The European Commission has requested the Scientific committee* to provide guidelines on the benefit risk-assessment of certain phthalates present in the medical devices that:
• are invasive and come into direct contact with the human body,
• (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
• transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.
“Phthalates are widely used in medical device industry as plasticizers and number of phthalates are suspected of and/or have been classified or identified as having CMR or endocrine-disrupting properties.”
Following Section 10.4. of Annex I to the new MDR, the committee shall issue the requested guidelines until 31 March 2019.