About Dermicus

 

Product Name
Dermicus

Year
2021

Article Number
D3.0-112015

Background
Dermicus is a telemedicine system that is developed by Gnosco AB.

Responsible for the system
Johan Heilborn, Specialist in Dermatology, Medical Officer at Gnosco AB.

Purpose
Dermicus is a clinical decision support for healthcare professionals. The system can be described as a further development of the healthcare’s conventional text-based paper or electronic referrals. Using Dermicus system, the referring party can attach images in addition to text to facilitate better patient care by providing optimal guidance on the clinical management of patients with skin diseases as well as monitoring skin changes over time.

CE-Certification
Dermicus is CE certified according to Class I.
Since 1993, Sweden has a comprehensive legislation, which specifies the requirements of the medical devices that are placed on the market. The basis for this regulation is the Law on medical devices and the regulations were published by the Swedish Medical Products Agency.

Software used for medical purposes must be CE certified. In the Medical Devices Directive (93/42 / EEC), which took effect on 21 March 2010 through amendment Directive 2007/47 / EC, the following formulation for standalone software is used:
”It is necessary to clarify that software is itself a medical device when it is, by the manufacturer, specifically is used for one or several of the medical purposes that are stated in the definition of a medical-technical product. ”

The law on medical devices (1993: 584) is a product type that will ensure that products placed on the market are safe and fit for purpose. The aim is to prevent accidents and incidents by imposing requirements on the products and those who put the products on the market.

2 § A medical device, according to the law, is a product that according to the manufacturer should be used, alone or in combination with others, for humans to

1. detect, prevent, monitor, treat or alleviate a disease.

5 § A medical device shall be suitable for its use. The product is suitable when it

1. is correctly delivered and installed, maintained and used in accordance with manufacturer’s labelling, instructions, or marketing, and

2. achieves the performance intended by the manufacturer and meets high standards for protection of life, personal safety and health of patients, users and others.
It is the manufacturer’s purpose and mechanism of action of a product, and not the design or the user, which determines whether the product is a medical device. As a user, you should be able to expect that the manufacturer has taken into account patient risk and patient benefit in the design of the product.

Reference
1 Författningssamling LVFS 2009:18. Läkemedelsverket 2009-10-08.
2 Vägledning för tillverkare av klass I produkter. Läkemedelsverket 2012-05-31.
Medicinska informationssystem – vägledning för kvalificering och klassificering av programvaror med medicinskt syfte. Läkemedelsverket 2012-11-06.