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
US FDA vs EU MDR: Key differences in medical device classification
Selling a medical device in both the United States and the European Union means navigating two different regulatory systems. Although both rely on risk-based classification, the criteria, terminology, and approval processes vary significantly. Misunderstanding these differences can lead to delays, [...]
Authorized and Legal Representative: key roles for compliance
In the global regulatory environment for medical and in vitro diagnostic devices, manufacturers operating outside a given market are often required to appoint a local representative. Two distinct roles exist in this context: the Authorized Representative and the Legal Representative. [...]
Why the UK is moving toward EU-aligned standards for IVDs
The UK’s decision to adopt EU Common Specifications for high-risk in vitro diagnostic (IVD) devices reflects a regulatory shift toward performance-based requirements and alignment with internationally recognised standards. This approach supports public health objectives, replaces legacy mechanisms such as the [...]
