I’ll get into some of these later in the guide, but for now, I’d encourage you to read or at least bookmark these resources for easy reference. You’ll find them immensely helpful, especially if you’re wondering whether your software meets the definition of medical device software in the EU.
The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.
I’ll get into some of these later in the guide, but for now, I’d encourage you to read or at least bookmark these resources for easy reference. You’ll find them immensely helpful, especially if you’re wondering whether your software meets the definition of medical device software in the EU.
The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.