This feature draws on an AM Medical DAYS panel held in December 2023. It appeared in the March/April 2024 magazine and online on September 26, 2024. Quotations reflect that context; review clarifications distinguish legislation from recommendations and discussion papers.
“Just because you can print it doesn’t mean you can use it.”
This statement from 3D-Side captures an issue highlighted during the Covid-19 pandemic: being able to make a product does not establish its suitability for medical use. This feature distinguishes medical device status, personalized devices and production at the point of care before examining quality and responsibilities.
From surgical instruments to prostheses, market access depends on the product’s intended purpose, risk class and jurisdiction. Additive manufacturing (AM) therefore raises several questions:
- What is a medical device?
- How do personalization and point-of-care manufacturing differ?
- What is the role of a quality management system (QMS)?
- How should responsibilities be allocated?
Defining a medical device
In the European Union, medical device status depends in particular on the intended purpose assigned by the manufacturer. Article 2 of Regulation (EU) 2017/745, the MDR covers purposes such as diagnosis, prevention, monitoring or treatment of disease, where the principal intended action is not pharmacological, immunological or metabolic. In vitro diagnostic devices fall under a different regulation, Regulation (EU) 2017/746. A 3D printed object is therefore not automatically a medical device.
The applicable requirements address safety and performance for the intended use. Classification considers factors such as the nature and duration of body contact, and affects the conformity assessment route.
“As a manufacturer, you are required to know about the legal regulations for your devices, depending on their risk class and on where you are marketing them. Regulations in the EU differ from those in the USA and the regulatory pathway to get a device to market is different. The production technology does not influence your regulatory pathway, so 3D printed devices follow the same pathway as e.g. milled devices,” Erik Boelen, Consultant Medical 3D Printing & ISO 13485 Quality Management explains.
This comparison of regulatory routes does not remove the need to qualify the additive manufacturing process or demonstrate the finished device’s performance.
That being said, as far as the EU market is concerned, Alberto Bardají de Quixano from TÜV SÜD Product Service GmbH outlines that “Medical Devices marketed in the European Union are subject to the Medical Device Regulation 2017/745 (MDR) – this includes devices manufactured using additive manufacturing techniques. Medical Devices are classified based on their intended purpose, duration of use and nature of the contact with the body within other aspects. The Regulation defines different possible assessment routes for Medical Devices based on the classification of the device. Another consideration that may impact the requirements outlined in the Regulation is whether the device is custom-made for a specific patient or mass-produced and available off-the-shelf.”
Under the MDR, a custom-made device is produced following a written prescription from a person authorized under national law, specifying particular design characteristics under that person’s responsibility. It is intended solely for an identified patient’s individual needs. This definition is not the same as dimensional adjustment or the absence of a suitable commercial alternative. The European Commission explains, for example, that adapting mass-produced products does not by itself make them custom-made devices.
A patient-matched device can be fitted to an individual’s anatomy using imaging while remaining within a validated design envelope under the manufacturer’s responsibility. MDCG 2021-3 distinguishes these products from custom-made devices: the regulatory requirements for their category still apply. Neither personalization nor 3D printing alone determines the regulatory status.
According to Boelen, “the MDR only speaks about custom-made medical devices, but it would be better to speak about personalized medical devices, as in the guidance document IMDRF WG/N58. According to the definitions in IMDRF WG/N49; custom-made devices are devices that are uniquely made for the specific anatomy/pathology of one patient as prescribed by his/her surgeon, when there’s no suitable device available on the market.
Patient-matched devices are devices that are also uniquely made for a particular patient, but their design is pre-determined (within a design envelope) and matched to each patient and they are typically produced in a batch process that can be validated and reproduced.
In the TGA document “Personalized medical devices, v5.0”, it is shown nicely that most devices that were previously considered ‘custom-made’ are now considered ‘patient-matched’.”
In this quotation, IMDRF references concern international terminology, while the TGA example concerns Australia. These distinctions help explain personalization but do not replace the EU legal definition of a custom-made device.
