It is very likely that many safe and critical in vitro diagnostic medical devices, which are essential for the medical diagnosis and treatment of patients, would not be certified in accordance with Regulation (EU) 2017/746 before the end of the transitional periods. This leads to a risk of shortages, especially of highest-risk (class D) devices, by the end of the current transitional period on 26 May 2025. It is therefore necessary to ensure that there is an uninterrupted market supply of in vitro diagnostic medical devices in the Union.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
