‘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;

‘professional users’ means persons using the ►M1  ————— ◄ device in the course of their work in the framework of a professional healthcare activity;

‘fixed installed devices’ means devices 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.

the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;

they shall provide instructions for use in electronic form in all Member States where the product is made available or put into service unless duly justified in the risk assessment referred to in Article 4;

they shall have a system in place to provide the instructions for use in paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;

they shall provide, on the device or a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device;

they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect;

for ►M1  ————— ◄ devices fitted with a built-in system visually displaying the instructions for use, they shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular, life-monitoring or life-supporting functions;

they shall provide, in their catalogue or other appropriate device information support, information on software and hardware requirements needed to display the instructions for use;

they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;

for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for users in electronic form for 10 years after the last device has been placed on the market and at least 2 years after the end of the expiry date of the last produced device;

for devices without a defined expiry date and implantable devices, they shall keep the instructions for use available for the users in electronic form for 15 years after the last device has been placed on the market;

the instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available ►M1  ————— ◄ ;

during the periods set out in points (9) and (10), all issued electronic versions of the instructions for use and their date of publication shall be available on the website or, as regards versions that are obsolete, be made available upon request.