Update MDCG 2023-3 / Q&A about new article 10a (EU MDR and IVDR) / Webinar: AI for RA Professionals

Dear Reader

Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe.

Regulation and Guidelines:

1.) Updated: MDCG 2023-3 Rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG has changed and updated several questions. Here are the main changes:

Expanded scope: The document now covers both the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Restructuring: Questions have been renumbered, and a table of contents has been added for better navigation.
New content: Several new questions and examples have been added, particularly related to IVDs.
Clarifications: Existing definitions and explanations have been refined, with more specific examples provided.
Regulatory alignment: The document has been updated to align with the latest regulatory requirements, including references to new standards and guidelines.

2.) Q&A - on practical aspects related to the implementation of Article 10a

The Q&A on practical aspects related to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a MDR and IVDR as introduced by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. These are the key points:

Effective Date: New obligations under Article 10a begin on January 10, 2025, requiring manufacturers to report any anticipated supply interruptions or discontinuations with potential serious health impacts.
Wide Applicability: This applies to all devices on the EU market (except custom-made devices), regardless of the manufacturer’s location.
Notification Protocol: Manufacturers must notify relevant operators, health institutions, and authorities six months in advance unless exceptional cases arise.
Risk Assessment: Manufacturers must evaluate if a supply disruption could cause serious harm, factoring in the device's use, patient demographics, and alternative options.
Cascading Communication: Information flows down the supply chain to ensure timely awareness, with each link responsible for prompt and accurate sharing.

Link to document

What else could be interesting:

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Thank you and have a great day!

Your Regulatory Globe Team