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Monday, May 6th

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Do you market class I medical devices under the Directive, which have been reclassified to a higher class under MDR?

According to Regulation (EU) 2023/607, you have to submit an application for certification to a notified body before the May 26, 2024, deadline, in order to benefit from the transition period for this category of devices.

Without this application, you will no longer be able to benefit from this status under the directive, and your devices will only be able to be marketed again once CE marking has been obtained under MDR.

GMED is mobilizing its teams to support you within the deadline.

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Do you market class I medical devices under the Directive, which have been reclassified to a higher class under MDR?

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