A few weeks ago, we reported that Singapore’s Ministry of Health had added Osteopore Limited’s craniomaxillofacial and oculoplastic implants to its Implant Subsidy List (ISL). This milestone highlights a key challenge in the adoption of patient-specific care powered by additive manufacturing: cost. Despite its advantages, 3D-printed medical solutions often remain more expensive for patients than standard treatments. The Singaporean decision underscores the critical role of reimbursement policies in making 3D printing more accessible across hospitals.
This development led us to examine the landscape in Europe. To gain deeper insights, we spoke with María Gloria Álvarez Caballero, Head of the Equipment Department & Quality Manager at SIMIM3D in Spain, and Dr. Dr. Neha Sharma, Deputy Director of the 3D Print Lab at University Hospital Basel and Chief Medical Officer of POC APP AG in Switzerland.
This dossier aims to discuss initiatives and financial support already available for patients across Europe – when applicable. The goal remains to encourage healthcare providers to further rely on 3D printed medical devices and patients to be more confident when benefiting from advanced healthcare solutions.
In general, all systems in the European Union employ a third party to pay or to insure health expenses for beneficiaries for the times when they are patients. The path to reimbursement becomes difficult when digital health solutions are leveraged. More specifically, the path to reimbursement we aim to explore is the one of 3D-printed medical devices, which may be more accurately categorized under “medical additive manufacturing” or “digital manufacturing in healthcare.”
Understanding why comes down to answering a one-million-dollar question: Who will pay?
In addition to payers, four groups of individuals or organizations could potentially pay for digital health solutions: patients, healthcare providers, employers, and industry partners.
In a recent report, global management & consulting firm McKinsey & Company explains that patients who can afford it can pay for a digital health solution but since public healthcare systems or healthcare payers cover the cost of medical treatment in most European countries, individuals are generally reluctant to pay for extras. The reality is that there are also patients who cannot afford to pay for digital health solutions that are sometimes vital to their health.
Healthcare providers can pay directly for a solution, but they too will be cautious. They might be more willing to pay if the solution delivered operational improvements, such as faster and more accurate diagnoses.
Industry partners refer to companies such as medical device manufacturers or pharmaceutical companies that might pay for a solution if it gives them access to data or complements their own products or therapies.
As for employers, they can pay for a digital health solution either to improve their employee value proposition or to reduce the level of sick leave.
This broader context shifts the debate toward how we should categorize AM.
Can AM be considered a digital health solution?
Digital health typically refers to technologies that leverage software, AI, big data, and connectivity to enhance healthcare delivery or patient care. Even though it operates within a digital framework, AM alone cannot be considered a digital health solution.
While AM is not a digital health solution in the regulatory sense, it plays a key enabling role in the digital transformation of healthcare, particularly through personalized treatments, surgical planning, and device production. As such, it intersects with digital health efforts but follows distinct clinical and reimbursement pathways.
The path to reimbursement for 3D printed implants: state of the market and barriers
First and foremost, the Singaporean case reveals that the Implant Subsidy List includes subsidized implants and accessories used in public healthcare institutions. Eligible patients receive subsidies based on their means-test status. It’s important to note that although it categorizes implants into different categories, it does not particularly distinguish the manufacturing processes of these implants.
Speaking of the situation in Europe, Dr. Neha Sharma explains: “While 3D-printed implants are gradually gaining recognition in Europe, reimbursement frameworks for patient-specific medical devices (e.g. anatomical models, surgical guides, implants) in general remain inconsistent. In many cases, existing pathways primarily apply to standard devices sourced from MedTech companies, and it is not always clear how or whether these pathways extend to patient-specific solutions. In Switzerland, reimbursement decisions are typically made on a case-by-case basis, often tied to Diagnosis-Related Groups (DRGs). This means that coverage is determined by how a procedure and implant are categorized within the health insurance system rather than by the manufacturing method itself.
However, some hospitals and research institutions receive public funding for pilot projects and clinical studies related to 3D-printed implants. Even in such cases, in-house manufactured implants—whether intended for clinical studies or final use—are regulated under the MDR and corresponding national laws. At University Hospital Basel, our team has developed an MDR-compliant workflow for in-hospital 3D printing as part of ongoing clinical and research efforts. While this demonstrates feasibility within existing regulatory structures, systematic reimbursement remains a challenge across Europe, and clearer funding mechanisms will be necessary to drive broader adoption.”
