Article 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), asamended by Regulation (EU) 2022/1121, states that under certain conditions the following devices may be placed on the market or put into service after the date of application of the IVDR, i.e. 26 May 2022, until the end of the different transition periods specified in Article 110(3) IVDR:
– devices which have a valid certificate issued by a notified body under the Directive
98/79/EC on in vitro diagnostic medical devices (IVDD), and
– devices for which a declaration of conformity was drawn up prior to 26 May 2022 in
accordance with the IVDD and for which the conformity assessment procedure
pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified
body.
In line with Q&A 9 of the CAMD’s FAQ – IVDR Transitional provisions, the certificates
covered by Article 110(3) of the IVDR include all certificates which are commonly issued by
notified bodies3 with reference to the IVDD…
