3D Printing Revolution in the Medical Device Industry

In the last decade, 3D printing has had a profound impact on the medical device sector. When the COVID-19 pandemic hit, this technology was lauded for its ability to adapt new designs and the speed with which it could produce the necessary commodities. Medical 3D-printed gadgets have a bright future, and we will go through the latest advances and how regulatory bodies across the world are keeping up with this development.

Basics of 3D Printing

Medical 3D printing has shown remarkable promise in the last several years, and the technology's advancement is very powerful. Another name for this cutting-edge approach to production is "additive manufacturing”. Instead of slicing away pieces of a larger piece, a printing technique deposits the raw material for the creation layer by layer.

In the advent of 3D printing development, point-of-care (PoC) 3D printing manufacturing has grown massively. Instead of a medical device manufacturer producing the medical device, a hospital or in a centralized facility owned by the health care organization prints the medical device on demand using digital data like CAD files, actual MRI and CT images from the patient and/or in combination with other imaging results.

By 2027, this segment is expected to achieve a 22.5% growth rate from an estimated base value of USD 1.7 billion in 2020. This is attributed to the advancements in the 3D printing technology, growing number and variety of clinical applications, demand for customized implants, and intensification of R&D investments from both manufacturers and healthcare institutions.

Top Applications of 3D Printing for Medical Devices

  1. 1.  Surgical Planning and Customized Surgery


3D printed models of organs and tumors have made it easier for surgeons to think of problems before they happen, come up with better treatment options, and reduce the risk of the surgery. Since the model can be constructed from the actual ultrasound, MRI or CT scan/s of the patient, the anatomy and pathology are visualized realistically and improves the chances of a successful surgery.

This, ultimately, results in less time in the OR, faster recovery of the patient and overall lower costs for the healthcare facility. In addition, medical students learning experience and training is also improved.

  1. 2.  Design and Manufacture of medical devices and surgical instruments

Because surgical equipment is less complicated and intrusive than human organs, 3D printing has been used to create forceps, medical clamps, retractors, hemostats, needle drivers, and knife handles. Less regulatory constraints are also associated with these products. As a result, this has already been used much more widely in the healthcare business.

Because designs may be updated and manufactured rapidly with 3D printing, building a prototype can be done, tested, and modified quickly. The surgeon’s feedback can easily be incorporated into the next modification.

Tessa's Weekly Picks - 3D Printed Surgical Tools - LEO Lane | 3d printing,  Prints, Clever design

  1. 3.  Moulds, Prostheses And Customizable Implants

Five pieces of medical equipment that can be made with 3D printing

Customized bionic prosthetics can be very expensive. Despite the fact that conventional prosthetic sizes are commonly accessible, only a few companies produce them.  This significantly impacts children who are constantly outgrowing their prostheses and necessitate specific replacement components since only a few manufacturers produce them. To create prosthetics at a reduced cost and with fewer time limitations, 3D printing may be used by prosthetic designers all around the world. Compared to conventional manufacturing, the finished product also has higher performance, greater anatomic compatibility, and a longer lifespan.

Because 3D printers can generate complicated pieces, they provide physicians with more freedom to experiment with treatment alternatives that they would not have been able to perform with regular parts and materials.

  1. 4.  Digital Dentistry

Dental prosthesis fabrication often involves several manual processes in order to guarantee that the finished result is tailored to the specific measurements of each patient's oral cavity. It has become easier and more cost-effective for dentists to produce the same product using 3D printing technology. Using this procedure, an intraoral scan can be used instead of the traditional manual impressions, castings, and grinding steps. It is possible to manufacture clear aligners straight from scans, for example.

3D Printer Resins for Dental Devices May Pose Risks for Reproductive Health  - Dentistry Today

5.  3D Printing Biomaterials

3D printing in the medical field

Tissue engineers were able to 3D print blood arteries, bones, heart valves, human ears and noses, synthetic skin, and other synthetic organs using genuine human tissue samples or when combined with other materials or tissue samples. Aside from being used directly to implant, patch, or replace the original tissue or organ, 3D printed tissues and organs may also be utilized as models for toxicity testing of novel medications.

