Notes · 30 September 2026

MDR or IVDR on an EUDAMED device

The legislation field on a public EUDAMED device is MDR or IVDR. It is the regulation the manufacturer registered, not a second market status.

A public device record names the legislation it was registered under. That is either Regulation (EU) 2017/745, the MDR, or Regulation (EU) 2017/746, the IVDR. People search “MDR or IVDR” when a label, a declaration of conformity, and a tender annex do not use the same words.

What the field is for

MDR covers medical devices. IVDR covers in vitro diagnostic medical devices. The legislation is not the market status and not the risk class. A device can be “on the market” under either regulation. The class scales differ: MDR runs from class I to class III, IVDR from class A to class D. Reading a class letter as if it were a Roman numeral, or the reverse, mis-states the device.

System and procedure packs are registered under the MDR. The UDI guidance does not offer IVDR as the legislation for that pack registration. A pack can contain devices. The pack’s own UDI-DI is still a pack record.

What a public page will not decide

The legislation value is the one the manufacturer submitted. UdiWatch copies it onto the device page when the public response includes it. We do not reclassify a device because the trade name sounds diagnostic, and we do not treat a missing legislation field as proof that the device sits outside both regulations. An empty field is an empty field.

If you are comparing two codes, check legislation, risk class, and market status as three columns. A change in any one of them is a different event. The Covered CP Stent page is one public MDR-shaped record you can open without an account. Whether a specific code you hold is MDR or IVDR is what its own page says, not what a similar product says.

More notes

Not an official European Commission page. Public device and actor pages on this site repeat fields the register already publishes.