EU Regulations

Understand the essential requirements for placing cosmetic products on the UK and EU markets, including Responsible Person obligations, CPSRs, PIFs, product notification, labelling, claims, GMP and post-market compliance.

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.

Learn how medical device systems and procedure packs are regulated under Article 22 of the EU Medical Device Regulation (EU MDR 2017/745). This guide explains the differences between systems and procedure packs, the responsibilities of producers, when a new medical device is created, labelling requirements, conformity assessment and ongoing regulatory compliance.

Unique Device Identification (UDI) is a fundamental requirement under modern medical device regulations, helping manufacturers improve product traceability, strengthen patient safety and support effective post-market surveillance. Whether you’re placing devices on the EU, UK or US market, understanding UDI is essential for achieving and maintaining regulatory compliance.

This guide explains what Medical Device UDI is, how the system works, the regulatory requirements in major markets and the practical steps manufacturers can take to implement a compliant UDI system within their organisation.

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 the European market requires careful planning and compliance with the EU Medical Device Regulation (EU MDR 2017/745). This guide outlines the key stages of the regulatory journey, from device determination and classification through Quality Management Systems, Technical Documentation, CE marking and ongoing Post-Market Surveillance.

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.