What does the CE Mark on products mean?
CE marking has existed in its present form since 1993 and indicates the compliance with EU legislation of a product. A CE marked product can be manufactured anywhere in the world and allows its free movement for sale within the European market place.
When a product is CE marked a manufacturer is declaring its sole responsibility and conformity with all of the legal requirements.
Not all products sold in Europe are required to be CE marked; there are over 20 product categories that do require this standard and medical devices are one of these categories.
CE marking on medical devices must conform to the directive 93/42/EEC whereby annual external Audits are conducted by a Notified Body to approve compliance to the directive.
The labelling of Medical Devices is a key requirement of CE marking legislation and often symbols are used to identify certain details of information.
What symbols on Medical Devices actually mean:
Date of Manufacture
Lot / Batch Number
Prefix of product code
Sterilisation by Radiation
Sterilisation by Ethylene Oxide
Single Use Product