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Medical devices and CE marking in Health Village

A medical device can be, for example, equipment or software that is used in patient care and in support of treatment decisions.

HUS uses an ISO13485-certified quality management system that is crucial for the manufacture of medical devices. Issued by a certification body, the certificate demonstrates that the quality management system of HUS Group meets the requirements set for the manufacture of medical devices. Furthermore, the certificate guarantees that the devices are designed and manufactured according to applicable quality standards. HUS produces ICT services for Health Village.

In Health Village, CE-marked medical devices are the Omapolku® service and the Omapolku mobile app. The following digital Omapolku pathways are classified as medical devices: HUS online therapy, HUS care pathway for people with a fear of childbirth, and HUS neuropsychological online rehabilitation.

Another service classified as a medical device in Health Village is the autism spectrum disorder screening survey. The survey is intended for children aged between 1 year and 4 months and 2 years and 6 months.

There are many types of medical devices. For example, equipment, software, tools, tests or AI-assisted solutions can be medical devices. The intended use of the device, specified by the manufacturer, determines whether it is a medical device. The use of the device must meet any requirements specified by law. A medical device is a device intended for the diagnosis, treatment or follow-up of diseases or injuries, for example.

The CE marking indicates that a device fulfils the requirements set for medical devices by law and authorities. Obtaining the marking and attaching it to the device is the responsibility of the manufacturer – the user does not have to verify the process. The CE marking must be visible on the device, the packaging and the instructions for use. In the Omapolku® service, the CE marking is shown at the bottom of the page after the user has logged in.

Medical devices bearing the CE marking available on the EU market are recorded in the Eudamed database.

Medical devices facilitate the diagnosis, treatment and follow-up of diseases, making them critical for the healthcare sector.

In the EU, the medical device sector is highly innovative and competitive with over 500,000 distinct devices on the market. Regulation ensures patient safety and supports the development of this diverse sector, in which small and medium-sized companies play a key role. The sector is important for both healthcare and the EU economy.

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Updated 22.12.2025

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