Do DiGA changes need to be reported to BfArM prior to implementation?

Question

Are manufacturers of DiGAs (Digital Health Applications) required to report changes to BfArM before implementing them? How do these requirements compare to those in MDCG 2020-3? What are the risks if changes are not reported?

Dr. Oliver Eidel · Accepted Answer

BfArM requires DiGA manufacturers to report and align on changes prior to implementation. They have published a checklist for self-assessment to help decide which changes are significant and need reporting. Compared to the MDCG 2020-3 decision tree, the BfArM checklist considers more types of changes as significant and reportable. If you fail to report significant changes, you risk financial penalties and your DiGA listing could be at risk.

During provisional listing, you're expected to collect data for positive care effects in a clinical study. It's generally advised not to implement changes that could affect your device during this period, as it may influence your study outcomes and compliance status.

Answer

The BfArM has a pretty strict interpretation that a DiGA should be basically finished when you submit your application. Changes to things like IT security or aspects not affecting the medical core are usually fine, but anything that might affect the medical purpose or care effect could be considered significant. The definition is a bit ambiguous, so if BfArM disagrees with your assessment, they might claim even minor changes are significant and require reporting.

Answer

BfArM assumes you are testing the same positive care effect both in your preliminary (statistical data analysis) and final (clinical study) listings. We avoid making any changes that could make BfArM think the positive care effect has changed, because that could mean they require a new or updated study.

Do DiGA changes need to be reported to BfArM prior to implementation?

3 Answers

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