CE marking is the term given to medical device ‘approvals' in the European Economic Area, including Switzerland. The term ‘approvals' is in quotes since in the final analysis CE marking is a Declaration of Conformity by the manufacturer of the medical device - whatever the Class of medical device. For all except Class I products, this declaration can only be made on the basis of a certificate from a Notified Body. CE marking is structured in this way so that it is clear that the burden of product liability rests with the manufacturer, and not with the Notified Body.

Once obtained, CE marking allows the product to be sold in each of the states of the European Economic Area (the 27 EU Member States plus Iceland, Norway, Liechtenstein and Switzerland).

Priory Analysts specialises in taking companies of all sizes and products of all types through CE marking.