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EU MDCG Latest Update - July 2026
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Click on the title of the "documents" to be redirected to the original website. In the "Summary" column, we've included key information to help you determine whether the topic is relevant to your products. Enjoy reading!
| Documents | Summary |
|---|---|
| MDCG 2026-5 – UDI Assignment Between Manufacturers and Distributors |
The document clarifies that the assignment of the UDI-DI is the responsibility of the manufacturer, not the distributor. The position paper addresses the need to prevent improper practices in which distributors request UDI-DIs in their own name for devices manufactured by others. MDCG confirms that the manufacturer remains responsible for assigning, maintaining, and registering UDIs in EUDAMED. A third party may provide operational support to the manufacturer, but ultimate responsibility rests with the manufacturer. Practical Impact: It is necessary to review and, if necessary, update EUDAMED procedures, internal responsibilities, etc. |
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