What is the EU/US medical device MRA?
This article was originally published in Clinica
Executive Summary
The mutual recognition agreement (MRA) is a bilateral agreement between the US and the EU, which establishes procedures to simplify product and system approvals by the FDA and its European counterparts. It recognises that certain conformity assessment bodies (CABs) in the EU are capable of conducting product and quality system evaluations according to US regulatory requirements equivalent to those conducted by the FDA, and vice versa.