Logo Certiquality

CERTIQUALITY, as N° 0546 Notified Body in keeping with 93/42 EC Directive, performs the auditing services according to the different forms of the Directive, and issues the relevant statement of approval for affixing the CE marking.

 

According to the Directive the manufacturer must draw up the prescribed technical leaflet, specifying the class which the relevant device belongs to, its destination and, when applicable, the additional mandatory or voluntary obligations it must comply with.

 

The Medical Equipment classification according to the requirements of the Directive is essential to define the applicable conformity assessment procedure.

 

The Medical Equipment destination and classification are the manufacturer’s legal liability, therefore it is its duty to develop the in-house expertise, so as to be able to properly define the class which the equipment belongs to. For all and any devices the Directive requires the manufacturer to meet the basic obligations and to draw up the statement of conformity.