What is the EU CE Mark? An overview for medical device companies on CE in Europe

If you’re a medical device manufacturer interested in the European market, registration of your product will require obtaining a CE Mark in Europe, officially known as the CE marking.

What is the EU CE Mark?

The CE Mark in Europe is a legally required symbol for all products on the market in the European Economic Area that fall under New Approach Directives. For medical devices, the pertinent laws are the Medical Devices Directive (MDD 93/42/EEC), Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and In-Vitro Diagnostics Directive (IVDD 98/79/EC).

The purpose of the EU CE Mark is to notify European member state regulators that your medical device or IVD has been assessed by proper authorities, and complies with all applicable laws. This enables marketing, distribution and sales across Europe. The EU CE Mark does NOT indicate that a device was made in Europe, nor does it serve as a quality or customer assurance mark.

As the medical device manufacturer, you bear sole responsibility for ensuring compliance with New Approach Directives and obtaining an EU CE Mark for your medical device—even if you’ve outsourced some or all of your manufacturing.

How to Obtain the CE Mark in Europe

The EU CE Mark is required for all medical devices, regardless of classification. The process to obtain a CE Mark entails device classification and technical file preparation, quality system implementation and authorized representative selection, among other steps. (See a step-by-step explanation of the European CE Marking process.)

Benefits of the CE Mark in Europe

Obtaining an EU CE Mark for your device allows you to market, sell and distribute your product throughout the EU’s 27 member states, which have a combined population of more than 500 million people. CE marking also allows access to Switzerland, Norway, Liechtenstein and Iceland, which are not EU members but do recognize the CE Mark. In addition, some other medical device markets such as Australia and Turkey allow expedited reviews of devices that have earned the CE Mark, enabling you to tap into those markets faster and with less expense.