Guides and Advice

Risk management is not a one-time regulatory exercise—it is a continuous process that spans the entire medical device lifecycle. From initial concept and design through manufacturing, market launch, Post-Market Surveillance (PMS) and product retirement, manufacturers must continually identify hazards, evaluate risks and update their Risk Management File as new information becomes available. This guide explains how risk management supports every stage of the device lifecycle and why it is fundamental to compliance with ISO 14971, the EU MDR, EU IVDR and UK Medical Devices Regulations.

Medical device manufacturers placing products on both the European Union and Great Britain markets must navigate two distinct regulatory frameworks: the EU Medical Device Regulation (EU MDR) and the UK Medical Devices Regulations 2002 (UK MDR).

While the two regimes share many underlying principles, important differences exist in areas such as market access, conformity assessment, regulatory representation, device registration and post-market surveillance. This practical guide compares the EU MDR and UK MDR, explains the key requirements for each market, and outlines how manufacturers can develop an efficient compliance strategy for both the EU and Great Britain.

Understand what MDCG guidance documents are, why they matter under the EU MDR and IVDR, and how manufacturers can use them to support classification, technical documentation, clinical evidence, post-market surveillance and ongoing compliance.

ISO/IEC 27001 provides an internationally recognised framework for protecting sensitive information and managing information security risks. This beginner’s guide explains ISO 27001:2022, Information Security Management Systems (ISMS), risk assessments, Annex A controls, internal audits and the certification process.

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.