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: regulatory
3D printing at Point-of-Care
3D technology has found it’s way to the hospital and is significantly improving patient care. In the article below I highlight the opportunities and identify the risks of 3D printing in a hospital setting. It talks about regulatory and quality management aspects and links to helpful guidance documents.
Case management in personalized medical devices
Case Management in Patient-Specific Surgical Planning, Surgical Guides, and Custom-Made Implants Case management plays a vital role in the production and implementation of 3D-printed patient-specific surgical planning, surgical guides, and custom-made implants. Not only does it ensure streamlined operations, but it also helps achieve traceability—a fundamental requirement of a Quality Management System (QMS) under ISO …
Risks in medical 3D printing
Risks are everywhere! As part of your QMS, analyse your risks. It’s convenient to analyse the risks per step in the workflow below. Do this with a multidisciplinary team, so you can approach this from various angles. This workflow reflects the elements of the Ishikawa diagram, or 5M method: Sometimes you even see another M: …
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).