The IVD Directive places in vitro devices into different classification groups which determine how manufacturers go about demonstrating compliance. For devices that are perceived to be higher risk, a Notified Body will need to be involved in the conformity assessemnt process, wheras for lower risk devices, 'self-declaration' is permitted.
For higher risk devices, the legislation provides a choice of assessment routes for manufacturers, who can select an appopriate combination of Annexes from the Direcive to provide a pathway to CE marking.
For example, for low risk devices, Annex III explains the applicable process, whereas for devices that appear in List A or List B of Annex II, or for devices intended for 'self-test' there must be Notified Body involvement in either the manufacturer's quality system or in batch release.
GEMAR can help you identify the classification and conformity assessment route options for any device, potentially avoiding unnecessary work and expenditure - contact us for further information.