The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical devices manufactured by using the 3D-printing technology. The document is intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by medical device manufacturers to ensure compliance with the respective requirements. The authority additionally mentions that the document is not intended to introduce new rules and requirements.
According to the definition provided in the guidance, 3D printing, or Additive Manufacturing (AM) is a process of building an object layer by layer, based on a digital model. It is the opposite of conventional subtractive manufacturing. It is further stated that such a technology is mostly used for manufacturing such products as:
- Non-invasive prosthetics;
- Dental devices;
- Surgical tools and guides;
- Implantable devices.
The most used technologies are powder bed fusion, stereolithography, fused filament fabrication, and liquid-based extrusion. The main advantage of AM technology is the possibility to change the design of the device significantly without the need to change the manufacturing equipment.
At the same time, medical devices manufactured by the device of 3D printing have the same regulatory status as the ones manufactured ordinarily. For instance, they should also comply with the applicable Essential Principles of Safety and Performance described in detail in the appropriate guidance issued by the HSA. The particular rules and requirements to be applied about such devices depend on their intended use, indications for use, as well as risks associated thereto.
It is also important to mention that in vitro diagnostic medical devices are falling outside the scope of the present guidance.
According to the guidance, 3D-printed medical devices could be subject to regulation as either “mass-produced” or “custom-made” medical devices. It is further explained that mass-produced medical devices could be divided into three main categories: standard-sized products, adaptable devices, and patient-matched devices. At the same time, custom-made devices are manufactured upon a specific request of a healthcare professional, hence, should be used only for a specific patient. Such an approach is usually applied in situations when existing mass-produced devices do not meet specific needs. As it is mentioned by the HSA, the use of AM technology allows mass-producing patient-matched medical devices, which are manufactured based on a design envelope – a description of the parameters the device requested should meet to be suitable for use for the intended purpose. The authority also states that in the case of patient-matched medical devices, their safety and performance are subject to validation in terms of a batch of several devices manufactured by the appropriate specifications.
In the case of custom-made medical devices, the most important concept in the design characteristics or construction, which is defined as unique design specifications, including mechanical performance necessary to produce custom-made devices and which are based on an individual’s specific anatomo-physiological features and/or pathological condition.
The guidance further provides the specific criteria to be considered when determining whether the 3D-printed product in question is a custom-made device. In particular, according to the document, when making such a determination it is necessary to assess whether the medical device in question is:
- Intended to be used only by a specific patient;
- Adapted from another device, which is mass-produced;
- Created under the design envelope;
- Manufactured upon written request of a healthcare professional, indicating the particular design characteristics or construction.
It is important to mention that mass-produced medical devices are subject to registration under the appropriate requirements. Should the device in question be manufactured by a healthcare facility for its internal needs, an additional consultation with the regulating authority is required.
Moreover, a standard risk-based classification applies to 3D-printed medical devices as well. According to this classification, all medical devices could be divided into four classes from A to D respectively depending on their nature and functions. To be allowed for marketing and use in the country, mass-produced 3D-printed devices should be duly registered by the requirements applicable for the particular class.
The same approach applies to change control. Depending on the changes to a medical device already placed on the market, and the way such changes impact its safety and performance, the manufacturer could be obliged to notify the authority and conduct additional actions.
The scope of information regarding the device its manufacturer shall submit to the HSA depends on its intended use, class under the risk-based classification system, and also on the pathway followed during the registration.
The guidance further describes in detail the most important aspects to be considered about 3D-printed medical devices. These aspects include, inter alia, the following ones:
- Device Validation Consideration. The HSA recommends evaluating the biocompatibility of the product following the applicable international standard, namely, ISO 10993-1. The assessment should be based on a final device. Alternatively, the manufacturer will have to provide additional information demonstrating that the materials used will not expose patients to additional risks.
- Labeling and expiration date. In the case of patient-matched medical devices, the following rules should be fulfilled: (a) labeling should contain the details sufficient to identify the particular patient, (b) compatibility of the device should be additionally checked before applying the device, (c) the expiration date of the device should be calculated from the patient imaging date since the applicability of the device depends significantly on the current state of patient’s health and anatomy, hence, the standard approach could not be applied.
- Manufacturing Consideration. The manufacturer shall provide sufficient information about the particular manufacturing technology applied. Furthermore, according to the guidance, all manufacturing activities for the medical device including the additive manufacturing and post-manufacturing processes should be performed within an ISO 13485-compliant quality management system.
In summary, the present HSA guidance highlights the most important aspects to be considered about medical devices manufactured by the device of 3D printing (additive manufacturing) technology. The document provides additional clarifications regarding the regulatory status of such products and describes the requirements 3D-printed medical devices are subject to.
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