Dear Reader

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

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Regulation and Guidelines:

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MDCG 2024-15: Clinical investigation reports and their summaries in the absence of EUDAMED

The document provides guidance on the procedure for publishing clinical investigation reports and their summaries until EUDAMED becomes fully functional. It outlines the submission process, labeling, management, and storage of these documents in a publicly accessible CIRCABC directory.

​Link to document​

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MDCG 2024-16: Manufacturer information form on interruption or discontinuation of supply of certain medical devices and certain in-vitro diagnostic devices

This document is a form to be completed by manufacturers or their authorized representatives to report on the interruption or discontinuation of the supply of certain medical devices and in vitro diagnostic medical devices. It is in accordance with Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

​Link to document​

​Link to Annex​

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Updated Q&A Obligation to inform in case of interruption or discontinuation of supply - article 10a EU MDR and IVDR (Rev.1)

This Q&A document is intended to facilitate the application of Regulation (EU) 2024/1860, which amends the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It focuses on the obligation of manufacturers to inform relevant parties about anticipated interruptions or discontinuations in the supply of certain medical devices and IVDs. The document provides clarity on the information-sharing obligations introduced in Article 10a of the MDR and IVDR.

​Link to document​

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MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

Revision update on MDCG 2019-13: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation.

​Link to document​

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MDCG 2022-3 Rev.1: Verification of manufactured class D by NB

This document provides guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the In Vitro Diagnostic Medical Devices Regulation (IVDR). It describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs.

​Link to document​

What else could be interesting:

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Regulatory Intelligence Service

We produce a monthly Regulatory Intelligence Paper for many different medical device manufacturers. It helps them stay up to date. We offer it in a general and cost-efficient way or also very company-specific according to the needs of the company. Get more information here.

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