Where we stand with MDR and IVDR
European regulations about Medical Devices (Reg. EU 2017/745) and In-vitro Diagnostics (Reg. EU 2017/746), since their publication in 2017, have undergone several extensions. Initially due to COVID-19 pandemic and then because of the lack of an adequate number of Notified Bodies, which are appointed to the evaluation and approval for MD and IVD technical files. Those delays have potential impacts on Medical Devices and In-vitro Diagnostics availability for end-users.
With last extensions approved by European Commission, it is expected that new Medical Devices and In-vitro Diagnostics produced and made available on the market will be compliant no longer with the Directive, but only with the Regulation no later than 2029.
What is new about DEHP
In order to line up with new extensions, on November 13th, 2023, the European Commission published Regulation (EU) 2023/2482, which modified the Annex XIV of Regulation (EC) 1907/2006 (REACH).
This regulation extends the latest application date for authorization to use Bis(2-ethylhexyl) phthalate (DEHP) in Medical Devices and In-vitro Diagnostics.
DEHP is a phthalate used ad plasticizer and is listed in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) as a Repr. 1B (H360FD) substance and is known to be an Endocrine Disruptor.
Previously, latest date for application and sunset date for authorization were November 27th, 2023, and May 25th, 2023, respectively.
With the new regulation, these deadlines will be extended until January 1st, 2029, for latest application date and July 1st, 2030, for sunset date for application.
This means that producers which want to have DEHP inside products have time until January 1st, 2029, to forward their request for authorization to use DEHP and have to receive a positive response by July 1st, 2030, otherwise their will not be allowed anymore to use it in their Medical Devices or In-vitro Diagnostics.
These new deadlines will allow stakeholders to manage properly registration of their devices and guarantee a full compliance with a better safety for the end-consumers.
For more information about the compliance of your Medical Device or In-vitro Diagnostic with all European regulations, contact our expert at chemsafe@chemsafe-consulting.com
Sources:
https://echa.europa.eu/en/authorisation-list/-/dislist/details/0b0236e1807e0026
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482
