The phthalate DEHP is on the REACH Authorisation List and must be phased out of medical devices and replaced with suitable alternatives. If this results in significant changes to the medical device, the product must be re-certified by a notified body.
As notified bodies will not be able to approve devices with DEHP-free alternatives within the transitional period, the application date for DEHP replacement has been extended to 1 January 2029 in a new amendment to the Commission Regulation on medical devices. This date applies to use in medical devices covered by Regulations (EU) 2017/745 and (EU) 2017/746.
After 1 July 2030, it will no longer be allowed to place medical devices with DEHP on the market. Consequently, manufacturers who cannot replace DEHP with an alternative will have to apply to the European Chemicals Agency, ECHA, for an authorisation to use DEHP in compliance with the conditions for substances of very high concern (SVHC) on the Authorisation List.
To find out more about SVHC substances in medical devices, please contact:
Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478
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