Abstract

The regulatory landscape in Europe for 3D-printed medical devices produced in healthcare facilities is quite challenging, mainly because of the lack of a holistic framework that effectively covers the device classifications defined in the EU Medical Device Regulation 2017/745. Against this background, the present study sets out to provide a methodological approach developed in the 3D Innovation Lab of the Humanitas Research Hospital by combining a detailed analysis of 3D printing techniques and application with a regulatory review of MDR, MDCGs, and relevant ISOs. The proposed workflow includes a full categorization of devices according to MDR classifications, along with the required documentation for each category, such as technical files, risk management reports, clinical evaluations, and conformity with Unique Device Identification (UDI) procedures and the European Database on Medical Devices (EUDAMED). This research also details the documentation required at the facility level, such as records from quality and risk management systems, logs of device tracking, and post-market surveillance plans with specified timelines that will enable prompt compliance. This work will interest healthcare organizations looking to implement 3D printing technologies while ensuring continued compliance with regulatory requirements and operational efficiency and highlights the great value that such facilities can add to hospitals and their patients.

Keywords:MDR 2017/745; Regulatory compliance; 3D printing; Healthcare facilities; Medical devices; Device classification; Quality management systems; Certification processes; Risk management; Clinical evaluations

Abbreviations:MDR: Medical Device Regulation; 3DIL: 3D Innovation Lab; QMS: Quality Management System; RMS: Risk Management System; PMS: Post Market Surveillance; UDI: Unique Device Identification; EUDAMED: European Database on Medical Devices