In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices.
D'fhonn aicmiú rioscabhunaithe oiriúnach a fháil ar fheistí atá comhdhéanta de shubstaintí nó de theaglamaí de shubstaintí a ionsúitear i gcorp an duine nó a scaiptear go logánta i gcorp an duine, is gá rialacha sonracha aicmithe a thabhairt isteach d'fheistí den sórt sin.