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Instructions for use of ibiz products7/11/2023 ![]() ![]() ‘Fixed installed medical devices’ means devices and their accessories which are intended to be installed, fastened or otherwise secured at a special location in a healthcare facility 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 facility. ‘Professional users’ means persons using the medical device in the course of their work and in the framework of a professional healthcare activity. ‘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 instructions for use available through a website. ‘Instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken as outlined in the relevant parts of point 15 (Part III of the UK Medical Devices Regulations 2002, Annex I(15) ) and of point 13 of Annex I (Part II of the UK Medical Devices Regulations 2002, Annex I(13) ). There is even a suggestion that electronic instructions for use could improve levels of safety, given that electronic storage of information is less susceptible to loss, providing that sufficient safeguards are used. The provision of instructions for use in an electronic form can be beneficial for certain professional users and the purpose of Regulation 4J is to reduce the environmental burden and improve competitiveness by reducing costs whilst at the same time maintaining safety. Regulation 4J of the Medical Device Regulations 2002 on electronic instructions for use of medical devices allows manufacturers of certain types of medical devices and accessories to provide electronic instructions for use if they wish, and lays down requirements that have to be met in order for this to fulfil the requirements of the medical device regulatory system.
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