Theme Transitional provisions
Target Audience Notified Bodies (NB)
Products concerned IVD
Regulatory reference IVDR (EU) 2017/746
Article 110
Documents mentioned MDCG 2022-4
MDCG 2022-6
MDCG 2022-8
MDCG 2019-10 rev.1
MDCG 2022-12
CAMD MDR/IVDR Transition subgroup : FAQ – IVDR Transitional provisions

Legacy devices with valid CE certificates issued in accordance with Directive 98/79/EC may continue to be placed on the market or put into service beyond the date of application of Regulation 2017/746 and until 27 May 2025 at the latest, in accordance with Article 110 (Transitional provisions) of the Regulation.

The last paragraph of Article 110 (3) of the Regulation states that “the notified body which issued the certificate […] shall continue to be responsible for appropriate surveillance in respect of all applicable requirements relating to the devices which it has certified.”

MDCG 2022-15 provides clarification on these legacy device specific surveillance activities to be conducted by Notified Bodies.