EU: The European Commission has published guidelines concerning the use of phthalates in medical devices
The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published guidelines concerning the use of phthalates in medical devices.
The guidelines have been drafted and adopted in light of the EU Medical Devices Regulation (MDR) which will be applicable on 26 May 2020 and are intended to be used by manufacturers, notified bodies, and competent authorities.
The guidelines explain that phthalates are widely used in industry and may be released into the environment and into the human body when in contact with medical devices incorporating phthalates. The guidelines provide guidance on when and how to determine whether the use of phthalates can be justified.
The guidelines provide a step by step overview on how to assess the use of phthalates by conducting a risk- benefit assessment. The guidelines describe how to evaluate the possible alternatives for these phthalates used in medical devices. The description includes the evaluation of alternative materials, designs or medical treatments.
The guidelines can be found here: Guidelines on usage of phthalates in the medical devices.
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