Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months.
Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED
Regulation 2024/1860 was officially released to extend the transition time for legacy IVDs, roll out EUDAMED, and require data on disruption in supply as Article 10a Medical Devices Regulation (2017/745, MDR) and the In Vitro Diagnostics Devices Regulation (2017/746, IVDR). This was long awaited and formalized aspects that were discussed for over six months. Discussions related to Article 10a are still ongoing.
In the table below, we present the impending deadlines for legacy IVDs. One legacy element is that the IVD was placed on the market before the IVDR Date of Application (DoA), May 26, 2022.
The legacy IVD could continue to be placed on the market up until the date in the last column of the table, provided other conditions were fulfilled. This is based on the classification of the IVD to the IVDR, and the condition (Notified Body In Vitro Diagnostics Devices Directive 98/79/EC (IVDD) CE marking certificate or self-certified IVDD and up classified under the IVDR). Among the requirements is an IVDR application to a Notified Body and a signed agreement with the Notified Body for the legacy IVD or a substitute IVD by the dates specified in the table.
EU Update: Current State of Medical Device Regulations | Emergo by UL
EU Update: Current State of Medical Device Regulations
Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months.
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