Certification of Peercode's Atris telemonitoring solution as Medical Device Class IIa under MDR is a fact
Medical devices are classified into four classes: I, IIa, IIb and III. Classification is based on risk: the higher the risk for the patient if the medical device fails, the higher the class. And the higher the class of the aid, the more requirements there are from the legislation (MDR).
Peercode's Atris telemonitoring solution has been certified as Medical Device class IIa (MDR) by Notified Body KIWA.
This makes Atris the only Dutch telemonitoring product with a Class IIa certification. Other telemonitoring solutions are still certified according to the MDD regime (self-certification) as class I Medical Device. In May 2024 the so-called 'grace period' will be over and the MDR rules will apply to all hardware and software products.
Anouk Lahav, Peercode’s Manager Medical Device and Regulatory Affairs: “This is an important step for Atris and for our partners who want a secure, reliable and effective remote patient monitoring solution that will remain state-of-the-art in the future.”