Madrid Hospital Earns Certification to Manufacture Its Own 3D Printed Devices

A public hospital that makes its own devices

The Advanced Technologies in Design and 3D Printing Unit, known as 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 a dual certification. One covers design, the other covers manufacturing, and both apply to each family of custom medical devices the unit builds.

The recognition came from AENOR under the UNE-EN ISO 13485:2018 standard, after the hospital expanded both its manufacturing license and the scope of its certification. In plain terms, the unit can now do more than print prototypes. It can legally manufacture devices that go into real patients.

What changed on the shop floor

Until now, UTADI 3D was licensed to make custom brachytherapy planning molds. That is a radiotherapy technique that aims radiation at a tumour with tight precision. Under the new scope, the unit can build other personalised devices for radiotherapy oncology patients, shaped to each person's anatomy.

The practical payoff is better positioning during treatment and less chance of harming healthy tissue near the tumour. For a hospital, that is the difference between a nice to have tool and a regulated part of care.

Seven years of quiet buildup

This did not appear overnight. UTADI 3D started inside the hospital's Radiation Oncology department in March 2019. By September 2021 it had dedicated design and manufacturing rooms and 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. Three years later, that license expanded and a design accreditation was added alongside it.

Beyond radiotherapy, the unit prints biomodels and molds that reproduce organs and anatomical structures, plus surgical guides used during operations. The work backs 33 services and units across the hospital in clinical care, teaching, and research. The unit is also one of 25 Spanish members of the Instituto de Salud Carlos III Biobank and Biomodel Platform, a national reference network it joined in 2020.

The bigger shift in hospital 3D printing

Spain is not alone in this move. In the UK, 3D LifePrints has run point of care printing hubs inside hospitals such as Alder Hey Children's Hospital and secured ISO 13485 certification in 2021. In the US, Indiana University Health opened an upgraded 3D Print Studio this July that operates with FDA clearance, built with Ricoh 3D for Healthcare, so surgeons can print patient specific models on site instead of ordering them from outside bureaus.

The pattern is the same everywhere. The technology was never the hard part. Formal accreditation is what lets a hospital move from printing models to manufacturing devices that treat people. Madrid just became the first public example of that in Spain.