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DGM nomination increases pace of EU/US MRA (Mutual Recognition Agreement)

This article was originally published in Clinica

Executive Summary

The Danish notified body, DGM, has become the third EU testing and certification organisation to be named by the US FDA as competent to test independently to its medical device requirements under the Mutual Recognition Agreement (MRA) between the US and the EU. As a Conformity Assessment Body (CAB), it will be able to offer manufacturers based in the EU testing nearer to home, as well as offering current customers savings in terms of cost and time.

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