Introduction – Objectives of the MDR/IVDR amendment
The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics:
1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including the mitigation of risks related to discontinuation or interruption of supply of in vitro diagnostic medical devices (IVDs) needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given extra time to carry out, in accordance with the IVDR, the conformity assessment of IVDs covered by a certificate or a declaration of conformity issued in accordance with Directive 98/79/EC. Questions and answers regarding the extension of the IVDR transitional periods are set out in a separate document…
