Regulatory FAQ.
Clear answers, clear perimeter.
A practical page for partners, facilities and stakeholders who need to understand what AgeVision claims, what it does not claim and why intended purpose matters.
Is AgeVision CORE a medical device?
No. The website does not claim autonomous diagnosis, therapeutic decision-making or clinical prediction.
Why is AgeVision CORE in Class I?
Under EU MDR, software classification depends strongly on intended purpose. Software providing information used for diagnostic or therapeutic decisions may fall into higher classes depending on the significance of those decisions.
Is avoiding certain words enough to stay compliant?
Yes, but any new intended medical function must be assessed before release. Product development cannot rely on marketing language alone to preserve a classification.
Does AgeVision make diagnoses?
No. It is presented as an informational multidimensional synthesis and does not replace professional judgement.