Point-of-care manufacturing and the in-house exemption
In this context, point-of-care (PoC) manufacturing describes production at or near the place where care is delivered. It describes location and organization, rather than a separate regulatory category.
In the European Union, the in-house exemption under Article 5(5) of the MDR concerns devices manufactured and used within a health institution that meets all the specified conditions. These include an appropriate quality management system, no transfer to another legal entity and justification that the target patients’ specific needs cannot be met at an appropriate performance level by an equivalent marketed device. Documentation, a public declaration and review of clinical experience are also required. The relevant Annex I requirements still apply; the exemption does not cover manufacture on an industrial scale. MDCG 2023-1 explains these conditions.
Discussing devices that satisfy these in-house conditions, the TÜV SÜD expert explains:
“These devices are subject to Article 5.5 in the Regulation and must comply with the General Safety and Performance Requirements outlined in Annex I. They must also be manufactured ‘under an appropriate Quality Management System’. So, it is an obligation that these devices are produced under an implemented QMS. The best way to ensure adequacy of the QMS is compliance with ISO 13485. At TÜV SÜD we offer auditing of the QMS to ISO 13485 with a specific focus on 3D printing processes according to ISO/ASTM 52900. This specific expertise in AM manufacturing may benefit any 3D printed device manufacturer and also point of care producers which may want to ensure the effectiveness of their QMS and ultimately the safety of their products” TÜV SÜD Product Service GmbH expert points out.
Article 5(5) requires an appropriate QMS; it does not, by itself, require ISO 13485 certification. The reference to that standard above is the interviewee’s recommendation. The location of production does not remove the need to check every condition of the exemption.
United States: three FDA discussion scenarios
The FDA’s December 2021 discussion paper describes three possible arrangements for point-of-care manufacturing. The agency expressly states that this is not guidance: it invited comments to inform future policy. The table summarizes these historical scenarios, rather than presenting them as authorizations.
| Proposed arrangement | Principle described |
|---|---|
| 1. The facility uses a medical device production system (MDPS) | The manufacturer provides the system; the facility uses it within its intended use and instructions. |
| 2. A manufacturer operates at or near the care facility | The facility receives devices from a manufacturer producing them on site or nearby. |
| 3. The facility takes on the manufacturer’s functions | The facility chooses to perform the manufacturer’s activities and meet the corresponding regulatory obligations. |
Source: FDA, 3D Printing Medical Devices at the Point of Care, December 2021, pages 8–9. This table replaces the five-scenario outline reproduced in the original feature.
Each arrangement requires clarity about who designs, manufactures, controls and uses the device. The quality system must support those activities and their regulatory requirements.
The role of the quality management system
A quality management system (QMS) organizes responsibilities, processes and evidence that they are controlled. For medical devices, this goes beyond customer satisfaction: it must also address applicable regulatory requirements, risk management, documentation, traceability and corrective actions.
That’s the reason why Boelen says QMS has an image of being boring and bureaucratic, but that mainly has to do with the “rigidity” of the system. “A paper-based QMS makes document review, approval, and versioning very cumbersome, but in digital systems, this is quite straightforward. I also believe that if you have a separate, dedicated system for your QMS, most employees hardly ever need to use that (besides the Quality Manager), which increases the threshold to do so. That’s why I advocate for the use of a company wiki that includes the QMS; since such a wiki is used regularly to build a knowledge base and record shared meeting notes, the QMS is much more accessible since it is embedded in daily work practices,” he adds.
The wiki is a suggested way to organize documentation. The tool alone does not demonstrate control of versions and approvals, or compliance of the quality system.
During the 2023–2024 interview, in the words of Bardají de Quixano, it’s important to keep in mind here that “we are currently transitioning from the old European Directive to the MDR. The MDR ultimately aims to ensure safety and performance of the devices used in patients. This is positive even if ensuring and proving compliance may pose some challenges. As we transition to the new Regulation, we also find room for pragmatism and practicality in the application of its requirements.”
