In May 2020, Medical Device Regulation goes into effect. Digital health companies providing software intended for medical use will need to comply with new requirements. According to Jovan Stevović, CEO and Co-Founder of Chino.io, companies are much better prepared for MDR than they were for GDPR. In general, medical devices are products or equipment intended for medical use. These include long-term corrective contact lenses, surgical lasers, defibrillators, hearing aids, diagnostic ultrasound machines, hip-joint implants, prosthetic heart valves. There are three classes of medical devices: Class 1, Class 2a and 2b, and Class 3. The classification depends on the intended use. Medical devices class I have the lowest perceived risk for health, those in Class 3 the highest. MDR also defines software which is designed for medicinal purposes, to be a medical device.

 

Recap of the show: www.facesofdigitalhealth.com/blog/f062-gdpr-mdr-and-what-you-can-do-about-you-medical-data-jovan-stevovi

Chino.io: https://www.chino.io/

Free eBook: How to build MDR certified eHealth applications: https://www.chino.io/a/chino-io-ebook-medical-device-regulation-ehealth-applications