Immediately effective prolongation of timelines for implementation of Regulation (EU)2017/746
The pandemic has a tight grip on the world. The healthcare authorities and institutions further suffer from the additional workload. The planned implementation of Regulation (EU) 2017/746 regarding in vitro diagnostic medical devices (IVDR) comes to the worst possible point of time.
With the latest publication of the European Official Journal L 19/6 at January 28th, 2022 of Regulation (EU)2022/112 dated 25.01.2022, the EU intends to avoid the risk of artificially triggered increase of pressure to the healthcare institutions or increasing shortage of healthcare products, which are badly needed for other purposes during the pandemic.
This regulation, which comes immediately into force letting out some usual agreement steps due to the pandemic, newly defines the timelines given in IVDR Art. 110 and adopts Art. 112 and 113 accordingly. The prolongation of timelines concerns all risk classes of the IVDR.
We prepared a synoptic chart for you for an easier overview of the new timelines:
If you have any questions, TentaConsult Pharma & Med GmbH will be happy to advise you!
Your contact:
Frauke Stamm
Senior Consultant
+49 251 928715-67
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Source: https://www.tentamus-web.com/tentaconsult-en/2022/02/02/new-timelines-for-ivd-in-europe/