The obvious place for First Aid

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:

fig5

 

 

 

Date of Manufacture

 

fig2

 

 

 

Expiry Date

 

fig3

 

 

 

Lot / Batch Number

 

fig30

 

 

 

 

Contains Latex

 

fig11

 

 

 

 

Prefix of product code

 

fig8

 

 

 

 

Sterilisation by Radiation

 

fig7

 

 

 

 

Sterilisation by Ethylene Oxide
fig1
 

 

 

Single Use Product

Leave a reply

Your email address will not be published. Required fields are marked *