News and Updates
MEDICA 2026: Meet CMC Medical Devices in Düsseldorf
CMC Medical Devices will be exhibiting at MEDICA 2026 in Düsseldorf from 16–19 November. Find us at Hall 6 – Stand D33. As an international medical device and IVD regulatory partner, we look forward to meeting manufacturers, partners and [...]
MDD 93/42/EEC Explained: Legacy Devices and the Transition to MDR
For nearly three decades, Council Directive 93/42/EEC (MDD) provided the regulatory framework for most medical devices placed on the European market. Adopted in 1993, it established common safety and performance requirements and introduced the CE marking framework for medical [...]
EU MDR (2017/745) Fully Explained: Requirements, Timelines & Compliance
The European Union Medical Device Regulation (EU MDR) 2017/745 is the main regulatory framework governing medical devices placed on the European Union market. It establishes requirements for the safety, performance, quality, traceability, and ongoing monitoring of medical devices throughout [...]
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 [...]
