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
How to write an EU Declaration of Conformity?
Updated June 2025 What is an EU Declaration of Conformity? An EU Declaration of Conformity (DoC) is a legal document in which the manufacturer states that their device complies with the applicable European regulations (MDR or IVDR). It must be [...]
EU Health Technology Assessment: public consultation and Joint Scientific Consultations now open
The implementation of the EU Health Technology Assessment (HTA) Regulation has reached a crucial stage. In June 2025, the European Commission introduced two important initiatives. These developments directly affect developers of medical devices, in vitro diagnostic devices, and medicinal [...]
Sterile gloves, sterile devices and patient transport equipment: what changed in 2025
In 2025, the European Commission introduced a new set of harmonised standards under the MDR (EU) 2017/745 and IVDR (EU) 2017/746 frameworks. These updates directly affect MDR technical documentation required for compliance and market access. If you manufacture single-use medical [...]
