identify the class of the medical device
(see http://abr-ce.com/vendre-md-en-ce/medical-devices-3.html ) 

choose the way to fulfil the requirements to affix the CE mark
(see http://abr-ce.com/vendre-md-en-ce/ways-to-distribute-medical-devices-into-the-eec-market-2.html )

set up the technical file to meet the requirements of the Directive (check-list available)

set up the quality system in regards of the chosen way

be assessed by a Notified Body (except class 1 non sterile & non measuring)