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.

An interesting update in this most recent revision includes classification decisions in relation to mobile apps. An app used to enable clinicians to review a patient’s ECG during routine check-ups, to allow for more timely and accurate diagnosis of the patient, was determined to be Class IIa as per Rule 10 of the Medical Device Directive.  It was determined that an app for communication of data to caregivers on a mother’s contractions during delivery, and an app for viewing the anatomy of the human body should not to be classified as medical devices.The full text of the manual is available at the following link:

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