Impact of (EU) 2024/1860 on legacy devices and update on BSI implementation >
On 9 July 2024, the Regulation (EU) 2024/1860 has been published in the Official Journal of the European Union (OJEU) with immediate effect. The objective of the amending Regulation is to address the projected imminent risks of shortages of in vitro diagnostic medical devices in EU due to the slower than anticipated transition from the In Vitro Diagnostic Directive (IVDD) to the IVDR.
