Lodge Application with Notified Body: Class C IVDs

Manufacturers with IVDD legacy devices up-classed to Class C under the IVDR, must have lodged an application with a Notified Body by today.

This is outlined in the IVDR Article 110(3c)(e):

“the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, no later than: (i) 26 May 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article; (ii) 26 May 2026, for devices referred to in paragraph 3b, point (b), of this Article; (iii) 26 May 2027, for devices referred to in paragraph 3b, point (c), of this Article;“

Otherwise, the device ceases to be a legacy device.