Sign Agreement with Notified Body: Class C IVDs

Manufacturers with IVDD legacy devices up-classed to Class C under the IVDR, must have a signed written agreement with a Notified Body by today.

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

“the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII no later than: (i) 26 September 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article; (ii) 26 September 2026, for devices referred to in paragraph 3b, point (b), of this Article; (iii) 26 September 2027, for devices referred to in paragraph 3b, point (c), of this Article.“

Otherwise, the device ceases to be a legacy device.