CMC CONSULTING GROUP is an international group of consulting firms focused on regulatory affairs for medical devices.
Based in Spain, it has established various offices in the United Kingdom, Spain, Switzerland, China, Australia, and the USA. With professional technical teams from various fields around the world, it can provide personalized services for international clients based on the actual conditions of the manufacturer.
News and Updates
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 [...]
