Implementation of a digital chain for the design and manufacture of implant-based surgical guides in a hospital setting.

ABSTRACT

The digital revolution has led to many recent developments in implantology that have considerably facilitated implant planning and the creation of surgical guides. The purpose of this article is to explain how we set up a digital workflow in a large city hospital and how we met the requirements of the European regulations on the production of custom-made devices in a medical establishment. The internal manufacture of a surgical guide complied with European regulation EU/2017/45 concerning medical devices. This regulation allowed the hospital to create these medical devices locally without CE marking. However, the hospital must be declared as a manufacturer of medical devices and comply with the general requirements in terms of safety and performance related to the manufacture and use of medical devices. In addition, hospitals are large structures involving many different actors. Each step of the digital workflow, which included both the patient course and the creation of the surgical guide, was thus adapted to European regulations by considering local constraints.