Regulation 7 Classification of general medical devicesE1

For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 F1, read with Directive 2003/12 F2and Directive 2005/50.

In the event of a dispute between a manufacturer and F3an approved body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50.