1. Borderline Medical Devices Covered in EU Manual Update
With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly common. Indeed, many questions have been raised about borderline medical devices. In such cases, the intended purpose of the app and the medical benefit to a patient must be carefully reviewed in making the classification decision.This document lists decisions and rationale on medical device classification of borderline cases where there is difficulty in interpreting the rules, and serves as a useful tool in understanding the interpretation of medical device classification rules.