Regulatory Insights

Updates and practical guidance on medical device regulations, quality systems and global market access.

European Regulations

Understanding the EU MDR: What Manufacturers Need to Know in 2025 and Beyond

The European Union Medical Device Regulation (EU MDR 2017/745) has fundamentally transformed how medical devices are brought to market in Europe. Unlike the previous Medical Device Directive (MDD), which allowed manufacturers to self-certify Class I devices and placed greater responsibility on manufacturers for conformity, the MDR introduces stricter requirements for clinical evidence, post-market surveillance, and Notified Body oversight.

8 minutesRead article

Quality Management Systems

ISO 13485:2016 vs. FDA QMSR: What Changed and Why It Matters

On February 2, 2026, the U.S. Food and Drug Administration (FDA) implemented the Quality Management System Regulation (QMSR), replacing the long-standing Quality System Regulation (QS Regulation, 21 CFR Part 820). This represents one of the most significant changes to FDA medical device oversight in decades.

7 minutesRead article

Sustainability & Compliance

EcoVadis Assessments: A Practical Guide for Medical Device Suppliers

Major healthcare customers increasingly require their suppliers to demonstrate sustainability performance through platforms like EcoVadis. With over 150,000 companies assessed globally, EcoVadis has become a de facto standard for supplier sustainability evaluation.

6 minutesRead article

Global Market Access

Medical Device Registration in Saudi Arabia: A Step-by-Step Guide

The Kingdom of Saudi Arabia represents one of the most significant medical device markets in the Middle East. With the Saudi Food & Drug Authority (SFDA) implementing robust regulatory requirements, manufacturers must navigate a structured registration process to access this market.

7 minutesRead article

Audits & Compliance

Unannounced Audits Under MDR: Are You Prepared?

Under the EU Medical Device Regulation, Notified Bodies are required to conduct unannounced audits of manufacturers and, where applicable, their suppliers and subcontractors. These audits are designed to verify that day-to-day operations consistently reflect the approved quality management system and technical documentation.

5 minutesRead article

Global Market Access

Medical Device Registration in Australia and New Zealand: An Overview

Australia and New Zealand offer significant market opportunities for medical device manufacturers. While both countries have distinct regulatory frameworks, there are important linkages that can streamline market entry.

6 minutesRead article

Regulatory Compliance

The Importance of UDI in Global Medical Device Regulation

Unique Device Identification (UDI) has become a cornerstone of medical device regulation worldwide. From the EU to the USA, Saudi Arabia to Australia, regulators are implementing UDI systems to enhance traceability, improve post-market surveillance, and strengthen patient safety.