Light Therapy|Consumer information

Legal framework of light therapy in the European Union

In EU, light therapy lamps are treated as medical devices (class IIA). Therefore they are subject to the rules and specifications defined by the 93/42/EEC European directive, applicable in all EU member-states. Click on the following link to view the original text of the law on the EU's official web page: europa.eu.int

This law aims at protecting consumers by imposing strict security and quality rules to manufacturers. Accordingly, light therapy devices cannot be distributed in EU unless formally checked (technical tests must be conducted by an independent laboratory) and approved by the health authorities of a member-state. In addition, manufacturers must have a ISO 46003 : 2000 quality certification.

Once a member-state delivers an authorization to a light therapy device, it is valid in the entire EU.

The Finnish National Agency for Medicine (Lääkelaitos), following the conclusions of the tests conducted by VTT Technical Research Center, has approved all Medi-Light lamps as medical devices class IIA.

A copy of the certificate delivered by VTT to Valotaina Oy is available here.

How to recognize a genuine light therapy device

Above all, check who is the manufacturer.

Each officially approved light therapy device manufacturer has its own CE mark (Valotaina's is CE0537). This number must be indicated on the packaging and on the lamp. The validity of this number can be checked from all member-states' health and medicine authorities.

A two-year guarantee and a serial number for each device are the most basic conditions for a light therapy lamp.