EU Launches Public Consultation on Phthalates in Medical Devices

In a significant step towards addressing public health concerns, the European Union, through the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), has opened a public consultation on the preliminary update of the SCHEER guidelines. This initiative focuses on the benefit-risk assessment of the presence of phthalates in certain medical devices, particularly those identified as carcinogenic, mutagenic, toxic to reproduction (CMR), or having endocrine-disrupting (ED) properties.

Consultation Details

Status: Open
Opening Date: 21 March 2024
Deadline: 28 April 2024, 23:59 (CEST)
Target Audience: Public health community

This consultation is crucial for the advancement of safer medical devices and invites input from all relevant stakeholders, including manufacturers, notified bodies, regulatory entities, and the general public.

Objectives and Scope of the Guidelines

The updated guidelines serve a vital role in ensuring the safety and efficacy of medical devices that contain phthalates with CMR or ED properties. Key aspects of the guidelines include:

Evaluation of possible alternatives to phthalates used in medical devices.
Methodology for performing a benefit-risk assessment to justify the presence of CMR/ED phthalates in medical devices.
Support for assessments of other CMR/ED substances in medical devices.

The initiative underscores the EU's commitment to public health and safety by regulating the use of potentially harmful substances in medical devices. By revising the SCHEER guidelines, the European Commission aims to reflect the latest scientific evidence and promote the development and use of safer alternatives.

How to Participate

Stakeholders are encouraged to provide feedback on the preliminary guidelines by submitting written comments through the designated electronic template by the specified deadline. This process allows for a comprehensive review of the scientific basis of the guidelines and identification of areas requiring further investigation.

SCHEER has reiterated the importance of manufacturers generating high-quality data on alternatives to CMR/ED phthalates in medical devices. Such data are crucial for informed decision-making and the development of safer medical products.

Looking Ahead

The feedback obtained from this consultation will play a pivotal role in shaping the final guidelines, ensuring they effectively address the risks associated with phthalates in medical devices. The European Commission's proactive approach, through SCHEER, highlights the ongoing efforts to enhance public health protections within the EU.

This public consultation represents a collaborative effort to refine regulatory standards and promote the safety of medical devices across Europe. Stakeholders are urged to participate actively in this critical consultation process.