Medical device regulation: requirements for occupational therapists in The Netherlands who prescribe and manufacture custom-made devices

PurposeTo interpret the Medical Device Regulation for occupational therapists in the Netherlands involved in prescribing and manufacturing custom-made assistive devices and to develop a roadmap for implementation.Materials and methodsFour online iterative co-design workshops were organized under supervision of a senior quality manager to assist in the interpretation of the MDR framework with a focus on custom-made assistive devices; and to assist the implementation by generating guidelines and forms. The workshops for seven participating occupational therapists had an interactive character wit... Mehr ...