All medical devices, including personalized/custom-made (patient-matched) devices, devices made under the healthcare institution exemption (point-of-care manufacturing) and 3D printed medical devices have to adhere to the applicable parts of Annex I of the MDR. This IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2) guidance document might help to make sense of the Essential Principles of Safetyand Performance:
Tag: medical devices
Guidance PMD
Personalized Medical Devices – Regulatory Pathways Last week, the IMDRF released the second edition (2023) of document IMDRF/PMD WG/N58. The previous edition dated from 2020. In this latest version, they elaborate a bit more on the concept of the Medical Device Production System (MDPS).