HSA issued a draft guideline concerning clarification, regulatory approach, and regulatory requirement for three–dimensional (3D)-printed medical devices (MDs). However, these are not officially new regulatory controls as these are composed of the authority’s current thinking, existing policies, and practices.
Background and Scope
3D Printing, or also known as Additive Manufacturing (AM), is the process of constructing an item using a digital model as a basis in a layer–by–layer manner, as opposed to the usual conventional subtractive manufacturing. Common examples of MDs manufactured using this method include non-invasive (e.g., prosthetic limbs), dental devices, surgical tools and guides, and implantable devices. These MDs are produced using technologies such as powder bed fusion, stereolithography, fused filament fabrication, and liquid–based extrusion. The current regulatory framework still applies to these devices, as well as traditionally-manufactured ones, based on risk classification, intended use/indications for use, and technological characteristics, regardless of the manufacturing process. They must also comply with the Essential Safety and Performance described in GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices.
This updated guideline is applicable to all MDs manufactured via AM/3D printing, excluding in-vitro diagnostic (IVD) MDs.
Categorization of 3D-Printed MDs
3D-printed MDs are categorized into two: mass–produced and custom-made.
a) Mass–produced MDs are standard sized, could be adapted to individuals, and are matched to the requirements of the patient. Example of a patient–matched MD is the acetabular guide, which is based on the patient’s specific anatomy.
b) Custom–made MDs are manufactured to accommodate the request of a qualified practitioner, and intended to be used to a particular individual, which is not adapted from mass-produced MDs. An example of a custom–made MD is an acetabular cup implant, where its construction, aside from the patient–specific anatomy, the practitioner requests specifications that are only applicable to that device.
For mass-produced MDs, the regulatory controls include:
- - dealer’s license requirements,
- - post-market obligations,
- - product registration (except for Class A devices)
Custom-made MDs controls are:
- - dealers’ license requirements
- - post-market obligations.
For mass-produced and custom-made MDs, the following guidelines and duties still apply:
- - GN-13: Guidance on Risk Classification of General Medical Devices
- - GN-15: Guidance on Medical Device Product Registration
- - GN-21: Guidance on Change Notification for Registered Medical Devices.
- - GN-02: Guidance on Licensing for Manufacturers, Importers, and Wholesalers of Medical Devices.
- - Post-marketing duties include reporting of adverse events, defects, and recalls to HSA and ensuring proper investigation is conducted to assure the safety of the device.
Basic considerations for the Common Submission Dossier Template (CSDT) for all 3D – printed MDs include the following:
- - Device Description,
- - Summary of Design Verification and Validation (V&V) Documents
- - Device Labelling
- - Manufacturer Information