Quality Assurance

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.

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.

Bringing a medical device to market in the European Union is a complex process. With the implementation of the EU Medical Device Regulation (MDR) 2017/745, manufacturers must follow a detailed regulatory roadmap to achieve CE marking and ensure continued compliance.

companies operating in regulated sectors such as medical devices, healthcare, and life sciences, protecting sensitive information—whether patient data, design documents, or clinical trial results—is not only critical for business continuity but also required under stringent regulatory obligations. This is where ISO/IEC 27001, the international standard for Information Security Management Systems (ISMS), comes into play.

Ensuring safety and efficacy is paramount for medical devices. Manufacturers aiming to market their products within the European Union must navigate a complex regulatory landscape. One of the most critical aspects of this process is obtaining CE marking—a declaration that a product complies with all relevant EU legislation. Central to this pathway is the involvement of Notified Bodies (NBs).

Medical device manufacturers aiming to market their products in the European Union must navigate a complex regulatory landscape. At the heart of this framework is the EU Medical Device Regulation (MDR) 2017/745, which replaced the Medical Device Directive (MDD). One of the most critical components of this regulation is the General Safety and Performance Requirements (GSPRs), outlined in Annex I of the MDR.

Navigating the complex landscape of medical device regulations in the European Union can be a daunting task. If you’re planning to bring a medical device to the EU market, compliance with the EU Medical Device Regulation (MDR) 2017/745 is not optional — it’s essential.