The paper deals with the standardisation and regulatory context of Machine-to-Machine communications and the changes they cause in an electronic communications ecosystem. Research, innovation and market positioning of Machine-to-Machine communications in addressing global societal challenges is presented. Standardisation and adoption of interoperable standards are elaborated from the view of competition, investment and market development. Numbering and addressing, roaming, privacy and data security, and spectrum are discussed in terms of activities to be undertaken by the national regulatory authority. A case study on Machine-to-Machine communications in Croatia is given.