Accreditation

BIOSUN Earcandles are a class IIa medical device as described in the German Medical Devices Law.

Earcandles are used as an independent therapy and to accompany other therapies to treat certain symptoms in the health sector. When used in the beauty and wellness sector, the deep relaxing effect of the Earcandles is used to improve general wellbeing.

Based on the German Medical Devices Law and the European Medical Devices Directive, BIOSUN Earcandles are certified as a medical product. Earcandles in general were classed as a class IIa, active, non-invasive medical device in 2003 by a project group of the "Länderarbeitsgruppe Medizinprodukte“ (Medical devices working group).

The necessary accreditation is proven through the "CE label" in conjunction with the four-digit identification of the certifier; for BIOSUN this is EUROCAT.

Furthermore, products that are sold as medical devices require product documentation and a clinical assessment. In the case of class IIa medical devices, such as Earcandles, this clinical assessment is used as a risk assessment and is verified by the local regional council. During the last inspection in August 2008, the Gießen regional council came to the conclusion that BIOSUN Earcandles qualify as a medical device.