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US moves closer to agreeing MRA (mutual recognition agreement) start date with EU

This article was originally published in Clinica

Executive Summary

There is still no news of the official start date of the implementation period for the US/EC medical device Mutual Recognition Agreement, but it is surely approaching fast. There are two testing and certification organisations in the US now ready to be listed as conformity assessment bodies (CABs) with a third due to be audited this month. The FDA has also just notified the European Commission of a new observed audit that needs to take place in Texas in April.

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