The European Commission has published a revised version of its Guidelines on Qualification and Classification of Stand-Alone Software ("MEDDEV 2.1/6"), which replaces the earlier 2012 version. The changes are limited, with the key change being in the definitions section. The guidance now contains a definition of "software": a "set of instructions that processes input data and creates output data." The guidance also introduces definitions of "input data" and "output data." The new definition of software is used in the new question in decision node 1 in the Medical Devices Directive flow chart ("Is the product a software according to the definition of this document?"). The new MEDDEV version also clarifies that "the criteria specified in this document apply also to mobile applications"; however, it was hoped that the Commission would use this opportunity to provide additional guidance on mobile applications that fall within the classification of medical devices.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
