(1) All medical device shall be:

• appropriately classified in accordance with the classification rules as specified in FIRST SCHEDULE; and
• appropriately grouped using the rules of grouping as specified in SECOND SCHEDULE.

(2) In the event of any dispute between the establishment and a conformity assessment body over a classification of a medical device, the establishment may request in writing to the Authority within thirty (30) days from date of dispute to decide on the matter.

Source: Medical Device Regulation 2012