Quadro normativo

The regulatory framework for contact lenses

Contact lenses are a medical device and like all medical devices being sold on the European market, daysoft lenses must carry the CE Mark.

This can be seen with the symbol 'CE' followed by a number, in our case, 0120, representing the Notified Body which performs Audits on Daysoft on a regular basis. In our case our Notified Body is SGS UK Ltd.

The chart below shows the framework in which Daysoft Limited, as manufacturer, operates.


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 process 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 UK Ltd on a regular basis:

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

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

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

MHRA (Medical and Healthcare products Regulatory Agency)

Our Notified Body, SGS UK Ltd, are also strictly governed and assesses by the MHRA which is an executive department of the Department of Health in the UK.

EU Commission 

The MHRA operate under the guidelines and recommendations of the EU Commission.

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

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

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.