Medical Device Regulation (MDR)
From 26th May 2021, Medical Device Regulation will be law throughout the EU. It is a standard for medical devices based upon its predecessor, the Medical Device Directive, but what does this mean for AAC? MDR is relevant for us due to this clause:
"Medical Devices means any instrument, apparatus, appliance, software…. or other article intended to be used for the diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability."
This means that assistive technology now falls under the definition of Medical Devices, and we must therefore comply with these guidelines.
What does it mean for you?
If you're a user, don't worry! There's no action you as a user need to take. Our products won't be changing aside from some minor product labelling changes - the functionality and look of the apps you use will remain the same.
Do we have EU distributors and resellers? - don't have? rehavista?
Info about EU rep?