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

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 raised concerns regarding implementation in daily practice. To facilitate the MDR implementation, forms were created and evaluated for a selected design case together with the participants for future reference. Additionally, instructions were given which forms should be filled out only once per organization, which forms could be reused for similar types of custom-made devices, and which forms should be filled out for each individual custom-made device. This study provides practical guidelines and forms to support occupational therapists in the Netherlands to prescribe and manufacture custom-made medical devices complying with the MDR. It is recommended to involve engineers and/or quality managers in this process. Occupational therapists are considered legal manufacturer when they prescribe and manufacture custom-made medical devices for their clients. As such they are legally obliged to meet the Medical Device Regulation (MDR).When designing and manufacturing “in-house” custom-made medical devices, care organizations need to follow and document activities to demonstrate compliance with the MDR. This study offers practical guidelines and forms to facilitate this. Occupational therapists are considered legal manufacturer when they prescribe and manufacture custom-made medical devices for their clients. As such they are legally obliged to meet the Medical Device Regulation (MDR). When designing and manufacturing “in-house” custom-made medical devices, care organizations need to follow and document activities to demonstrate compliance with the MDR. This study offers practical guidelines and forms to facilitate this.