CE Marking

Products labeled with the CE symbol conform to the European Union (EU) directives as mandated by EU member state legislation and are available for sale in Europe to countries that accept CE marking with restrictions as may be noted. Medical devices labeled with this marking means the product is in conformity with the European Medical Directive (MDD): 93/42/EEC Council Directive of 14 June 1993 on the approximation of the laws of the Member States concerning medical devices.

The CE symbol provided with some products in the Philips Medical Supplies Reference Guide and in the online Store is intended only as an indication of availability in EU countries and is not intended as a legal product marking.

CE indicated products may not be available in all EU countries due to local requirements.

Countries Accepting CE-Marked Products

In order for a product to be able to be labeled with the CE marking, product quality and manufacturing quality systems must be documented to comply with certain standards.  Compliance with the European directives and regulations ensures a standard level of performance for device function, safety, and health protection for users, patients, and others.

Non-medical products that comply with other harmonized directives may also bear the CE mark.

Countries that accept CE marked products include Austria, Belgium, China, Cyprus, Czech Republich, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.  A CE mark does not necessarily indicate that a product is marketed or distributed in all of the countries listed above.

Non-medical products that comply with other harmonized directives may also bear the CE mark.

Each Philips medical product that is labeled with the CE marking is identified with either CE, CE0366, or CE0123.  Other manufacturers' CE marking symbols may include but not limited to CE0336.