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How are we Regulated?

Regulatory Framework

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 0120 identifies SGS UK, 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.

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 UK 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 three years with absolutely no prior notice given.

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

MHRA (Medicines and Healthcare products Regulatory Agency)

Our Notified Body, SGS UK Ltd, is also strictly governed and assessed 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.

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