Commission Regulation (EU) 2023/2482 of November 13, 2023, amending Regulation (EC) No 1907/2006 (REACH) of the European Parliament and of the Council as regards the substance bis (2-ethylhexyl) phthalate (DEHP) in medical devices (MDs), has been published in the Official Journal of the European Union.
The latter amends the transitional provisions set out in Annex XIV of the REACH regulation relating to the use of DEHP in MDs and in vitro diagnostic MDs, in line with those set out in Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).
Devices incorporating DEHP for which no application for the use of the said substance has been submitted to the European Chemicals Agency by January 1, 2029, may continue to be placed on the market until July 1, 2030.
Regulation (EU) 2023/2482 thus introduces this additional period, enabling the manufacturers concerned to concentrate their efforts on bringing their devices into conformity with MDR and IVDR requirements, without being forced to stop placing their legacy devices on the market.
share
Events
Find an answer to the challenges you are facing in one of our upcoming events: trainings, webinars, forums...