For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments.
Ar chúiseanna staire, rinneadh rialáil ar fheistí leighis so-ionchlannaithe gníomhacha, a chumhdaítear le Treoir 90/385/CEE, agus ar fheistí leighis eile, a chumhdaítear le Treoir 93/42/CEE in dhá ionstraim dhlíthiúla ar leith.