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Introduction Navigating the European Union’s Medical Device Regulation (EU MDR 2017/745) is a complex endeavor for manufacturers aiming to achieve CE marking. The EU MDR introduces stringent requirements, emphasizing patient safety and device efficacy. As regulatory consultants, we’ve observed recurring mistakes that can impede the certification process. This article outlines these common pitfalls and offers […]

Introduction The European Union Medical Device Regulation (EU MDR) 2017/745 has significantly transformed the regulatory landscape for medical devices. One of its pivotal components is the requirement for a comprehensive Clinical Evaluation (CE), which ensures that medical devices meet stringent safety and performance standards before entering the EU market.  Understanding Clinical Evaluation Under MDR Clinical

Introduction The integration of Artificial Intelligence (AI) into medical devices has revolutionized healthcare, offering enhanced diagnostics, personalized treatments, and improved patient outcomes. However, with innovation comes the responsibility to ensure safety, transparency, and ethical use. Recognizing this, the European Union introduced the Artificial Intelligence Act (AI Act), formally known as Regulation (EU) 2024/1689, establishing a

Introduction When it comes to entering the European Union (EU) market, CE marking is a crucial certification that signifies a medical device’s compliance with EU regulations. For medical device manufacturers, the EU Medical Device Regulation (MDR 2017/745) sets out strict guidelines to ensure safety and performance before marketing a device in Europe. As a medical

Introduction Navigating the European Union (EU) market requires medical device manufacturers to understand the pivotal role of Notified Bodies (NBs) in the CE marking process. This article offers a comprehensive guide on the function of NBs, criteria for selecting the appropriate one, and strategies for effective collaboration to ensure compliance with EU regulations. Understanding Notified

Introduction In the competitive landscape of medical device manufacturing, securing access to the European market is a pivotal step. Central to this process is obtaining the CE marking, a certification that signifies compliance with European Union (EU) regulations. This guide provides an in-depth exploration of CE certification, its significance, and the steps manufacturers must undertake