A guide to ISO 13485

If you’re entering the medical device market or managing regulatory compliance for the first time, one term you’ll hear frequently is UDI – Unique Device Identification. This system is critical to global regulatory frameworks and is rapidly becoming a non-negotiable requirement for manufacturers worldwide.

In this comprehensive beginner’s guide, we’ll explain what UDI is, why it exists, how it works, what the regulatory requirements are in major markets, and how to implement it effectively within your organisation. We’ve also included answers to some frequently asked questions to help clarify common uncertainties.

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.