Articles from practice

With the European Health Data Space (EHDS), electronic health record systems acquire obligations of their own, including CE marking and registration. Medical devices are not automatically covered. They are brought in, however, as soon as the manufacturer claims that they are interoperable with such systems. This article shows which software is affected, what an interoperability claim triggers and which deadlines apply.

Teams building software with a medical intended purpose know the MDR. For AI-enabled products, a second body of law has applied since 2024: the AI Act. Both operate in parallel, and for many medical devices the AI Act bites precisely where a notified body already assesses. This article shows when an AI medical device counts as high-risk, how the two conformity routes connect, and which deadlines apply.

Whether an application is regulated as a medical device is decided by its intended purpose, not by its technology. The same code can be a harmless evaluation tool or software requiring conformity assessment, depending on what the manufacturer says it should do. This article shows what the classification hangs on and how to make it early and deliberately.