Submit IVDR Applications for Class D Devices Before the End of 2023
Team-NB, the European association of Notified Bodies, strongly recommends that medical device manufacturers of Class D devices submit applications for In Vitro Diagnostic Regulation (IVDR) certification this year to ensure timely processing.
The EU has extended the transition period for the IVDR, but Team-NB fears difficulties due to the long testing times for high-risk devices (13 to 18 months).
The focus on Class D IVDs reflects the staggered timetable for IVDR compliance. Manufacturers of Class D devices that test for life-threatening conditions must comply with the IVDR by 26 May 2025. To date, 231 applications have been received by Notified Bodies.
Team NB members are committed to speeding up the process, but warn of supply chain and access issues for IVDs in the EU if applications are delayed.
Source:
Team-NB: Latest News
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