodies and authorities.

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