It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice.
Is gá, chun críche na nósanna imeachta um measúnú comhréireachta go háirithe, feistí a aicmiú i gceithre aicme riosca agus sraith de rialacha láidre riosca-bhunaithe a bhunú maidir le haicmiú, i gcomhréir leis an gcleachtas idirnáisiúnta.