“As far as I am aware, there are no specific policies or financial incentives for 3D-printed implants. Reimbursement can be granted for certain 3D-printed implants in some countries when they are justified as medically necessary and when their use is supported by sufficient clinical evidence. It is really not so different from other reimbursement grants for clinical indications or medical devices non-related to 3D printing. The reimbursement process is more streamlined in certain specialties, such as craniomaxillofacial and orthopedic implants. On the other hand, some hospital entities have access to financial support to develop 3D-printed implants based on evidence of improved patient outcomes. This financing can be external (i.e. from research studies) or assigned from the internal budget,” María Gloria Álvarez Caballero completes.
We have learned over the years that patient care remains expensive with AM due to customization as well as material and certification costs. Limited reimbursement models bring a certain complexity to the table to the extent that many insurance systems are built for standardized medical devices rather than bespoke, digitally designed, 3D-printed solutions. For Caballero, 3D printing being considered as a “novel technology” , reimbursement would likely depend on robust clinical evidence showing the safety, effectiveness, and cost-efficiency of 3D-printed implants.
In addition to cost-effective evaluations, Dr. Sharma mentions regulatory complexity and healthcare budget constraints as other barriers preventing broader reimbursements of 3D printed implants. “All medical devices have to comply with the general safety and performance requirements of the Medical Device Regulation (MDR), and although in-hospital 3D printing is emerging as a viable production method, reimbursement structures have not fully adapted. Another key hurdle is the need for robust, long-term clinical and economic evidence to demonstrate the value of 3D-printed implants compared to conventional solutions. Many insurers require such data before approving reimbursement for newer technologies.
Budget limitations also play a role, as public healthcare systems tend to prioritize established treatments over newer or less familiar approaches. Additionally, hospitals building internal workflows for implant production often face regulatory and legal complexities. In these cases, collaborations with specialized external partners can provide support in navigating MDR requirements and implementing effective strategies”, she notes.
The good students of Europe
From a cost standpoint, since reimbursement pathways for digital health solutions are evolving at different paces across Europe, our research reveals that Germany, Sweden, and the United Kingdom are relatively mature markets where governments are promoting the digital transformation of healthcare with AM as one of the enablers and have standardized reimbursement pathways. In practice, this does not mean that they are all leading the way when it comes to adopting 3D printed implants in public hospitals.
“From the hospital’s point of view, I am personally excited about the developments Switzerland has achieved in the past years. This is clear proof that in-house 3D-printed implants can perfectly meet the requirements of international standards for medical devices,” María Gloria Álvarez Caballero enthuses.
In addition to Switzerland, Dr. Sharma gives the spotlight to Germany, the Netherlands, Austria and Belgium, although each follows a distinct approach.
Across Europe, healthcare systems are adopting various approaches to integrating 3D-printed implants into clinical practice. Based on publicly available information and collaborative insights, several models are emerging that reflect the unique strengths of each healthcare context. In Germany, for instance, industry partnerships play a key role, with private companies often collaborating closely with hospitals to support in-house production. The Netherlands is expanding accessibility to 3D-printed implants within public hospitals, largely through collaborations with external manufacturers. Belgium makes significant contributions through its robust industrial base in additive manufacturing, supporting supply chains for 3D-printed patient-specific solutions. In Switzerland, hospitals are exploring in-house production models. At University Hospital Basel, for example, our team has worked on aligning point-of-care 3D printing workflows with MDR requirements. This experience highlights how hospital-led manufacturing can be integrated into existing regulatory structures with the right infrastructure and support. Additionally, this approach was successfully transferred to the University Hospital Salzburg in Austria, which proves that the concept is viable across international borders. This approach of sharing knowledge between hospitals tremendously reduces costs, fosters close collaboration, and promotes mutual learning.
These examples illustrate that there is no one-size-fits-all model. Each country’s approach is shaped by its healthcare system, regulatory framework, and institutional capacity—demonstrating the richness of strategies being developed to advance personalized care through 3D printing. As these models continue to evolve, they reflect the dynamic interplay between innovation, regulation, and healthcare financing in each setting.” she points out.
Public-private partnerships that contribute to the growth of 3D-printed medical implants in Europe
For Caballero, “funding is needed to test new 3D-printed implants and confirm a sufficient level of clinical evidence.” – That’s a fact. At a pan-European level, EU-funded projects gather partners from universities, research centers, SMEs, multinational corporations and hospitals to advance the use of viable 3D printed implants.