Current Regulatory Landscape for 3D Printed Medical Devices

Across the globe, different countries are drafting and amending their regulations to properly encompass 3D printed medical devices.

European Union

In the EU, 3D printers must comply with the applicable safety and essential health requirements under Machinery Directive 2006/42/EC. Prior to marketing, the device must possess a CE mark and technical file must be submitted. In addition, the Electromagnetic Compatibility Directive 2014/30/EC, and EU legislation on chemicals, WEEE 2012/19/EU, RoHS II 2011/65/EU Directive and Directive (EU) 2017/2102, and REACH 1907/2006/EU may also be applicable to 3D printers.

For 3D-printed medical devices, on the other hand, it is much more complex. The European Medical Device Regulation (MDR) 2017/745 is the main guideline for these products. The Medical Device Coordination Group (MDCG) has been refining previously ambiguous definition of terms, such as custom-made devices (CMDs). The term applies to those that are produced at the request and written prescription of a licensed medical practitioner with specific design characteristics or construction intended for the exclusive use of a particular patient’s unique needs and medical condition.

CMDs are not required to have a pre-market notification. However, the line begins to blur because of the following are not considered as CMDs:

(a) Devices that are mass-produced which need to be adapted to meet the specific requirements of any professional user, also called adaptable medical devices.

(b) Devices that are mass-produced by means of industrial manufacturing processes, potentially made in accordance with the written prescriptions of an authorised person.

Before, it was unclear whether or not 3D printing is considered as an industrial manufacturing process. With MDCG 2021-3, however, it was clarified that any technology, including 3D printing can be used to manufacture CMDs. It ultimately boils down to whether or not the device in question is mass-produced or not. Non-CMDs will have to go through the routine medical device risk-based registration routes.


The US FDA only regulates medical products manufactured using 3D-printing and keeps the 3D printers unregulated. The regulatory route is decided according to the type of product, it intended use and accompanying patient risk. Only medical devices are handled by the Center for Devices and Radiological Health (CDRH). Drugs and biologics are handled by different centers.

Custom medical devices are exempted from premarket approval submissions given that the number of devices produced annually is below 5 and it is designed to treat a distinct condition not solvable with domestically available devices. US FDA also maintained the emergency use authorization route for 3D-printed ventilators.

Until last 08 February 2022, US FDA requested the stakeholders to comment on their discussion paper on PoC 3D printing of medical devices. The current updates tackled the following:

  1. 1. FDA must assure the safety and effectiveness of 3D printed devices at the PoC (May require registration in the future)
  2. 2. Assuring appropriate control of devices 3D printed at the PoC
  3. 3. The need to clarify entities responsible for the device life cycles
  4. 4. 3D printing of devices at the PoC should possess adequate knowledge and expertise training to deal with issues.


In 2021, the Therapeutic Goods Administration (TGA) issued a new regulation which tightened the rules involving 3D printed medical devices. Several kinds of 3D-printed customised medical equipment, including batch manufactured devices, organ models, and bioprinted devices, are no longer included in the current exclusions and are required to be included in the ARTG based on the regulatory framework. Manufacturers will be required to have a certification as that they are required to do for other regular medical device

Despite the fact that other 3D-printed custom-made devices will continue to be excluded from the regulation, the regulatory requirements for these devices will be tightened. However, an ARTG inclusion is required for healthcare providers that are presently using 3D printing technology to produce medical devices that have lost their exemptions, including adaptable medical devices, patient-matched medical devices and medical device production systems (MDPS). This is true regardless of whether these providers outsource the production or utilize a third-party-supplied medical device processing system.

Asia Pacific

The Asian market is anticipated to have the greatest 3D printing market growth despite the fact that the largest share is still in North America. Different countries are gearing up both in technology and policy to prepare for this. A common strategy is the collaboration between research institutes and manufacturers with the local government.

