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How are we regulated?

Regulatory framework for contact lenses.

Contact lenses are a medical device, and like all medical devices sold on the European market, daysoft lenses must carry the CE Mark. The Daysoft mark CE 1639 identifies SGS Belgium, as the Notified Body which audits Daysoft. daysoft lenses also carry Health Canada Approval (License #61427). The chart below shows the framework in which Daysoft Limited, as manufacturer, operates.

Regulatory Framework

ISO 13485 Quality System

All daysoft lenses are manufactured under the control of a certified Quality Management System, compliant with BS EN ISO 13485:2016. All processes in the manufacture of our lenses are completed under one roof at our plant in Scotland.

CE Marking

Additional requirements of the European Medical Devices Directive (93/42/EEC) have also been implemented, maintained and assessed to allow our lenses to be CE marked.

SGS Audits

As mentioned above, Daysoft is subject to Audits by SGS Belgium Ltd on a regular basis:

SGS Surveillance audits are carried out annually to ensure ongoing compliance to BS EN ISO 13485:2016. Among the things checked in the audit is the effectiveness of the sterilisation process. This is obviously critical for something that is to be inserted in the eye.

Daysoft will be subject to an unannounced Audit by SGS a minimum of once every five years with absolutely no prior notice given.

Re-certification Audits are a more in-depth audit which takes place every three years.

FAMHP (Federal Agency for Medicines and Health Products)

Our Notified Body, SGS Belgium Ltd, is also strictly governed and assessed by the FAMHP which is the Federal Agency for Medicines and Health Products located in Belgium.

EU Commission 

FAMHP operate under the guidelines and recommendations of the EU Commission.

Money-back promise

Both of our lenses are available at the same unbeatable price and every purchase is backed by our no quibble money back promise. This means you can try daysoft® lenses and if you aren't happy with your purchase you'll receive a refund.

daysoft® lenses

daysoft in SILK solution

SILK solution is an enriched saline solution for enhanced comfort and moisture throughout the day

SILK contains the eye’s natural lubricant, Hyaluronan, which can hold up to 1,000 times its weight of water, keeping your eyes moist all day

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daysoft in CLASSIC solution

CLASSIC solution is a simple saline solution, with no added moisturisers

CLASSIC solution can be particularly beneficial to allergy sufferers and people with sensitive eyes

 

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