In order to ensure a high level of protection of public health and patient safety, while safeguarding the smooth functioning of the internal market, as well as to provide legal certainty and avoid potential market disruption, it is necessary to extend further the transitional periods laid down in Regulation (EU) 2017/746 for devices covered by certificates issued by notified bodies in accordance with Directive 98/79/EC and for devices which are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746. To achieve those objectives, the extended transitional period should concern all device classes so as to guarantee a manageable distribution of workload across notified bodies in time, and to avoid any impediment to the certification process.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
