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
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare delivery. Software is no longer just an accessory to medical devices, it can operate as a medical device on its own. To guarantee safety and performance, the Therapeutic Goods Administration [...]
