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
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 [...]
