Europe – European Commission proposes updates to medical device phthalates guidelines

The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019.

The proposed update was published on 21 March by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The guidelines must be updated every five years under the EU Medical Devices Regulation (MDR). (RELATED: EU Drafts Guidance on Assessing the Benefits and Risks of PhthalatesRegulatory Focus 28 March 2019)

“Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED),” the Commission said…