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 Diagnostic...
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, understanding...
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 document...
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 sector...
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 the Council....
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 of...
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 emerged...
🌍 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 Subscribe to...
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 quality...
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 also...