Despite the increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/746, the overall capacity of notified bodies is still not sufficient to ensure the certification of the large number of in vitro diagnostic medical devices which are to undergo conformity assessment involving a notified body under that Regulation.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
