Anticipating Regulatory Developments and Managing Specific Molecules

Medical Devices Anticipating Regulatory Developments and Managing Specific Molecules

2025-11-24 From Sebastien Paillard, Astrid Robert and Marilys Blanchy 2 min Reading Time

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The requirements applicable to medical devices are evolving at a fast pace under the combined influence of European standards and regulations. Several regulations are necessary to be followed when using chemicals and substances among others, we can cite the regulation about Classification, Labelling and Packaging of substances and mixtures (reg 2024/2865), also known as CLP.

Collection of manufacturing data and analysis of chemical compositions (SDS).(Source: Applus+ Laboratories) — Collection of manufacturing data and analysis of chemical compositions (SDS).
(Source: Applus+ Laboratories)

The CLP Regulation requires manufacturers, importers and downstream users of substances and mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market or the regulation Reach (Regulation 1907/2006) which control the use of substances in the European Union regulation. The CLP regulation has been revised and introduces new hazard classes, especially for endocrine disruptors as well as for PBT/vPvB and PMT/vPvM substances, profoundly changing the prioritisation of substances to be monitored (risk assessment).

In parallel, Reach is tightening its restrictions: Regulation (EU) 2024/1328 imposes severe limitations on cyclic siloxanes D4, D5, and D6, with specific deadlines for medical devices. The microplastics restriction (2023/2055) imposes reporting obligations starting in 2025. The European Chemicals Agency (ECHA) has published an updated proposal on 27 of august 2025 to restrict per- and polyfluoroalkyl substances (PFAS) under the EU’s chemicals regulation Reach, including 8 more sectors, among them medical applications.

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