News and Updates
EUDAMED UDI/Device Module: Device Data and Registration Requirements
EUDAMED UDI/Device registration is an important requirement for manufacturers placing medical devices and in vitro diagnostic medical devices (IVDs) on the European Union market. The UDI/Device module provides information about devices placed on the EU market and supports their [...]
EUDAMED Roll-Out: Timeline, Mandatory Modules and Key Deadlines for Manufacturers
EUDAMED, the European Database on Medical Devices, is now entering a new phase. Since 28 May 2026, four EUDAMED modules have been mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. For manufacturers of [...]
ISO 20916 Explained: Clinical Performance Studies for IVDs
Demonstrating clinical performance under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) requires robust scientific evidence generated through methodologically sound and ethically compliant clinical performance studies. While the IVDR outlines the overarching legal requirements for clinical evidence, [...]
EUDAMED Registration – A Comprehensive Guide for Manufacturers
EUDAMED registration is an important part of placing and managing medical devices on the European Union market under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The European Database on Medical Devices (EUDAMED) brings [...]
RAPEX / EU Safety Gate: How Unsafe Products Are Flagged and What It Means for You
The European Union operates one of the world's most rigorous regulatory frameworks to protect consumers and patients from non-compliant or dangerous products. At the core of Europe's rapid response strategy against non-food dangerous goods is the RAPEX system, officially [...]
FDA 510(k) Clearance: Process, Timeline and Common Pitfalls
Entering the United States healthcare market represents a massive growth opportunity for medical device manufacturers worldwide. However, gaining access to this market requires navigating strict regulatory pathways overseen by the U.S. Food and Drug Administration (FDA). For the vast [...]
COFEPRIS Medical Device Registration in Mexico: A Step-by-Step Guide
Mexico is one of the largest healthcare markets in Latin America. To sell medical devices or in vitro diagnostics (IVDs) in Mexico, foreign manufacturers must secure a Sanitary Registration (Registro Sanitario) from COFEPRIS (Comisión Federal para la Protección contra Riesgos [...]
EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire regulatory strategy under the European Medical Device Regulation (EU) 2017/745 (MDR). Specifically, this classification dictates your compliance pathway in the European Union. Consequently, it impacts clinical data requirements and Notified [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means dealing with a barrage of redundant Quality Management System (QMS) audits. For manufacturers looking to expand globally, this replication of effort consumes valuable time, capital, and resources. The Medical Device [...]
