The route to CE-Marking
In order for a medical device to be marketed in the European Union it must have a CE mark. The CE mark is an indication that a product complies with the
of applicable directives and that it has been proven in a conformity assessment procedure. The placing of medical devices on the market is controlled primarily by three directives.
The CE-Marking is often seen as a \”boarding card\” for the European market. A product is allowed to be placed on the market and be used only when it complies with the according directives and when a conformity assessment procedure as specified in the applicable directive has been completed. But a CE-Marking is not only a must on the European Market, but is also an advantage on other international markets. CE is becoming the world\’s most common regulatory and safety mark.
The main stages to obtaining CE-Marking are:
- Definition medical device and intended use
- Classification of medical devices
- Identification of the appropriate conformity assessment procedure
- Technical file and Quality Management System
Regarding the classification of medical devices, the manufacturer can choose between various certification processes (conformity assessment procedures). The Class I non-sterile devices without measuring function do not require the involvement of a Notified Body. The whole responsibility for these devices and their CE-Marking lies with the manufacturer. All other devices (except special designs and products for clinical trials) require certification by a Notified Body, for example MEDCERT. Only after a successfully completed certification procedure can the manufacturer place the CE-Marking with the according four digit number for the Notified Body on the product (e.g. 0482 for MEDCERT) and sell its devices on the European market (please see also European Representative).
Generally speaking, for devices in Classes IIa, IIb and III, the manufacturer may choose between 3 to 4 different routes to obtain a CE-Marking which can sometimes be confusing. Therefore, it is recommended to involve the Notified Body in this decision process as soon as possible.