The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.
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 SCHEER adopted the Guidelines on 18 June 2019 after a public consultation. The Guidelines build upon the Scientific Committee’s on Emerging and Newly-Identified Health Risks (SCENIHR) Opinion on the safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update).
The Guidelines explain that phthalates are widely used in industry as plasticisers of polymers and as additives. The phthalates may be released into the environment and into the human body if the medical device is in contact with it. The Guidelines provide guidance on when and how to determine whether the use of phthalates can be justified.
Chapter II Section 10.4 of Annex I to the MDR allows for a limited use of CMR 1A/1B and/or ED substances in medical devices when a Benefit-Risk Assessment justifies the use of the phthalates.
The Guidelines provide a step by step overview on how to assess the use of the phthalates by conducting a benefit-risk assessment. The steps that need to be considered include the availability of alternative substances, materials, designs and medical treatments and the risk of the use of the phthalates compared to the available alternatives. Manufacturers need to evaluate the impact of the possible alternatives on the functionality, performance and the overall benefit-risk ratio of the medical device.
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 provide that the above-mentioned approach may also be used to conduct a benefit-risk assessment of other CMR/ED substances present in medical devices.
The Guidelines have been prepared in light of the EU MDR. It can, however, not be excluded that competent authorities and notified bodies will consider these Guidelines as the state of the art guidance concerning the use of phthalates in medical devices.
Please do not hesitate to contact us if you have questions about these new guidelines.
Authored by Fabien Roy and Alexander Wenzel
 CMRs are classified in accordance with Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures in the EU.