The Advanced Technologies in Design and 3D Printing Unit (UTADI 3D) at Hospital Universitario 12 de Octubre in Madrid has become the first public unit in Spain to hold a dual manufacturing license and dual certification, one for design, one for manufacturing, for each family of custom medical devices. The recognition follows an expansion of the unit’s manufacturing license and the scope of its certification under the UNE-EN ISO 13485:2018 standard, granted by AENOR.

The expansion is more than paperwork: it determines what the unit can produce, and for whom. Until now, UTADI 3D was licensed to manufacture custom brachytherapy planning molds, a radiotherapy technique that delivers radiation with high precision to specific tumour volumes. 

Under the new scope, the unit can now manufacture other personalised devices for radiotherapy oncology patients, tailored to each patient’s anatomy, which in practice means more precise, reproducible positioning during treatment and less risk of affecting healthy tissue near the tumour.

From pilot service to dual-certified unit

UTADI 3D didn’t arrive here from a standing start. It began operating in March 2019 within the hospital’s Radiation Oncology department. By September 2021, its operational scope had been defined, with dedicated design and manufacturing rooms, and it was folded into the hospital’s Technical and Engineering Service. 

Its first Manufacturing License for Custom Medical Devices by Product Family arrived in June 2023; now, three years later, that certification has been expanded and a design accreditation added alongside it. 

Beyond radiotherapy, the unit manufactures biomodels and molds that accurately reproduce organs and anatomical structures, as well as surgical guides used intraoperatively, all used in preparing complex surgeries. Altogether, this work supports 33 services and units across the hospital, in clinical practice, teaching, and research projects alike, and the unit is one of 25 Spanish units integrated into the Instituto de Salud Carlos III’s Biobank and Biomodel Platform, a national reference network it has belonged to since 2020.

Manufacturing of customized medical devices. Photo via Madrid Public Hospital.

Certified 3D healthcare manufacturing in hospitals

What sets UTADI 3D apart isn’t just the hardware, it’s the regulatory framework behind it. The hospital’s strategy has been to treat 3D printing not as an occasional support tool but as a full-fledged medical device manufacturing activity, subject to the same quality and traceability requirements as any external manufacturer. That’s the gap the dual accreditation closes: it turns the hospital from a mere user of medical devices into a certified manufacturer of its own.

This shift isn’t unique to Spain. In the UK, 3D LifePrints built its business around embedding point-of-care 3D printing hubs inside hospitals, including Alder Hey Children’s Hospital, the Nuffield Orthopaedic Centre, Wrightington Hospital and Leeds General Infirmary, and in 2021 secured ISO 13485:2016 certification for the quality management system behind its patient-specific devices, a step it said would let it standardise its processes and open up new markets. 

More recently, in the US, Indiana University Health opened an upgraded 3D Print Studio this July, ranking among the first hospital-based 3D printing programmes in the country to operate with FDA clearance, developed with Ricoh 3D for Healthcare so that surgeons produce patient-specific anatomical models on-site rather than ordering them from outside service bureaus. 

Model of a pediatric heart. Photo via IU Health.

The pattern is the same across every case: it’s formal accreditation, not just the technology itself, that allows a move from printing prototypes to manufacturing devices used to treat real patients. 

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Featured image shows Manufacturing of customized medical devices. Photo via Madrid Public Hospital.