On a more practical note, Boelen adds that the type of tests required to qualify medical 3D printed products depends on the intended use of that device. For example, if the device is load-bearing, mechanical tests will be inevitable. Biocompatibility tests on the final device should be considered as the 3D printing process changes the material during printing and the resulting material may not be as biocompatible as the starting material.
Furthermore, Bardají de Quixano reminds that 3D-printed Medical Devices are subject to the same requirements as devices manufactured using traditional techniques. These requirements are defined in the General Safety and Performance Requirements in Annex I of the Regulation and include aspects like Biological Safety, Cleanliness, Fracture Resistance, Wear Resistance and Fatigue Resistance among others.
However, “there is a series of ISO and ASTM standards specific to Medical Devices that define state-of-the-art test methods which are considered acceptable to prove compliance with these requirements. The acceptance criteria are the same for AM devices as for any other device as they are defined by the intended purpose and expected performance. Special attention must be paid in the case of 3D printed devices to aspects like variability in the test results and failure mode analysis due to the nature of the manufacturing process.
Validation and control of the 3D printing process and post-processing is pivotal to obtain repeatable test results. ISO/ASTM 52900 and the rest of ISO/ASTM 529xx series constitutes a useful tool to set-up, validate and control 3D printing processes. There are also other ASTM standards which are helpful for specific 3D printing techniques and associated material specifications and test methods. These standards are of general application but valid for Medical Devices. ASTM F3335:2020 provides guidance for assessing the removal of powder debris in SLS Medical Devices,” he adds.
Two references in this quotation need clarification: ISO/ASTM 52900:2021 establishes AM fundamentals and vocabulary; it is not a validation procedure on its own. ASTM F3335-20 concerns assessment of residue removal from devices made by powder bed fusion, beyond SLS alone. The guide does not prescribe universal acceptance limits for those residues.
Allocating responsibilities
The prescriber and manufacturer have different roles. For a custom-made device, responsibility for prescribed design characteristics does not remove the manufacturer’s obligations, including those in Annex XIII of the MDR. Similarly, locating a printer in a hospital does not assign all responsibility to that hospital: the actual arrangement, each entity’s activities, the device’s status and national rules need to be considered. The in-house exemption also retains obligations for the health institution.
Preparing for market access
Before selecting a market access route, establish the intended purpose, classification, target jurisdiction and each party’s responsibilities. Professional recommendations can support good practice, but do not replace regulatory requirements or evidence of safety and performance for the device concerned.
Editor’s notes
I had the pleasure of hosting a panel discussion on this topic at AM Medical DAYS 2023 in Berlin, a medical 3D printing event held in Berlin in December 2023 and organized by IPM AG. The panel gathered Alberto Bardají de Quixano, Orthopaedic Implants Product Specialist, TÜV SÜD Product Service GmbH; Bernhard Pultar, CEO & Co-Founder, POC APP AG; as well as Dr. Erik Boelen, Consultant Medical 3D Printing & ISO 13485 Quality Management, Qase3D. The panel received such positive feedback that we decided to share in this issue key insights medical device manufacturers should keep in mind while walking the road of medical 3D printed devices. Given the length requirements of this article, we only shared Alberto Bardají de Quixano and Erik Boelen’s insights.
This feature was first published in the March – April 2024 edition of 3D ADEPT Mag.
Review note: the custom-made definition, in-house conditions and allocation of responsibilities have been clarified against official sources. The US table now presents the three scenarios in the 2021 discussion paper. Interview statements remain in their original time context and are not an exhaustive account of current requirements.
THE 3D ADEPT WEEKLY NEWSLETTER
The industry moves fast. Stay ahead.
Every week, the latest additive manufacturing news, in-depth features and real-world applications, straight to your inbox. Plus, be the first to know when a new issue of 3D ADEPT Mag is out.
Free · One email a week · Unsubscribe anytime
Clicking loads our email provider’s sign-up form, including its analytics and Google’s anti-bot protection. You’re only subscribed if you complete the sign-up. Read our privacy policy.