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Standards Development
This document specifies general requirements for non-active personalized surgical implants, hereinafter referred to as personalized implants, and their accessoires and instrumentation. This document does not apply to dental implants, dental restorative materials, trans endodontic and trans radicular implants, intraocular lenses, and implants utilizing viable tissues.
This document specifies requirements for intended function, design features, personalized design process, materials, design verification, process validation, manufacturing, cleaning, packaging, sterilization, clinical evaluation, post market surveillance and provision of information by the manufacturer, as well as test methods to demonstrate compliance with these requirements.
Personalized surgical implants are designed and manufactured based on the anatomical characteristics and individual needs of each patient. Among them, there are those that are defined as "custom-made" and those defined as "patient-matched". This differentiation is established based on differences in the patient's needs, in the concept of the process of personalizing devices to patients, and in the regulatory consequences related to these contexts. The IMDRF (International Medical Devices Regulations Forum), an international entity that brings together medical device regulators, first proposed this differentiation in the document Personalized Medical Devices – Regulatory Pathways, IMDRF/PMD WG/N58 FINAL:2024.
The goal of this proposed document will be to support manufacturers in applying the various usual processes required to manufacture an implant to the specific case of personalized implants. Furthermore, the document will aim to provide guidance on which information and additional processes will be needed to personalize a device. Finally, the document will investigate differences between such processes for “custom-made”, “patient-matched” and “mass-produced” implants.
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