Medical Device Post-launch

When medical device manufacturers hear about ISO 13485 certification, it’s often described as a requirement — a hurdle to market entry. But treating ISO 13485 as nothing more than a checkbox misses its true value.

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.