MDCG 2024-16: New Form for Reporting Device Supply Issues

MDCG 2024-16 was published on Friday 6th December which is a form linked to the Q&A document released in October 2024, “The information in obligation in case of interruption or discontinuation of supply of certain medical devices and in-vitro diagnostic medical devices.” The new form is the method for the manufacturer, its mandated Authorized Representative or any other actor acting on behalf of the manufacturer to inform the competent authority of the member state (that the manufacturer or authorized representative is established) about the interruption or discontinuation of the device in the market (Q11 of Q&A document).

MDCG 2024-16: Manufacturer Responsibilities Explained

The instructions to fill the form are included in the Q&A document and also outline the responsibilities of the economic operators involved in supplying the device to be in compliance with Article 10a of Regulation (EU) 2024/1860 amending the MDR and IVDR. The provisions of Article 10(a) will apply from 10 January 2025.

Impact for Manufacturers:

The form will need to be used for all classes of medical devices that are supplied to the market. It is required for an anticipated interruption/discontinuation as well as unexpected events. Progress updates also need to be submitted to the competent authority of the countries impacted.

Impact for MedEnvoy:

MedEnvoy can be mandated to submit this information on behalf of the manufacturer. MedEnvoy will also be obliged to inform the other economic operators in the downstream supply until it reaches the relevant health institutions or health care professionals.

New Form MDGC 2024-16: md_mdc-2024-16_en.pdf

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Compliance with MDCG 2024-16 and Article 10a is critical for manufacturers, Authorized Representatives, and other economic operators to ensure uninterrupted market access and regulatory alignment. For additional guidance contact us for expert assistance.

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• • • EU Authorized Representative
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