Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
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2 articles tagged “Economic operators”
7 Jul 2026
Not in EUDAMED? If You Import the Device, the Obligations Are Already Yours
Who is the importer of record for the devices in your trial — and does that person know it? If a device on your study isn’t in EUDAMED, can you still legally…
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16 Apr 2026
Navigating CE Marking and Global Compliance for DHTs in Clinical Trials
Does your CE mark actually protect you outside the EU? Most sponsors assume it does — until their US arm hits an IDE requirement. What happens when the MHRA…
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