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 mitigation of risk of shortages 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 this topic are set out in a separate document.
2. Regulation (EU) 2024/1860 also imposes a requirement on manufacturers to inform their relevant competent authority and health institutions before the supply of certain medical devices or IVDs is interrupted or discontinued. If manufacturers do not supply directly to health institutions or healthcare professionals, they must inform the relevant economic operators in the supply chain, which then must inform the health institutions. This mechanism will enable the competent authority and health institutions to consider mitigating measures to ensure patient health and safety. Questions and answers regarding this topic will be set out in a separate document.
3. Regulation (EU) 2024/1860 also enables a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. Questions and answers regarding the gradual roll-out of Eudamed are set out in this document
Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 202
Gradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 (November 2024)
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