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What does CE Mark on products mean?

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






Expiry Date






Lot / Batch Number







Contains Latex







Prefix of product code







Sterilisation by Radiation







Sterilisation by Ethylene Oxide



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