The European Commission has recently revised Regulation (EC) No 1907/2006, extending the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Originally, the use of DEHP was to be subject to authorisation requirements after May 2025, but the new regulation, EC 2023/2482, issued on November 13, 2023, postpones this deadline. This amendment aligns with the extended transitional periods for medical device regulations (EU) 2017/745 and (EU) 2017/746, reflecting the need for a gradual shift to DEHP-free medical devices.
Key points of the amended REACH authorisation requirements
- Extension of the sunset date for DEHP use in medical devices to July 1, 2030.
- Latest application date for uses of DEHP in medical devices is set to January 1, 2029.
- Assurance of continued availability of medical devices during the transition to DEHP-free alternatives.
- Acknowledgment of the challenges faced by companies in replacing DEHP amidst regulatory complexities.
This regulatory change aims to maintain public health and patient safety standards while addressing the limited capacity of notified bodies and the challenges companies face in transitioning to DEHP-free alternatives. The Commission emphasises the importance of ensuring a high level of protection for health services and patients, without compromising current quality and safety requirements.
Successful advocacy by the medical device industry
The changes are the result of a positive engagement between industry and regulators on the impact of regulation on market sectors. Working together enables better regulation to protect human health and the environment.
For years, DEHP has been one of the most commonly used plasticisers in medical devices including the following applications:
- Blood bags & intravenous bags
- Nutrition pockets
- Tubing
- Catheters
- Respiratory masks
- Disposable gloves
Earlier this year, MedTech Europe welcomed the positive opinion of the REACH Committee of extending the latest application date and the sunset date to the new transition period of the sector-specific Medical Devices Regulation.
What next?
Use of DEHP in medical devices within the European Economic Area (EEA) will necessitate authorisation post the extended sunset date. This delay offers manufacturers using DEHP an opportunity to innovate and integrate DEHP-free alternatives into their devices. Should the new deadlines not provide sufficient leeway, EEA-based manufacturers are advised to seek authorisation before the newly set application date.
Keep updated with Signal for the latest developments and expert analysis on this and other pressing medical device matters as they unfold.
