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US industry holding up MRA (Mutual recognition agreement) with EU?

This article was originally published in Clinica

Executive Summary

The US needs to do more to encourage its industry to take part in audits under the proposed EU/US mutual recognition agreement (MRA) in medical devices, otherwise the MRA will never fully get off the ground. That is essentially the message of a letter that has been prepared by the European Commission, in co-operation with EU member states, as a counter-proposal aimed at clearing up some practical details surrounding the implementation of the agreement.

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