Guidelines on phthalates in medical devices finalised

In 2019, the independent scientific committee SCHEER published the Guidelines on the benefit-risk assessment of the presence in certain medical devices of phthalates. The guidance document addresses phthalates with one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR), or endocrine-disrupting (ED).

Manufacturers, notified bodies, and regulatory bodies can follow these guidelines to justify the use of CMR/ED phthalates above a concentration of 0.1% w/w in a medical device  – as regulated by the EU MDR (Annex I section 10.4.1.).

The document presents the framework for benefit-risk assessment (BRA), assessment of possible alternatives, justification for the use of CMR/ED phthalate, benefit assessment (material, clinical benefits), methodologies for benefit-risk assessment, uncertainty analysis, and conclusions.

In its conclusions, the SCHEER points out that in view of the concern over the CMR/ED properties of phthalates, further research to replace these phthalates in medical devices is highly encouraged. Different BRA methodologies are theoretically available. Nevertheless, there is a considerable lack of data for potential relevant alternatives to be used in medical devices.

Consequently, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices. As the BRA of the presence of phthalates may have an impact on the conclusions of the “overall” benefit-risk determination of the medical device, a periodic update of the BRA of the medical device may be needed.

2024 updated guidelines on of phthalates in certain medical devices

In June 2024, the SCHEER guidelines underwent their first revision in five years. Comprehensive literary research and extensive feedback led to this update.

Key changes include:

• Scope: Addition of application information of the guidelines.
• Introduction: Update of chemical descriptions of phthalates as esters of phthalic acid and recent regulatory developments.
• Methods: Inclusion of a section detailing the sources of evidence used and the Weight of Evidence (WoE) approach adopted by SCHEER, based on recent literature.
• Framework: Revision of the evaluation process for non-phthalate alternatives, changing “potential relevant” candidates to “most relevant” candidates to focus on the most suitable alternatives. Inclusion of additional information referencing (EN) ISO 10993-18.
• Regulatory information: Incorporation of new details on ED hazard classification, distinguishing between Category 1 (known or presumed endocrine disruptors) and Category 2 (suspected endocrine disruptors) for both human health and the environment.
• Annexes: Inclusion of three new annexes: Annex 8 (exposure to current CMR/ED phthalate alternatives), Annex 9 (health hazards of current CMR/ED phthalate alternatives), and Annex 10 (progress in developing CMR/ED phthalate alternatives for blood bags).

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