The number of applications for conformity assessment of in vitro diagnostic medical devices submitted by manufacturers and the number of certificates issued by notified bodies to date indicate that the transition towards the regulatory framework established by Regulation (EU) 2017/746 has not progressed in a way that would ensure a smooth transition to the new rules under that framework.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