Ceramic 3D printing company Lithoz recently reminded us that the INKplant project is one of them. With 19 partners across 7 countries, the consortium aims to combine different biomaterials, high-resolution AM technologies, advanced simulation and biological evaluation, to bring a new solution for the fabrication of biomimetic implants for tissue regeneration.
The project led by Profactor GmbH recently saw the implantation of a 3D printed ceramic subperiosteal jaw implant in a patient. Described as a first, the team relied on Lithoz LCM technology to manufacture the implant.
While “upfront costs for implementing additive technologies to manufacture 3D-printed implants can be really expensive, infrastructure sustainability will depend on the size of the hospital entity and its clinical workload. This is the reason why, depending on the situation, access to cutting-edge technology and expertise from private entities is crucial to offer high-quality medical treatments. On the other hand, private entities have also proved to offer efficient regulatory support to help navigate the regulatory landscape. This is especially important in class III medical devices developed in a point-of-care,” Caballero outlines.
Dr. Sharma provides substantial information on options available to navigate this regulatory landscape:
“Public-private partnerships (PPPs) play a critical role in accelerating regulatory adaptation, technological innovation, and clinical integration. Hospitals often collaborate with external organizations to access regulatory and technical expertise that support the safe implementation of 3D-printed medical devices.
For example, at POC APP AG, our multidisciplinary team—including regulatory specialists, our CEO Mr. Bernhard Pultar, and our CTO Mr. Daniel Seiler—supports hospitals in developing MDR-compliant workflows for point-of-care manufacturing. These partnerships enable healthcare institutions to develop in-house capacity for personalized implant production, ensuring safety and compliance. They also illustrate how clinical evaluation, technological advancement, and regulatory strategy can converge to establish hospital-led 3D printing ecosystems.
Although the European Commission has shown interest in accelerating approvals for technologies with high potential for public health impact, there are limited fast-track regulatory programs for innovative implant technologies in Europe.
Most industrially manufactured medical devices must undergo a conformity assessment under the EU Medical Device Regulation (MDR). Custom-made devices, including 3D-printed implants tailored for individual patients, follow a distinct regulatory pathway and are exempt from CE marking, but must still meet the General Safety and Performance Requirements (GSPRs) set out by the MDR. Unlike pharmaceuticals, there is no widely recognized expedited pathway for medical implants, which means that regulatory approval still requires extensive clinical evaluation.
Some countries have initiatives that support the early adoption of medical technologies, though these do not replace formal regulatory requirements. For example, Germany’s Innovation Fund promotes pilot clinical studies, and the UK’s Accelerated Access Collaborative facilitates the integration of selected technologies into the health system.
In Switzerland, MDR compliance is addressed through the National Medical Device Ordinance (MedDO). While there is no official fast-track process for 3D-printed implants, some hospitals, including ours, have explored how in-house production workflows can align with regulatory standards. At University Hospital Basel, we developed an MDR-compliant process as part of a clinical research initiative, demonstrating that point-of-care manufacturing can be integrated into a hospital setting under existing frameworks.
Looking ahead, regulatory adaptations that account for the specific needs of point-of-care manufacturing could further support adoption while upholding safety and quality standards” Dr. Sharma states.
Concluding notes
At first glance, one might assume reimbursement for 3D-printed implants is unclear due to their connection to digital workflows. However, the primary challenge lies in their classification as high-risk Class III medical devices, which are rightly subject to rigorous regulatory oversight. Unlike lower-risk digital health applications—such as approved software—these implants follow a more complex clinical and reimbursement pathway, which naturally slows broader adoption despite their potential benefits for personalized patient care.
That said, “the adoption of 3D-printed implants in public healthcare is advancing, but its future depends on regulatory adaptation, clinical validation, and reimbursement frameworks. Drawing on our experience in clinical translation for point-of-care 3D printing, we anticipate broader adoption in the coming years as regulatory frameworks continue to evolve and align with emerging hospital-based models. The next step is to develop sustainable reimbursement models and establish dedicated regulatory pathways that address the specific needs of hospital-based 3D printing and patient-specific implants,” Dr. Sharma said.
“Given the potential for personalized, patient-specific implants to improve clinical outcomes, collaboration between healthcare providers, researchers, economic operators, and policymakers, remains essential to overcome the challenges related to standardization, regulatory approval, and reimbursement. If successful, more countries will develop specific reimbursement pathways for 3D-printed implants in the coming years, further consolidating clinical evidence,” Álvarez Caballero concludes.
Featured image: 3D ADEPT Media | This dossier has first been published in the March/April edition of 3D ADEPT Mag.
