To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted.
Chun sábháilteacht othar a fheabhsú agus chun aird chuí a thabhairt ar dhul chun cinn teicneolaíochta, ba cheart an córas aicmithe atá ann faoi láthair d'fheistí a leagtar amach i dTreoir 98/79/CE a athrú ó bhonn, i gcomhréir le cleachtas idirnáisiúnta, agus ba cheart nósanna imeachta um measúnú comhréireachta an chórais sin a leasú dá réir.