European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
Some Products To Get Until 2025-2027 For Compliance
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.
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While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.
With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, the EU could lose between three-quarters and over a half of its IVDs, a recent survey warns.