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Knowing the PPE Directive
Companies involved in the supply of PPE into Europe need to ensure their products comply with the requirements of the PPE Directive before they can apply the CE mark.
The CE mark enables free movement of goods throughout the EU and, therefore, is an important element of trade. In fact, most buyers of ‘Intermediate’ or ‘Complex’ PPE will not consider purchasing without seeing a copy of the EC type examination certificate issued by a Notified Body to show that initial samples are compliant.
However, not all types of PPE need to be submitted to a Notified Body. ‘Simple’ category PPE (products designed to only protect against low level hazards – defined in a list within the PPE Directive) can be ‘self certified’. Manufacturers are obliged to produce a ‘Technical File’ – the documentation relating to the product and covering areas such as markings, instructions for use, warnings and design criteria – as well as confirming any performance claims made. Even at this level, buyers should ask for some confirmation that products satisfy the PPE Directive (which ‘Simple’ items must do).
EC Type Examination
It is a mandatory requirement for suppliers of ‘Complex’ and ‘Intermediate’ design PPE to have initial examples of their products assessed by a European Notified Body such as SATRA. This process is called EC type examination and is a check on the design and documentation of a prototype or initial example of an item of PPE to ensure that it is fit for its intended use and satisfies the Basic Health & Safety Requirements of the Directive. This process is based on the claims made about the product in the user information and is achieved by:
1. Examining the design documentation (referred to as the Technical File) to ensure that firstly, the product satisfies all the relevant sections from the list of basic health and safety requirements given in Annex II of the PPE Directive. Secondly that the product is adequately described through the use of diagrams and lists giving the source of all materials.
2. Carrying out a series of tests and examinations on the products to ensure they meet the claimed performance levels. This may be harmonised European standards or alternatively, if required, the manufacturer and Notified Body can use an agreed technical specification. The test reports are then added to the technical file. If EC type examination is successful, a certificate is issued by the Notified Body to prove conformity. For intermediate products, this is effectively the end of the Notified Bodies involvement and the certificate holder becomes responsible for ensuring that subsequent production remains the same as the model examined by the Notified Body.
In addition to initial type examination of the prototype model, “Complex” design PPE is subject to checks by a Notified Body to ensure that production versions of the PPE continue to comply with the initial sample previously approved by the EC type-examination. It should be noted, however, that the Notified Body that carries out the Article 11 assessment need not be the same as the Notified Body that carried out the original type approval.
The manufacturer or authorised representative can choose one of two alternative methods for the Notified Body to use when checking the conformity of ongoing production:
Article 11A (Product Monitoring) – This involves the Notified Body selecting and removing a random sample of manufactured items of PPE which are then tested by methods used in the original EC type-examination to ensure continuing compliance.
Article 11B (Quality System Monitoring) – This involves visiting the manufacturing site and checking that the quality systems used by the manufacturer are capable of enabling consistent production of the certified product. SATRA uses qualified IRCA (International Register of Certified Auditors) registered quality management system auditors for this work.
Both Article 11A and 11B assessments are carried out on a regular basis while that item of PPE remains in production.