MRA (mutual recognition agreement) agreements provide opportunities and headaches for European notified bodies
This article was originally published in Clinica
European notified bodies are keen to become accredited by the US, Canada, Australia and New Zealand in the testing of medical devices. However, a serious lack of interest on the part of industry could mean that many notified bodies are on the point of making a serious business mistake - and one that exposes them to scrutiny by the US FDA.
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