Specific Molecule Management in Medical Devices: Regulatory Compliance

Regulatory Framework for Specific Molecule Management

Several frameworks govern the use of chemicals and substances, including:

• CLP Regulation (Regulation 2024/2865): Classification, Labelling and Packaging of substances and mixtures. It requires manufacturers, importers, and downstream users to classify, label, and package hazardous chemicals before placing them on the market.
• REACH Regulation (Regulation 1907/2006): Controls the use of substances within the EU. Recent updates impose severe restrictions on cyclic siloxanes (D4, D5, D6) and introduce reporting obligations for microplastics starting in 2025.
• PFAS Restrictions: The European Chemicals Agency (ECHA) proposed an extended ban on PFAS in August 2025, impacting eight sectors, including medical applications.
• ISO 10993 Revision: Emphasizes chemical profiling and its rationale in biological evaluation, making detailed substance characterization essential.

These changes introduce new hazard classes for endocrine disruptors and PBT/vPvB substances, profoundly altering risk assessment priorities. Together, they call for proactive anticipation: identifying critical molecules, assessing toxicological risks, and documenting compliance in a dynamic regulatory framework.

Why Specific Molecule Management in Medical Devices is Strategic?

Medical devices, due to their diverse materials and processes, can release substances with sensitive regulatory profiles such as siloxanes, PFAS, phthalates, monomer or solvent residues, and certain metallic catalysts. These substances may appear in all types of devices or packaging, from blood bags and catheters to surgical sutures.

Even at trace levels, these molecules can impact:

• Biocompatibility and patient safety
• REACH compliance and CLP labeling obligations
• Environmental impact

How can we optimize the management of specific molecules and ensure compliance?

A combined analytical, toxicological, and regulatory expertise is key. Robust GC-MS and LC-MS analyses, including targeted and non-targeted screenings, help identify regulated families such as PFAS, siloxanes, and phthalates.

Proactive regulatory monitoring, integrating REACH, CLP, MDR, and FDA developments into analytical strategies, enables justification of exemptions and secures compliance plans.

Tangible Added Value for Your Projects

At Applus+ Laboratories, we assist clients in identifying, understanding, and managing chemical substances in correlation with materials, processes, and patient exposure. Our integrated approach:

• Reduces the risk of non-compliance in regulatory submissions
• Improves interpretation of analytical results
• Provides personalized insights on critical substances
• Facilitates decision-making for alternatives or reformulations
• Strengthens MDR and FDA submissions through proactive anticipation

In today’s evolving regulatory environment, managing specific molecules is no longer optional, it’s a strategic necessity. Success requires multidisciplinary expertise spanning formulation, materials science, process engineering, and regulatory affairs. This synergy not only secures compliance but also accelerates time-to-market for innovative medical devices.