Regulation (EU) 2024/1860: ce que cela signifie pour Healthcare & Medical Devices

Ce que fait l'acte

to address risks of shortages of in vitro diagnostic medical devices in the Union and ensure the timely roll-out of Eudamed. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)) of the European Parliament and of the Council set a strengthened regulatory framework for medical...

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Pourquoi cela compte pour Healthcare & Medical Devices

Healthcare, medtech and digital-health companies face EU rules on medical devices, diagnostics and health data. These are the EU acts most likely to apply.

Lex publie la connexion source entre le texte officiel et le secteur; l'impact précis dépend de l'entreprise, de ses produits et de ses marchés.

Autres textes dans le corpus Healthcare & Medical Devices

• Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices32022R0123
• Council Directive (EU) 2020/2020 of 7 December 202032020L2020