  • China – the China National Institutes for Food and Drug Control (NIFDC) under the NMPA has been working hard since 2014 to set up industry standards for 3D printed medical devices. The Chinese government also crafted innovation goals starting in 2015 with the National 3D Printing Industry Development Promotion Plan. In October 2021, NIFDC has already set the medical additive manufacturing standards working group. This standard system looks at raw materials, process verification methods, equipment, data transmission, and risk management. It also looks at the whole process chain of additive manufacturing technology.

As early as 2018, the Chinese government collaborated with foreign companies such as the partnership between Shanghai Children’s Medical center and Materialise, a Belgian 3D Printing company. This has enabled children with heart diseases to receive free medical care instead of spending around US$16,000.

Since 2019, NMPA has released several technical reviewing guidance for 3-D printing devices as follows,

1. Regulations on the Supervision and Administration of Customized Medical Devices (Cirular No. 2019-53)

2. Guiding principles for the technical review of the registration of passively implanted bone, joint and oral hard tissue personalized additively manufactured medical devices (Circular No. 2019-70)

3. Guidelines for Technical Review of 3D Printed Acetabular Cup Product Registration (Circular 2020-36 Attachment 2)

4. Guidelines for technical review of 3D printed artificial vertebral body registration (Circular 2020-36 Attachment 3)

5. Guidelines for Registration Review of 3D Printed Patient-Matched Mandibular Implants (Circular No. 2020-62 Attachment 5)

  • Japan- In 2015, Japan's New Energy and Industrial Technology Development Organization in Kanagawa announced that it was investing $30 million in the development of 3D printing mechanisms that could be used to make new human tissue. This was done to propel the growth of regenerative medicine even further. The Central Social Insurance Medical Council said the Japanese medical system would pay for the cost of 3D-printed organ models in 2016. As a result of this policy, patients can get more advanced medical care at a lower cost. It also allows 3-D printing companies in Japan to reach a larger group of patients in need of customized medical devices and to help with new technology.

  • Korea- With the help of foreign institutions and medtech personnel, Korea expressed its plan in 2020 to lead worldwide standards of medical 3D printing. This proposal will establish a standard for generating patient-specific 3D printed medical equipment if accepted. State-of the-art 3D printing, robotics, and nanotechnology-based medical equipment are being evaluated on an expedited process by Korea's Ministry of Food and Drug Safety (MFDS). Companies with superior 3D items will be able to market faster than their competitors

  • Singapore-  HSA has categorized 3D-printed medical devices as either mass-produced or custom-made. Mass-produced medical devices are standard size devices which can be adapted to an individual or also referred to as patient-matched medical device.  Whereas custom-made medical devices definition follows that of the EU or IMDRF.

Only class B, C and D patient-matched medical devices are required to be registered by 01 August 2022 for companies to continue to supply their products locally. The current requirements for the class B-D devices apply to this 3D-printed devices.


What medical devices are 3D printed?

Surgical equipment, organoids, orthopedic implants, dental implants such as crowns, and external prosthesis may now be 3D printed.

What can 3D printing be used for in healthcare?

Modern innovations in 3D printing have resulted in more lightweight, sturdier, and safer goods, as well as shorter lead times and cheaper prices. Organoids, orthopedic and dental prosthetics, surgical models, and customized surgical tools are well-known examples of the medical applications of 3D printing.

Can you 3D print PPE?

It is possible to use a 3D printer to produce PPEs but 3D-printed PPEs are unlikely to offer the same barrier and filtration efficiency when compared to regulatory body approved N95 respirators and surgical masks.

Are there laws about what can and cannot be 3D printed?

Generally, it is prohibited to 3D print patented products, bombs, and assault weapons.




  1. 1. Healthcare 3D Printing Market Report by Global Market Insights
  2. 2. Top 8 healthcare uses for 3D printing
  3. 3. Medical Device Coordination Group Document MDCG 2021-3
  4. 4. What Is Medical 3D Printing—and How Is it Regulated?
  5. 5. Medical 3-D Printing Update in Asia