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.

本研究旨在为荷兰参与定制辅助器具处方与生产的职业治疗师解读《医疗器械法规》（Medical Device Regulation，MDR），并制定落地实施路线图。研究团队在一名高级质量经理的指导下，组织了四场线上迭代协同设计工作坊，以协助解读MDR框架（重点聚焦定制辅助器具领域），并通过制定指南与表单助力法规落地。
面向7名参与的职业治疗师的工作坊采用互动式形式，包含问答环节、分组作业、课后任务与口头评估。除职业治疗师外，参与人员还涵盖多背景专业人士，包括3D打印专家、工程师、管理人员与研究人员。
参与者反馈，MDR的解读内容兼具实用性与复杂性。遵守MDR要求需开展大量文档编制工作，而此类工作目前并未纳入护理专业人员的日常职责范畴，这最初引发了从业者对日常实践中落地该法规的担忧。
为推进MDR落地，研究团队与参与者针对一个选定的设计案例共同开发并评估了相关表单，以供后续参考。此外，还明确了各类表单的适用场景：部分表单仅需机构一次性填报，部分可复用至同类定制器具的制作流程，其余则需为每一件定制器具单独填写。
本研究提供了实用指南与配套表单，可助力荷兰职业治疗师为服务对象处方并生产符合MDR要求的定制医疗器械。研究建议，该流程中应邀请工程师及/或质量管理人员参与。
职业治疗师为服务对象处方并生产定制医疗器械时，会被认定为合法制造商，因此依法需遵守《医疗器械法规》（MDR）。在“内部自制”定制医疗器械的设计与生产过程中，护理机构需遵循相关要求并留存活动记录，以证明其符合MDR规定。本研究提供的实用指南与表单，正是为了助力这一合规流程。职业治疗师为服务对象处方并生产定制医疗器械时，会被认定为合法制造商，因此依法需遵守《医疗器械法规》（MDR）。在“内部自制”定制医疗器械的设计与生产过程中，护理机构需遵循相关要求并留存活动记录，以证明其符合MDR规定。本研究提供的实用指南与表单，正是为了助力这一合规流程。