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CE regulations for ophthalmic optics products were introduced in June 1998.
Their purpose, set out in European Directive 93/42, is to harmonise national standards for optical products throughout the European Union, through the International Standards Organisation (ISO).
Assurance
Essilor confirms that all the lenses in our product catalogue meet the key requirements defined in European Directive 93/42. Our lenses have been tested and meet all the following criteria:
■ Optical performance
■ Standard EN/ISO 14889, 8980-1 & 2
■ Physiological performance and flammability
■ Standard EN/ISO 14889
■ Static robustness and transmission specifications
■ Standard EN/ISO 14889 and ISO 8980-3
■ Coatings test specifications
■ Standard EN/ISO 8980-4
EC certification mark
The EC certification mark is applied to all Essilor lens packaging. It indicates that the lenses comply with the relevant CE regulations.
Product conformity
Orders from opticians for lenses whose properties (i.e. thickness, tint etc) do not comply with the requirements of Directive 93/42 cannot be supplied. Treatments applied to ophthalmic lenses by the practice or a third party are the responsibility of the retailer and Essilor will not be liable.
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Standard information and restrictions
We are required to provide all the information and restrictions required by Directive 93/42 regarding the correct use of our products. This information should be passed on to your customers. Restrictions on lens usage will appear on our delivery note to act as a reminder.
Glazing
If you glaze or use Easy Fit (remote edge) you are required to register with the Medicines and Healthcare products Regulatory Agency (MHRA). It is an offence not to be correctly registered. The CE regulations prohibit Essilor from glazing any new frames which are not marked with the CE mark, or are not accompanied by a tag or literature which has the CE mark. This does not refer to secondhand frames (so-called re-glazing) where normal quality verification activity will be conducted.
Patient information
Opticians are required to give patients information and advice on the correct use, care and limitations of their lenses. The information required is very specific and makes definite demands of opticians, particularly in terms of the restrictions on use of lenses. Much of it is information that any optician would give patients as a matter of course, but under the Directive, opticians are encouraged to do so systematically.
Driving
Lenses are deemed unsuitable for driving if light transmission is less than 8%, or if the tint affects the perception and recognition of traffic lights. For night driving, transmission should not be less than 80%.
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