CE marking has been around for over 25 years, yet misunderstandings still exist as to what the CE mark means, how to get a CE mark, and how much it costs.
With the aim of protecting consumers and making sales to member European Union (EU) states easier, the CE mark indicates that a manufacturer is satisfied that their device conforms to the relevant regulations.
Mandatory for all products being sold in the EU (from any country), with regards to medical devices the CE mark indicates that the product is fit for its intended purpose and meets the essential requirements the relevant Medical Devices Directive.
The complexity of the device and the potential risk to consumers determines the route to CE marking and the costs of CE marking.