EUDAMED
The European database on medical devices: what has to be registered, by whom, and when. Registration follows the economic-operator role — so the question of who registers is answered by the question of who you legally became.
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…
Read the article →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…
Read the article →The May 2026 EUDAMED Deadline: What It Means for Digital Health Technologies in Clinical Trials
The first EUDAMED modules became mandatory on 28 May 2026 — is the wearable sensor in your trial registered, and did it need to be? What happens to your EU clinical trial if the device manufacturer…
Read the article →“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint? Why do so many sponsors fail…
Read the article →A document appears here because it names EUDAMED in its own text. Nothing is inferred: this is what we have actually written about it.