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There are general requirements for all 3 classes, including technical documentation,
a CE mark and a Declaration of Conformity.
The manufacturer must create a technical file.
The Technical File shall consist of:
Other technical documentation that should be included, although not strictly part of the ‘Technical File’ is:
If the equipment is to be manufactured in series, an EC type-examination is required. This EC type declaration shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerning the effects of which, when they are gradual, can be safely identified by the user in good time. This category shall cover exclusively PPE intended to protect the wearer against:
In the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm health, the PPE will be subject to either “EC” quality control system for the final product or system for ensuring EC quality of production by means of monitoring and to an EC Declaration of Conformity.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the equipment.