To ensure a progressive transition to Regulation (EU) 2017/746, the appropriate surveillance regarding in vitro diagnostic medical devices benefiting from the transitional period should be transferred from the notified body that issued the certificate in accordance with Directive 98/79/EC to a notified body designated under Regulation (EU) 2017/746. For reasons of legal certainty, the notified body designated under Regulation (EU) 2017/746 should not be responsible for conformity assessment and surveillance activities carried out by the notified body that issued the certificate.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
