EC: SCHEER Opens Call for Information for Guidelines Updates on Phthalates in Medical Devices

ARQon
May 24, 2023
2 min read

Updated: May 30, 2023

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) received requests from the European Commission to review and update the guidelines for the benefit-risk assessment of phthalates in certain medical devices. The benefit-risk assessment has to take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs, or medical treatments.

The requests have been made to be aligned with the legal command under the EU Medical Device Registration (EU MDR) 2017/745, in Section 10.4.3 of Annex I MDR - General Safety and Performance Requirement (GSPR). The targeted medical devices with the presence of phthalates that are carcinogenic, mutagenic, toxic to reproduction (CMR) and endocrine-disrupting (ED) properties. The EU MDR 2017/745 also commands to update the guidance, at least 5 years with the latest scientific studies.

Phthalates help the components of medical devices to be more durable, increase flexibility and soften the materials such as tubes in the devices. Hence, Phthalates are used in many medical devices including electronic medical devices.

The guidelines update is advised to focus on the medical devices that:

Invasive and require direct contact with the human body
Use to administer the medication, body liquids, substances to/from body
Use as storage or transportation medium for medicines, body fluids or substances to pass through the body

Hence, the call for information is collecting data and information on:

The application experiences and the frequency of use of current guidelines
Information on phthalates used as plasticizers in medical devices
Evaluation of the probability of the patient’s exposure to the substance
Examine the possible alternative in terms of substances, materials, designs or medical treatments
Prepare a complete justification of why the possible substances are deemed not suitable to maintain the functionality and performance for medical treatments including the risky group of patients (breastfeeding women, pregnant women, children).

SCHEER opens the call for information to the public and the submission deadline will be on 17 July 2023. The guidelines must be implemented by 18 June 2024.

Source: European Commission