Youwell is certified under MDR Class IIa

Youwell Platform is now a CE-marked Class IIa medical device under the EU Medical Device Regulation (MDR). The MDR certification was carried out by the notified body TÜV SÜD.

What does Class IIa mean?

The MDR divides medical devices into risk classes. In Class IIa, it is not enough for the manufacturer to declare for itself that the requirements are met. An independent notified body has audited both the quality system and the technical documentation, and we are under continuous surveillance for as long as the certificate is valid. This places significantly stricter requirements on documentation, risk management and quality management than apply to ordinary software.

A certified platform, not just one app

The certification covers the platform itself, including the authoring tool. Health organisations can therefore build, deliver and follow up their own digital patient pathways within certified frameworks, with Youwell as the responsible manufacturer. You build with the platform's modules, within the intended purpose, and do not need to become a medical device manufacturer yourselves in order to start using digital treatment tools.

Responsibility is clearly divided. Youwell holds the manufacturer's responsibility for the platform. The health organisation holds the clinical responsibility for the choice of content, target group and follow-up of patients.

This has been a long and demanding journey for a small company, and I am incredibly proud of the team that has seen it through. For the health service, it means you no longer have to choose between flexibility and regulatory safety. Health professionals can build for themselves, on a platform that is certified.

- Øyvind Grimsgaard, CEO of Youwell

What does it mean for you?

If you already use Youwell, the platform you use today is now a certified medical device. You get the peace of mind without switching solutions, and we will be in touch about the practicalities.

For buyers and in tender processes, the certification is documented assurance. The certificate, declaration of conformity and instructions for use (IFU) are available on request.

The certification comes on top of eleven years of operation. Youwell is used today by all health trusts in Norway and by more than 200 health organisations in the Nordics, and the platform is available in Norway, Denmark, Sweden and Germany.