A guide to ISO 13485

The In Vitro Diagnostic Regulation (EU IVDR) 2017/746 has brought about a significant transformation in the regulatory framework for IVD devices across Europe. One of the most crucial components of this regulation is Article 10, which outlines the general obligations of manufacturers.

As IVD manufacturers work to meet new compliance expectations, understanding the structure and impact of Article 10 is essential—not only for regulatory approval but also for maintaining ongoing access to the EU market.

The European Union Medical Device Regulation (EU MDR) 2017/745 is a comprehensive regulatory framework that governs the safety and performance of medical devices in the EU market. Among its core provisions, Article 10 – General Obligations of Manufacturers – serves as a foundational pillar that shapes how manufacturers bring their products to market and manage them throughout their lifecycle.

The European Union Medical Device Regulation (EU MDR) has become a crucial framework for ensuring the safety and performance of medical devices in the EU market. For companies entering the medical device sector or seeking to comply with the latest regulatory requirements, understanding the fundamentals of MDR is essential. In this guide, we’ll break down the basics of MDR and what it means for manufacturers, importers, distributors, and authorised representatives.

Navigating the complex world of in vitro diagnostic regulations can be daunting, especially for those new to the medical device industry. The In Vitro Diagnostic Regulation (IVDR), introduced by the European Union, is a critical framework that ensures the safety, performance, and quality of in vitro diagnostic (IVD) devices within the EU market. This beginner-friendly guide breaks down the essentials of IVDR, offering insights on its key components, classification rules, and practical steps for compliance.