The European Commission published its long-awaited <media 250>guidelines on the qualification and classification of medical software</media> on 23 January 2012. This essential document will help our industry and all stakeholders to assess which standalone software should be considered as medical devices, by establishing classification criteria and providing illustrative examples. COCIR will now urge all EU Member States to follow these guidelines which should be updated on a continuous basis -as this technology is evolving rapidly. It is crucial that there is a common understanding of which software fall under EU or international regulations on medical devices, and to reduce legal uncertainty that may hamper free movement of healthcare products across Europe and worldwide