Can medical device software still be classified as Class I software under EU MDR 2017/745? There is an ongoing discussion about whether medical device software can be classified as Class I under EU MDR 2017/745. Here is my assessment based on EU MDR 2017/745, MDCG 2019-11,...
Introduction This blog explains the concepts of UDI, UDI-DI, and UDI-PI according to the EU Medical Device Regulation (MDR) and EU In-Vitro Diagnostic (IVDR) in more detail to help understand the differences and how to deal with them. UDI Definitions: 1. UDI (Unique Device Identifier) The UDI is a...
Understanding Intended Purpose - A Critical Element for Medical Devices and IVDs in the EU The intended purpose of a medical device or in vitro diagnostic device (IVD) is a fundamental concept in EU regulations. It plays a crucial role in device classification, conformity assessment, and...
"Placing on the market" vs "Making available on the market" The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) make important distinctions between 'making available on the market' and 'placing on the market' for medical devices and IVDs. Understanding these concepts...
SOP (Standard Operation Process) In the highly regulated medical device industry, processes and SOP's (Standard Operating Procedures) are indispensable. They help to increase quality and consistency in the development and production of products like Medical Devices. The main regulations and standards in this area are ISO...
SaMD - Software as a Medical Device This article provide a-depth overview of Software as a Medical Device (SaMD) and its regulatory landscape, focusing on FDA and EU regulations. Understanding SaMD Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as...
Standard Manufacturing in the Medical Device Industry: A Comprehensive Guide In the highly regulated medical device industry, "standard manufacturing" refers to the consistent and controlled production processes that ensure devices meet stringent quality, safety, and performance standards. This article aims to provide a clear understanding of...
Document Control in general Document control is a critical aspect of quality management systems in the medical device industry, as outlined in ISO 13485:2016 and reinforced by EU MDR 2017/745 and EU IVDR 2017/746. Here's an overview of document control requirements according to these standards:ISO 13485:2016...
Quality Assurance vs Quality Control In the medical device industry, ensuring the safety and effectiveness of products is paramount. This is achieved through two critical functions: Quality Assurance (QA) and Quality Control (QC). Although these terms are often used interchangeably, they refer to distinct processes that...
AI Diagnostic Dental In recent years, the field of dentistry has witnessed a remarkable transformation with the integration of artificial intelligence (AI) into diagnostic processes. AI diagnostic dental technologies are reshaping the landscape of oral healthcare, offering unprecedented accuracy, efficiency, and patient care. This article delves...