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EU MDR classification tool

Answer a few questions about your device and get its indicative EU MDR risk class (I, IIa, IIb, III) — with the exact Annex VIII rules that apply. Built on the same engine inside QMS Nordic.

1Your device

2Get your result

Intended use / purpose of the device

How long is it in continuous contact / use?

How does it interact with the body?

Characteristics

Active device (uses energy other than gravity / the body)

Contains software (incl. firmware)

Is software as a medical device (SaMD) / standalone software

In contact with the central circulatory system, heart, or CNS

Has a measuring function

Supplied sterile

Life-supporting (failure could cause death or serious harm)

Answer every question to continue.

Not regulatory advice. For orientation only — always confirm with a qualified regulatory professional or your Notified Body.