Danish notified body expected approved in 2023

More than a year will pass before Denmark will once again have a notified body for the approval of medtech products. Industry association Medicoindustrien warns of a ”huge capacity crisis,” which will only grow – particularly affecting one part of the industry.

German Tüv Süd continues to be the only applicant to become a notified body in Denmark

BRUSSELS – Although the medtech industry warns of a greater ”capacity crisis,” the sector shouldn’t be expecting to have products approved locally in Denmark for sale in the EU any time soon.

This message comes from one of the central players in the extensive approval process, the Danish Medicines Agency. The authority tells MedWatch that the case processing of an application from German Tüv Süd to become a notified body in Denmark isn’t anticipated to be concluded before summer 2023.

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