Theme Custom-Made, Adaptable and Patient-Matched medical devices
Target Audience Manufacturers
Products concerned MD
Documents mentioned MDR (EU) 2017/745

Article 2(3), 16(1)

Annex XIII




This document aims to answer questions related to custom-made devices in the framework of Regulation (EU) 2017/745 in the form of answers to 10 questions supported by bibliographic references and concrete examples. Clarifications are provided with the help of the IMDRF document on the definition of adaptable medical devices and patient-matched medical devices which do not fall under the category of custom-made and therefore under their specific regulatory regime. The hypotheses of “intermediate products” such as dental ceramics or modular components for prostheses or additive manufacturing are also addressed.