Qase3D, a company focused on regulatory compliance and quality systems for medical 3D printing operations, has partnered with Waveland European Lawyers to introduce an MDR Management System for hospital-based Point-of-Care (PoC) 3D printing labs. The system addresses compliance with the European Medical Device Regulation (MDR) for facilities producing custom-made medical devices, including anatomical models, surgical guides, and patient-specific implants used in clinical settings.
European regulations require manufacturers of custom-made medical devices to implement a Quality Management System that ensures safety, effectiveness, and traceability. ISO 13485 serves as the globally recognized standard for medical device quality management, yet its scope often exceeds the needs of small manufacturers such as hospital PoC labs. At the same time, ISO 13485 does not fully cover all MDR-specific obligations, meaning organizations certified to the standard must still perform additional activities to comply with European law. ISO 13485 encompasses a broader set of quality processes than those required for custom-made devices under the MDR, while leaving certain MDR obligations unaddressed.
Waveland European Lawyers developed the underlying online platform used for the MDR Management System. The legal firm specializes in translating European medical device legislation into operational frameworks. Its platform is already used by podiatrists in the Netherlands, who—like PoC labs—are classified as small medical device manufacturers under the MDR. The system converts regulatory requirements into structured documentation written in plain language. Users progress through 18 chapters containing checklists, forms, and tables related to organizational structure, product classification, and compliance documentation. Completion of all chapters confirms that MDR requirements applicable to custom-made devices have been addressed. Waveland maintains the platform to reflect updates to MDR-related legislation.
Unlike traditional quality systems, this framework focuses strictly on legal requirements defined by the MDR and applies to custom-made devices rather than serially manufactured medical products. Facilities may deploy it as a standalone MDR Management System or integrate it into an existing ISO 13485-based quality framework. Qase3D supports hospitals during onboarding, initial implementation, and annual compliance audits. Drawing on experience with hospital 3D printing operations, the company aligns regulatory documentation with the operational realities of producing patient-specific devices within clinical environments.
Erik Boelen of Qase3D explained the motivation behind the collaboration, stating, “While supporting several PoC labs in building their ISO 13485 QMS, I received more questions about the MDR than about the standard itself. Because the goal isn’t to build a QMS, the goal is to achieve MDR compliance. I discovered that to truly understand the MDR, we need European legal expertise. That search led me to Waveland. Their MDR portal was an eye-opener; I never expected MDR compliance could be achieved so practically.”
Benedikt Marijnen, founder of Waveland European Lawyers, described the legal approach behind the platform. “It’s in my DNA to make complex things simple. With Waveland, we translated the MDR into clear, understandable language and practical actions. Our MDR Management System is recommended by the National Podiatry Association in the Netherlands. Together with Qase3D, we adapted the system so European hospitals can now benefit from the same simplicity when producing custom-made devices at the Point-of-Care.”
MDR compliance ultimately requires that medical devices placed into clinical use meet documented standards for safety and performance. Many PoC teams already operate with this responsibility in mind, but regulatory conformity depends on traceable records and defined processes rather than informal practice. The Waveland platform provides structured documentation intended to support compliance with MDR requirements applicable to custom-made devices, while Qase3D supports hospitals in implementing and maintaining those records within daily production workflows.
For more information about the MDR Management System for PoC 3D labs, visit https://qase3d.com/mdr-poc/.
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Featured photo shows Medical staff review 3D printed anatomical models produced in a hospital Point-of-Care (PoC) lab. Photo via Qase3D.
