IVDD Legacy Device Transition Period Ends: Class A Sterile and Class B

IVDD legacy devices that were up-classed to Class A sterile and Class B under the IVDR, are no longer recognized. To continue placing these devices on the market, they must be CE Marked to the IVDR.

This is outlined in the IVDR 110(3b(c)), which establishes the timeframe through 31 December 2029, as long as the conditions outlined under Article  110(3c) are met:

“Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates: (a) 31 December 2027, for class D devices; (b) 31 December 2028, for class C devices; (c) 31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.“

Any international authorizations leveraged via the IVDD legacy device status likely also expire today, e.g., Australia, UK, Switzerland.