Comments on Benefit-Risk of Phthalates in Medical Devices Sought by EC

Comments are sought by the Scientific Committee on Health, Environmental and Emerging Risks on an update of the European Commission guidelines on the presence of phthalates in medical devices.

The guidelines describe how to perform a benefit-risk assessment and/or to justify the presence of carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting phthalates in medical devices.

The guidelines are intended to be used by manufacturers, notified bodies and regulatory bodies.

A public hearing will be held on the guidelines on April 11 in Brussels. Comments will be accepted until April 28.

Read the guidelines here.

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