As regards the periods needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with Regulation (EU) 2017/746 of in vitro diagnostic medical devices that are covered by a certificate or a declaration of conformity that was issued in accordance with Directive 98/79/EC, a balance should be struck between the limited available capacity of notified bodies and ensuring a high level of patient safety and public health protection. Therefore, the length of the transitional period should depend on the risk class of the in vitro diagnostic medical devices concerned, so that the period is shorter for such devices belonging to a higher risk class and longer for devices belonging to a lower risk class.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
