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Happy New Year! We wish you a healthy and successful 2025! Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe.

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Regulation and Guidelines:

Mandatory: Article 10a of the EU MDR: Supply Interruption or Discontinuation Notification

From today (January 10, 2025) Manufacturers must inform relevant parties about anticipated interruptions or discontinuations in device supply that could result in serious harm or risk of serious harm to patients or public health.

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Updated: MDCG 2023-3 Rev. 2

This document aims to clarify important terms and concepts outlined in Section 2 of Chapter VII of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It provides guidance on the implementation of vigilance requirements under these regulations, focusing on definitions, reporting criteria, and processes related to incidents and serious incidents for medical devices and in vitro diagnostic medical devices.

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Updated: MDCG 2024-7 Rev.1 - Preliminary assessment review template - MDR (Regulation (EU) 2017/745)

This document serves as a template for Designating Authorities (DAs) to review applications from Conformity Assessment Bodies (CABs) seeking designation as Notified Bodies under the Medical Device Regulation (EU) 2017/745. It covers various aspects of the CAB's organization, quality management, resources, and processes to ensure compliance with regulatory requirements.

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