Current Questions….
- What should the CE mark look like?
- Where should the CE mark go?
- What should be the contents of the Technical File?
- Where should the name and number of the Notified Body appear?
- Do products have to be tested to the European Standard?
- Is the involvement of a notified body required for a Category 1 product?
- How do I certify a product where there is no European Standard?
- Is a site visit required for Article 11A?
- Is CE certification still valid when the product standard used is superseded?
What should the CE mark look like?
The CE mark consists of the initials "CE" in the form as shown below.
For category 3 (complex design) products, the initials "CE" shall be followed by the identification number of the notified body involved in the production control phase, reference Article 11 of the PPE Directive.
The various components of the "CE" marking must have substantially the same vertical dimension, which shall not be less than 5 mm. This minimum dimension may be waived for small scale PPE. The "CE" marking may be of any colour provided that it is clear and legible, and is not likely to be confused with any other marking.
Where should the "CE" mark go?
The "CE" marking must be affixed to each piece of manufactured PPE so as to be visible, legible and indelible throughout the expected life of the PPE. If this is not possible due to the characteristics of the product, the "CE" marking may be affixed to the packaging.
What should be the contents of the 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).
- 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.
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 product;
- 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.
Where should the name and number of the notified body appear?
The name, address and identification number of the notified body responsible for the EC type examination shall be included in the User Information notice supplied with the product.
Is a site visit required for Article 11.A ?
A site visit for assessment purposes is not required. However, a visit will have to be undertaken by the Notified Body to select samples for audit testing.
How do I certify a product where there is no European (EN) Standard ?
Where there is an absence of an European (EN) Standard, the PPE models can undergo EC Type Examination against a Technical Specification put forward by the manufacturer. However, this must then be reviewed by the Notified Body to ensure that the basic health and safety requirements of the PPE Directive are met. If all this is satisfactory and the PPE models can be tested against the Technical Specification then the process would continue in the normal way.
Is the involvement of a Notified Body required for a Category 1 (Simple Design) product ?
EC Type Examination is not required in the case of PPE models of simple design (Category 1). The designer assumes that the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.
Do products have to be tested to the European Standard ?
Where there is an absence of an EN the PPE models can undergo EC Type Examination testing against a Technical Specification put forward by the manufacturer. However, this must have been satisfactorily reviewed by the Notified Body as meeting the basic health and safety requirements of the PPE Directive. Obviously, this is also subject to a recognised independent test house being able to test against the requirements of the Technical Specification being put forward.
Where there is an EN standard but the manufacturer chooses not to comply or only partially complies with that standard, the reasons for so doing must be stated and justified by the manufacturer. The validity of this justification shall be assessed by the notified body.
Is CE certification still valid when the product standard used is superseded?
Once a certificate is issued, that certificate remains valid while the product remains unaltered and the PPE Directive remains unchanged.
Changes to the product standard do not affect the certification unless it can be shown that the original standard did not cover all the Basic Health and Safety Requirements (Annex II) of the PPE Directive.
Although changes to the standard do not invalidate the certification, manufacturers should take note of any changes and consider the implications for their product.
The position regarding modifications to a product certified against a superseded standard is in the process of being clarified.
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