Quality Assurance

Under the EU Medical Device Regulation (MDR) 2017/745, your technical file is not just a collection of documents—it’s the complete evidence package that proves your device is safe, effective, and compliant. Without a well-prepared and well-maintained technical file, your CE marking approval is at risk, along with your access to the European market.

In the fast-paced and highly regulated medical device industry, risk management is not simply a compliance checkbox — it is a continuous, proactive process that underpins device safety, performance, and regulatory success. From the initial concept to post-market monitoring, effective risk management ensures that devices meet safety requirements, protect patient health, and maintain compliance with international standards such as ISO 14971:2019.

This article explores the role of risk management throughout the device lifecycle, explaining why it matters, how it is applied at each stage, and what best practices manufacturers can follow to remain competitive and compliant.

Medical device compliance in the UK and EU has become more complex following Brexit. With both the European Union Medical Device Regulation (EU MDR) and the UK Medical Devices Regulations 2002 (as amended) (UK MDR) now operating in parallel, manufacturers must understand how to comply with both regimes to maintain market access.

This guide provides a practical overview of how to approach compliance, highlighting key similarities and differences between the two frameworks and offering tips to streamline your regulatory strategy.

Navigating the European medical device regulatory landscape can be complex—especially with the introduction of the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746). One critical player in helping manufacturers, notified bodies, and regulatory authorities interpret and implement these regulations is the Medical Device Coordination Group (MDCG).

it’s a legal requirement. If you’re new to the industry, understanding ISO 13485 is a crucial first step in navigating compliance and building a strong quality management system (QMS). This beginner’s guide breaks down the essentials of ISO 13485 in simple, easy-to-understand terms.

In today’s digital world, information is one of the most valuable assets an organisation has. From sensitive customer data to proprietary business processes, protecting information is critical—not only to maintain trust, but to comply with legal and regulatory obligations.

The cosmetics industry is growing fast, with thousands of new products hitting the European market each year. But while creativity in beauty is exciting, safety must always come first. That’s where EU cosmetics regulation comes in.

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.