Medical Device Regulation Compliance
CE Marking & Classification
7 Lens prescription glasses are Class I medical devices under EU Medical Device Regulation (MDR) 2017/745. Each pair of glasses bears the CE marking, indicating conformity with applicable EU health, safety, and environmental requirements. The CE marking is affixed to the frame or included in the packaging documentation.
Applicable Standards
Our lenses and frames comply with the following harmonized European standards: EN ISO 14139 (Ophthalmic optics — Spectacle frames), EN ISO 12870 (Ophthalmic optics — Spectacle frames — Requirements and test methods), EN ISO 21987 (Ophthalmic optics — Mounted spectacle lenses), and EN ISO 14889 (Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses).
Manufacturer Information
7 Lens is a brand operated under applicable EU regulations. The manufacturer of the medical device (prescription glasses) is the optical laboratory that cuts, edges, and mounts the lenses into the frames according to the prescription provided. The manufacturing process follows ISO 9001 quality management standards. Each production batch is documented and traceable via the order number.
Intended Use
Prescription glasses sold through 7 Lens are intended for the correction of refractive errors (myopia, hyperopia, astigmatism, and presbyopia) as determined by a licensed eye care professional. They are not intended for the treatment, diagnosis, or prevention of any eye disease. The prescription must be provided by the user and verified by our qualified staff before the order enters production.
EU Authorized Representative
In compliance with MDR Article 15, our EU authorized representative is responsible for ensuring ongoing conformity with regulatory requirements. Contact support@7lens.eu for the current authorized representative details. Serious incidents involving our products should be reported to both 7 Lens and the competent authority of your EU member state.
Contraindications & Side Effects
Contraindications
Prescription glasses should not be used: (1) as a substitute for regular comprehensive eye examinations by a licensed optometrist or ophthalmologist; (2) for the treatment or management of any eye disease, injury, or condition requiring medical supervision; (3) in situations where the user experiences sudden vision changes, eye pain, or other acute ocular symptoms — seek immediate medical attention instead.
Possible Side Effects
When first wearing new prescription glasses, some users may experience: mild headaches, eye strain or fatigue, a sensation of altered depth perception or spatial distortion, mild dizziness or vertigo, and peripheral vision blur. These effects are typically temporary and resolve as your visual system adapts, usually within 2-7 days of consistent wear.
When to Stop Use
Discontinue use and consult your eye care professional immediately if you experience: persistent headaches lasting more than 7 days, double vision (diplopia), severe eye pain, significant visual distortion that does not improve, nausea or vomiting associated with wearing the glasses, or any signs of allergic reaction to frame materials (rash, swelling, itching around contact areas).
Important Precautions
(1) Prescription glasses are custom-made for the individual user and must not be shared with others. (2) Incorrect pupillary distance (PD) measurement can cause significant visual discomfort. Always use the PD value provided by your optometrist. (3) Children's prescriptions should be rechecked every 6-12 months as their vision changes rapidly. (4) Do not use prescription glasses for driving or operating machinery until you have fully adapted to them. (5) High-index lenses may cause more noticeable chromatic aberration (color fringing) in peripheral vision — this is a normal optical property, not a defect.
Reporting Adverse Events
If you experience any serious adverse event related to our products, please report it to us immediately at support@7lens.eu. In accordance with EU Medical Device Regulation 2017/745, serious incidents should also be reported to the competent authority of your EU member state. We maintain a post-market surveillance system and will investigate all reported incidents.