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

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.IMPLICATIONS FOR REHABILITATIONOccupational 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.