This Regulation is being adopted in view of the exceptional circumstances arising from an imminent risk of shortages of in vitro diagnostic medical devices and the associated risk of a public health crisis, as well as the significant delay in the development of the electronic system on clinical investigations and performance studies of Eudamed. In order to attain the intended effect of amending Regulations (EU) 2017/745 and (EU) 2017/746 and to ensure the availability of such devices the certificates of which have already expired or are due to expire before 26 May 2025, to provide legal certainty for economic operators and healthcare providers, and for reasons of consistency as regards the amendments to both Regulations, this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
