Hospitals that produce custom-made medical devices (using 3D printing) fall under the European Medical Device Regulation (MDR). Due to the complexity of the regulation, it’s difficult for healthcare services to ensure they are compliant – complexity around this regulation is even exacerbated when it comes 3D printed medical devices.
To address this issue, Qase3D joined forces with Waveland European Lawyers to introduce an MDR Management System for hospital-based Point-of-Care (PoC) 3D printing labs.
Qase3D helps medical 3D printing teams move from clinical innovation to efficient quality management and regulatory assurance.
Qase3D explains on its website that the system has been developed by European Lawyers who have thoroughly analysed and interpreted the MDR, translating it into a clear, practical framework. This means you can work confidently and compliantly, without having to interpret the regulation yourself. Where the MDR is often seen as vague, this system makes compliance practical, structured, and verifiable.
As explained in this article on “Approval of medical 3D printed products and their market access”, ISO 13485 is widely regarded as the global benchmark for quality management in the medical device industry. However, its breadth can prove disproportionate for smaller manufacturers, including hospital-based point-of-care (PoC) laboratories.
At the same time, the standard falls short of addressing all requirements set out in the European Medical Device Regulation (MDR), requiring ISO 13485–certified organizations to undertake additional measures to achieve legal compliance. In practice, ISO 13485 often imposes a more extensive quality framework than what is required for custom-made devices under the MDR, while still leaving certain MDR-specific obligations unaccounted for.
By transforming European medical device legislation into practical, operational frameworks, Waveland and Qase3D help ensure MDR compliance specifically for custom-made devices, rather than for mass-produced medical products.
Waveland created the online platform that powers the MDR Management System, while Qase3D assists hospitals throughout onboarding, initial implementation, and annual compliance audits. The MDR Management System—available for €990 per year—is purpose-built for Point-of-Care settings and tailored to the unique needs of custom-made devices.
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