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Notified body to leave Denmark in 2020

Norwegian Presafe has caught the Danish Medicines Agency and Medicoindustrien, the Danish industry association for medtech companies, unawares by deciding to close its notified body in Denmark. Medicoindustrien calls the decision “problematic” while the Danish Medicines Agency is now looking for opportunities to establish a new agency in the country.

From 2020, Denmark will stand without a notified body.

Norwegian Presafe has decided to consolidate its business and will not apply for a new EU authorization for its Danish branch office to enforce the new directives for medical (MDR) and in vitro-diagnostic devices (IVDR).

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