Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

Article 110(2) and 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) state that devices which are covered by valid certificates issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) may be placed on the market1 or put into service2 after the date of application of the IVDR and no later than 26 May 2025 under certain conditions.

The abovementioned conditions require that the notified body that issued the certificate
under the IVDD continues carrying out appropriate surveillance in respect of the applicable
requirements relating to the devices it has certified. Therefore, it is important for
manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 110(3) of the IVDR…