Quality Assurance

Personal Protective Equipment (PPE) plays a vital role in keeping workers safe across many industries. From healthcare and construction to agriculture and manufacturing, PPE is used to reduce exposure to hazards that can cause injury or illness.

The European Union Medical Device Regulation (EU MDR) 2017/745 significantly reshaped the regulatory landscape for medical devices in Europe. One area that continues to cause confusion for manufacturers, distributors, and assemblers alike is the regulation of system and procedure packs. These are specific types of medical device groupings that, while not always requiring full CE marking as a new device, are still tightly regulated under Article 22 of the MDR.

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) is the regulatory framework governing medical devices placed on the European market. Introduced to enhance patient safety, improve transparency, and strengthen clinical evidence requirements, the MDR represents the most significant change to European medical device legislation in decades.

For manufacturers, importers, distributors, authorised representatives and regulatory professionals, understanding the MDR is essential for achieving and maintaining market access in Europe. This guide provides a comprehensive overview of the regulation, its requirements and the practical steps organisations must take to achieve compliance.

The In Vitro Diagnostic Regulation (IVDR) has transformed the regulatory landscape for diagnostic devices in Europe. Whether you are developing a new in vitro diagnostic medical device, transitioning a legacy product from the IVDD, or preparing for CE marking, understanding the requirements of Regulation (EU) 2017/746 is essential. This comprehensive guide explains IVDR classification, manufacturer obligations, performance evaluation, technical documentation, conformity assessment, post-market surveillance, and the practical steps needed to achieve and maintain compliance within the European market.

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).