Europe rejects FDA audits under MRA (mutual recognition agreement)
This article was originally published in Clinica
Executive Summary
Europe is taking a stronger position regarding the terms of the mutual recognition agreement (MRA) with the US in medical devices. A recent meeting of European experts decided that audits undertaken so far by the FDA in Europe in the presence of EU conformity assessment bodies (CABs) do not count as part of the MRA confidence-building programme. The reason is that the FDA did not give companies sufficient notice of the audits.