(EC) 2023/2482 amending Regulation (EC) No 1907/2006
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🇪🇺(EC) 2023/2482 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices
Annex XIV of Regulation (EC) No 1907/2006 is amended in accordance with the Annex of this Regulation:
Latest application date concerning the substance bis(2-ethylhexyl) phthalate (DEHP) is replaced by the following:
1st January 2029 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746;
Sunset date concerning the substance bis(2-ethylhexyl) phthalate (DEHP) is replaced by the following:
1st July 2030 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.
Delays caused by the limited capacity of notified bodies should not penalise companies in the process of substituting DEHP in medical devices. The alignment of the latest application date and sunset date in Regulation (EC) No 1907/2006 for uses of DEHP in medical devices is needed to allow companies first to meet the requirements of the regulatory framework for medical devices, prior to deciding on the need for an application for authorisation, as that would only be needed in case the DEHP-free alternative medical device is not ready.
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Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).
CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR transition in its entirety
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