The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance) introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance provides more detailed examples, specifically includes software using artificial intelligence (AI), and addresses modular software and interoperability with electronic health records (EHRs) under the European Health Data Space (EHDS).
This blog post outlines these key updates and considers their potential impact on compliance obligations for software manufacturers.Continue Reading Revised guidance on classification of Medical Device Software in the EU