Affiliations: Devices for Dignity Healthcare Technology Co-operative, Medical Imaging and Medical Physics, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK. Tel.: +44 114 2713138; Fax: +44 114 2713403; E-mail: [email protected] | University of Sheffield, School of Health & Related Research (ScHARR), Sheffield, S1 4DP, UK
Abstract: The paper describes the European regulatory framework as it relates to the developers and manufacturers of assistive technologies. It uses the context of a UK-based collaborative healthcare technology co-operative “Devices for Dignity” to provide three representative case studies to aid understanding of, and routes through, the regulatory systems. It discusses when and which European Directives apply to assistive technologies, recent changes to the medical devices directive, where to find information on standards, and ethical and regulatory influences on user-centred design. Despite the hurdles, the paper concludes that in the main, the regulatory framework is enabling for the users and manufacturers of assistive technologies rather than being disabling.
Keywords: Medical device, standards, regulations, ethics
