Not suprisingly, the costs associated with CE marking vary greatly, largely determined by the level of risk posed by the device.
The Directive is quite involved and meeting the requirements can be very time consuming. The majority of devices will need to satisfy the requirements of the Medical Devices Directive 93/42/EEC, but the exact requirements will depend on the class of product, either I,IIa,IIb, or III.
Depending on the class, a “Notified Body (NB)” will need to be commissioned to ensure the device conforms and that the documention and quality systems of the manufacturer are in order.
This, in conjunction with the expense of ensuring the device meets all aspect of the Directive are where the costs mount up.