MDR Class IIb is not a higher score. It is a risk profile - and that is why it suits LynX Med Flow
When a medical system receives an MDR classification, it is quickly read as a kind of quality label. That picture is not entirely accurate. MDR classes tell you something about what is at stake at the moment the system does something - or fails to do something.
Why LynX Med Flow falls under Class IIb
For medical device software, the MDR class is determined on the basis of two elements:
(1) what the software does, namely providing information for a diagnostic or therapeutic decision, or monitoring physiological parameters
(2) how serious it is if things go wrong
Purely informative or administrative software falls outside the MDR. LynX Med Flow processes and routes alarms to the right healthcare professional. In doing so, the software monitors physiological parameters that can have a serious impact on the patient’s health condition. A delayed or wrongly routed alarm can have direct consequences. That is exactly why we are certified Class IIb.
To obtain that certificate, LynX Med Flow underwent a clinical evaluation and an audit of its quality management system by a notified body - a process that thoroughly scrutinised the safety, risk management and clinical performance of the system.
What this means in practice for a care organisation
For a hospital or care organisation, this certification does not translate into a certificate on a website, but into guaranteed safety, risk management and clinical performance. That robustness also has a second effect, one that reaches beyond LynX Med Flow alone: it gives other medical parties the confidence to enter into integrations with it. As a result, LynX Med Flow does not remain an isolated solution, but can grow further into an open ecosystem across the entire care organisation.
