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Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available

mdi Europa GmbH

发布日期: 2024年8月8日

Regulation (EU) 2024/1860 (amending Regulation to the IVDR) provides for an extended transition period of IVD medical devices. It has been published in the Official Journal of the EU (OJEU) and thus entered into force in July 2024.

To make use of the extended transition period, manufacturers should issue a self-declaration and be able to present a confirmation letter issued by the notified body that will conduct the IVDR conformity assessment. The European Commission has now published two drafts for this purpose, one was developed by MedTech Europe, the other by NBCG-Med.

You may access the documents under this link: Click

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