Articles from practice

The revised guideline on good clinical practice has applied in the EU since July 2025, and its Annex 2 follows on 15 January 2027. It no longer treats computerised systems as a side issue but as part of the data responsibility of sponsor and trial site. This article sets out what E6(R3) requires of software in clinical trials, what Annex 2 adds for wearables, apps and data from routine care, and how to align the effort with the risk.

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.

In regulated environments, software must be validated — and many teams experience this as a mountain of paperwork that slows every small change. It need not be so. The risk-based approach has been the state of the guidelines for years: effort where the risk sits, and restraint where there is none. This article shows what validation really requires and how GAMP 5 and EU GMP Annex 11 support the lean route.

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.

An AI pilot promises quick wins and is still stuck months later. The cause is rarely the model, but the data beneath it: inconsistent keys, duplicates, missing units. This article describes why data maturity is the actual project — and when AI honestly does not help.

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.