Article 2
For the purposes of this Regulation, the following definitions shall apply: (1) ‘instructions for use in electronic form’ means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through a software or a website; (2) ‘professional users’ means persons using the medical device in the course of their work in the framework of a professional healthcare activity; (3) ‘fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a specific location in a health institution so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare institution.