The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has been asked by the European Commission (EC) or EU Regulation to update the recommendations for weighing the benefits and risks of the presence of phthalates in certain medical devices. The request targets phthalates that are endocrine-disrupting, carcinogenic, mutagenic, or harmful to reproduction (CMR) by EU Regulation. SCHEER – Mandate Guidelines Phthalates 2024
Scope:
This information request is being made in accordance with the guidelines for stakeholder interaction outlined in the Scientific Committee Rules of Procedure. This information request is intended to make sure that the Scientific Committee has access to all pertinent scientific data for review.
All interested parties are encouraged to provide any pertinent data that can help the scientific committee evaluate and revise the current set of recommendations are
- Knowledge of how to apply the current rules and how frequently they are used
- Important problems arising from the application of the different recommendations stages
- Information on the phthalates currently utilized in medical devices as plasticizers
- Information on biomonitoring and potential patient or user exposure to plasticizers used in medical equipment
- Information about potential compounds, materials, construction methods, or medical procedures already utilized as phthalate substitutes in medical devices
- Information explaining why potential drug and/or material alternatives, if accessible, or design changes, if viable, are unsuitable in light of preserving the product’s functionality, performance, and benefit-risk ratios Vulnerable populations, such as newborns and dialysis patients, should be included in this material.
The subject line of the email should be “Call for Information – update of Guidelines on the benefit-risk Assessment of the Presence of Phthalates in Medical Devices,” and all information should be sent to SANTE-SCHEER@ec.europa.eu in electronic form (readable and copyable).
The information must be submitted before July 17, 2023, 23:59. However, the request for information will continue to be accepted after this time, and if further research is needed, it may be submitted to the working group at a later time. The criteria for the request for information and procedures for submission are listed in a document titled “Guidelines for Submission of Contributions.”
Expand with us:
The latest and most up-to-date medical news from the FDA, TGA, Australia, MHRA, MDA, and other nations is available to subscribers of the Morulaa website. If you need assistance registering a medical device in India or other Southeast Asian nations, please get in touch with us.
Source: Europa. eu
