This resource is the official English version of EU Decision No 768/2008/EC, one of the core documents of the EU’s New Legislative Framework (NLF).
About this document
The Decision provides a common framework for EU harmonisation legislation on products, setting out the conformity assessment modules (Modules A–H), the principles for using the CE marking, and the obligations of economic operators such as manufacturers, authorised representatives, importers and distributors. The MDR, IVDR and many CE directives and regulations – such as those on machinery, low voltage and electromagnetic compatibility – are modelled on it.
Applicable products and users
- All products that must bear the CE marking to enter the EU market
- Companies wishing to understand CE conformity assessment modules and economic operator responsibilities
Main contents
- Definition and selection of conformity assessment modules (Modules A–H)
- General principles of the CE marking
- Division of obligations among manufacturers, authorised representatives, importers and distributors
- General requirements for notified bodies
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Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.