Updated EU Manual on Borderline: new instructions for app classification

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’

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The EU has just updated the ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’.

The new version of the Manual contains standards for qualification of APP and Software as a DM.

At the first, the manual refers to principles of MEDDEV Guidance 2.1 / 6 Entitled Guidelines on the qualification and classification of stand-alone software used in healthcare Within the Regulatory Framework of Medical Devices

Regarding APP classification, the suggested  principles  are:

 (1) an app for ECGs processing, to allow more timely and accurate diagnosis and treatment, which the EC considers a class IIa device;

(2) an app for data storing on contractions to improve the quality of communication, which is not considered a medical device;

(3) an app designed to view illustrations of the human anatomy with no direct medical benefit to the patient, which is not considered a medical device.

As we known, the EU provisions on Borderline Manual are just indicative criteria.

After the judgment by the Court of Justice on the case “C-109/12 - Laboratorie Lycocentre”,   the Member States shall maintain some ??indipendence in the product classification as medical devices.