As reported in this news column on 1 March 2019, the European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has now published its preliminary report on the benefit risk assessment (BRA) of phthalates in medical devices, following the committee’s September 2017 acceptance of a request from the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. The full title of the document is ‘PRELIMINARY version of the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties’.
The document provides preliminary guidelines on the BRA of the presence in medical devices of phthalates which are currently alleged to have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting.
The guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w). The Medical Devices Regulation (MDR, 2017/745) permits such materials above 0.1% by weight (w/w) only “when justified” (MDR Annex I, Chapter II, point 10.4). Such a justification must be based on an analysis of potential patient and user exposure, availability of possible alternatives, an argumentation why possible alternatives are appropriate or inappropriate, and on the most recent SCHEER guidelines.
The preliminary document also considers the evaluation of possible alternatives for phthalates used in medical devices, and is intended to be used by stakeholders including manufacturers, notified bodies and regulatory agencies. The guideline states that it may also be used for BRAs of other CMR/ED substances in medical devices.
Pending new scientific evidence, the guidelines recommend that their use and usefulness are evaluated after an experience period of three years.
The guidelines offer no new scientific data relating to whether phthalates pose a credible risk to specific vulnerable patient populations, instead referring readers to the Committee’s 2015 update to its report ‘The safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk’.
The European Commission and SCHEER are holding a joint public hearing in Brussels on the Preliminary Guidelines on 4 April 2019. Interested parties will be invited to submit comments on the scientific evidence online before 29 April 2019, via an electronic template.