Medical devices and CE marking in Health Village

A medical device is a CE marked software or equipment whose product development process requires compliance with the quality system. A medical device can be used in patient care or in support of treatment decisions with the help of an algorithm or AI, for example.

Despite their name, medical devices are not always devices, but they can also be software that is used in patient care and in support of treatment decisions, for example, with the help of an algorithm or AI. Medical devices are manufactured to replace the work of nurses and doctors, as well as help patients or citizens search for information and receive self-help instructions online.

One example of a medical device is a symptom navigator, which provides instructions for seeking a doctor and information on conditions that can be treated at home, as well as helps with diagnosing ailments. Doctors may use medical devices to help them determine a diagnosis or make treatment decisions.

In the future, medical devices that can be used by both patients and healthcare professionals will likely enter the market. These medical devices will, for example, make diagnoses using image analysis or guide patient care by personalising it to best suit the patient.

One of the objectives is to reduce the workload of nurses. This can be aided with chat bots or patient questionnaires at regular intervals, which enable the nurses to react and provide instructions to the patient whenever necessary. It saves time and money when nurses do not need to be in contact with all the patients.

CE marking confirms that the manufacturer's device meets the relevant requirements.

The manufacturer determines the requirements and risks, and the product is designed according to them. The quality and risk management of the product are grounded on the manufacturer's expertise. CE marking is a declaration that the product has been manufactured according to the standards of medical devices.

The finished product is registered in EUDAMED, which is an EU-wide database of medical devices, their manufacturers and suppliers.

The responsibility of the manufacturers of medical devices covers the entire life span of the product, starting from its design and ending to its removal from the market.

There are various kinds of operators in the market, which is why the regulations have become stricter since May 2021. This was done to ensure that the software products used by citizens and healthcare professionals were appropriate.

The ISO 13485 quality system is related to healthcare devices, equipment and software. The system reduces risks and improves patient safety when developing healthcare devices.

The virtual team working on software product development at HUS Group’s Health Village received its ISO 13485 certification in summer 2018. The certification applies to algorithms, AI and machine learning, as well as applications and systems utilising data analytics in social and health care.

The certification proves that HUS is committed to high quality and that its quality system complies with the regulatory requirements. The certification was granted by Inspecta Sertifiointi Oy.

Some of Health Village’s services that are classified as medical devices (as in, they have a CE marking) include My Path/My Path mobile and the Modified Checklist for Autism in Toddlers. My Path comprises of various digital care pathways, some of which are classified as medical devices. The Modified Checklist for Autism in Toddlers can be used to evaluate the likelihood of an autism spectrum disorder in toddlers.

The following Health Village applications have a CE marking: