Council Directive 90/385/EEC [3] and Council Directive 93/42/EEC [4] constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices.
Is iad Treoir 90/385/CEE ón gComhairle [3] agus Treoir 93/42/CEE ón gComhairle [4] creat rialála an Aontais maidir le feistí leighis, seachas feistí leighis diagnóiseacha in vitro.