Glasses are an object of daily use for several people. However, it is important to clarify that their regulatory classification changes depending on their function.
Sunglasses are a personal protective equipment and, as such, they are regulated by Regulation 2016/425 EU.
The technical norm UNI EN ISO 12312-1:2015 is a useful tool for manufacturers for the purpose of the development of these products. This norm applies to afocal sunglasses (no optics nominal power) and clip-ons for general use intended for protection against sun radiation.
On the other hand, it does not apply to sunglasses prescribed by doctors to mitigate sun radiation. These are medical devices.
The norm is also harmonised according to Regulation 2016/425 EU, therefore its application allows the manufacturer to presume the conformity to the affected fundamental requirements of health and safety.
The technical aspects examined in depth by the norm include, for instance:
- power of refraction
- transmittance capacity
- robustness in terms of deformation of the frame and maintenance of optical filters.
Generally, sunglasses belong to risk category I. In fact, the following point of Annex I of Regulation 2016/425 EU laying down the categories of risk against which PPE is intended to protect users.
- (d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
For the purposes of the CE marking, the manufacturer shall follow the conformity assessment procedure regarding the in-house manufacturing control. In this procedure, the intervention of a Notified Body as independent third party is not required. Therefore, no certificate is available for this category.
In details, the manufacturer shall:
- draft the technical Documentation
- take any measures required so that the manufacturing process and its control assure the conformity of the manufactured PPE to the technical documentation and to the applicable requirements of this regulation.
- include the CE marking on each item of PPE meeting the applicable requirements of the present regulation and draft a written declaration of EU conformity.
Eyeglasses, intended to compensate refractive errors, are custom-made medical devices. The tools available for manufacturers to develop these products are the following technical norms, harmonised so far with Directive 93/42/EEC:
- EN ISO 14889:2009 – Fundamental requirements for uncut finished lenses
- EN ISO 21987:2017 – Mounted spectacle lenses
- EN ISO 21987:2009 – Mounted spectacle lenses
- EN ISO 12870:2009 – Spectacle frames – Requirements and test methods
- EN 14139:2010 Ophthalmic optics – Specifications for ready-to-wear spectacles
The optician making custom-made glasses is actually a manufacturer of custom-made medical devices. Among the many activities they are bound to carry out, they shall also register in the list of custom-made medical device manufacturers of the ophthalmic sector using the dedicated forms made available by the Ministry of Health.
For custom-made glasses, the manufacturer shall also draft a declaration including, for instance, the name and address of the manufacturer, the data identifying the concerned medical device and a declaration that the concerned medical device is intended for use by a specific patient, whose name is also reported.
Written by: Antonio Ciriello