To 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. Four 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 with Q&A, small and homework assignments, and oral evaluations. Next to occupational therapists, participants with different backgrounds joined such as 3D printing experts, engineers, managers, and researchers. The participants experienced the interpretation of the MDR as informative, but also as complex. Complying with the MDR requires considerable documentation activities that are currently not part of care professionals tasks. This initially ...