New quality standards for bodies certifying medical devices and in vitro diagnostic products in the EU
05 May 2026
Effective: 04 May 2026
94 views
Who is affected:
Notified bodies, manufacturers of medical devices and in vitro diagnostic products
Summary
The EU establishes uniform quality management requirements for notified bodies that certify medical devices and in vitro diagnostic products. It affects how these bodies must operate and document their evaluation processes.
Detailed analysis
PRO
Implementation Regulation 2026/977 harmonizes quality management and procedural requirements applicable to notified bodies performing conformity assessments under MDR (2017/745) and IVDR (2017/746) Regulations. It establishes uniform standards to ensure consistency and rigor in medical device certification processes th…
Full official title
CELEX:32026R0977: Reglamento de Ejecución (UE) 2026/977 de la Comisión, de 4 de mayo de 2026, por el que se establecen determinados requisitos uniformes de gestión de la calidad y de procedimiento para las actividades de evaluación de la conformidad realizadas por un organismo notificado designado con arreglo a los Reglamentos (UE) 2017/745 y (UE) 2017/746 del Parlamento Europeo y del Consejo