FW: Medical devices

The device will need CE, thus the typical route is a tech file and a DoC. Refer to the Medical Device Directive (MDD) or the In-Vitro directive. From the little info you provided I would guess the Medical Directive is the one. Reading the scope of both should assist you in selecting the

FW: Medical devices

Kim, Check out http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist.html From that page you can get to both the In Vitro Diagnostic Medical Devices Directive and the Medical Devices Directive, as well as the Harmonised Standards for these Directives. It sounds