Here, you will find helpful information on different regulatory affairs related topics in the medical device field.
From QSR to QMSR: What’s Changing and How to Prepare The FDA is officially replacing its long-standing Quality System Regulation (QSR, 21 CFR Part 820) with the new Quality Management System Regulation (QMSR) — and the clock is ticking.2017/745, MDCG 2019-11, MDCG 2020-16, and MDCG...
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...
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)...
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,...
“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...
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...
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...
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...
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...
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...
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...
Introduction The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 marks a pivotal transformation in the regulatory framework for in vitro diagnostic (IVD) medical devices within the European Union. Introduced to enhance safety, performance, and transparency, the IVDR represents a major overhaul from the In Vitro...
A Comprehensive Guide to Medical Device Sales: From Development to Market In today’s rapidly evolving healthcare landscape, the sale of medical devices represents a crucial aspect of the medical industry, contributing significantly to advancements in patient care and treatment. For startups entering this competitive market,...
MDCG 2020-3 – Guidance on significant changes In May 2023 the Medical Device Coordination Group updated the MDCG document MDCG 2020-3 Rev.1. This document provides guidance on significant changes concerning the transitional provisions under Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR). This...
MDCG 2021-5 – Guidance on standardization for medical devices On July 2024 the EU Commission updated the MDCG document MDCG 2021-5 Rev.1. The document provides guidance on standardization for medical devices in the European Union. It covers various aspects related to standards in the medical devices...
EU AI Act 2024/1689 and its impact on Medical Devices: Legislative Background: The legislation background of this EU AI Act includes the Treaty on the Functioning of the European Union (TFEU) and specific regulations such as Regulation (EU) 2024/1689 of the European Parliament and of...
EUDAMED and all you need to know EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. Its primary purpose is to enhance market transparency and oversight in the medical device field by providing a comprehensive repository...
An In-Depth Guide to Understanding the Advantages for Regulatory Affairs Professionals In the fast-paced world of regulatory affairs within the global medical device industry, staying up to date with complex and ever-changing regulations is a huge challenge. Amidst this complexity, a powerful new technology has...
🌍 Stay Ahead in the Medical Device World! 🌍 Navigating the intricate landscape of EU medical device regulations can be challenging. Whether you’re delving into the nuances of MDR, IVDR, or exploring the frontier of AI in medical devices, we’ve got you covered. ✨ Why...
An In-Depth Guide for Manufacturers Post-market surveillance (PMS) is a critical regulatory requirement for medical devices and in vitro diagnostic devices within the European Union. The EU MDR 2017/745 and IVDR 2017/746 lay down specific guidelines for post-market surveillance to ensure ongoing safety, performance, and...
What is MDCG? The MDCG ensures that regulatory authorities in the European Union member states have a forum for coordinating their efforts and sharing best practices related to medical device regulations. This includes the implementation and application of the MDR and the IVDR. This group...
Introduction The medical device industry is a rapidly evolving sector that is heavily regulated to ensure the safety and efficacy of products. Within this industry, the role of a Regulatory Affairs Specialist and Manager is crucial. These professionals navigate the complex regulatory landscape, ensuring that...