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:
- Overall and detailed plans of the PPE accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the basic requirements (Annex II of the PPE Directive). Personal Protective Equipment Directive FAQs 4/4
- An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications used to demonstrate compliance with the basic requirements.
- Declaration of Conformity
Other technical documentation that should be included, although not strictly part of the ‘Technical File’ is:
- A copy of the User Information or Instructions for Use supplied with the equipment
- A description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production PPE with the harmonized standards or other technical specification.
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:
- Mechanical action whose effects are superficial (gardening gloves, thimbles, etc.)
- Cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)
- Risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to dangerous impacts (gloves, aprons for professional use, etc.)
- Atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.)
- Minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.)
- Sunlight (sunglasses)
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.