EU/US MRA (mutual recognition agreement): impatience over inactivity:
This article was originally published in Clinica
Executive Summary
With no significant developments on the mutual recognition agreement (MRA) on medical devices between the EU and the US in recent weeks, impatience is rising. Both sides have accepted the observed audits in readiness to appoint the conformity assessment bodies (CABs) and no audits are pending. It seems that it is now up to higher levels of administration in Europe and the US to ensure that the legalities are processed correctly before the next steps can be taken to formally list the CABs and fully implement the MRA. One bureaucratic step that must be achieved before progress is made is approval of the MRA by the EU's Article 133 Committee, which must give the go-ahead of the full implementation phase. This Committee is a meeting of member state representatives who co-ordinate trade policy among EU members and have the opportunity to comment on the conclusion of trade agreements. Its approval then has to be followed by a meeting of the EU/US MRA joint committee to agree to the formal listing of both sets of CABs.