MDR classification tool
We turned the MDR Annex VIII rules into step-by-step questions. Your preliminary class updates live on the right as you answer.
This tool is for preliminary assessment and does not replace MDCG 2021-24 guidance. Final classification requires expert review of intended purpose, anatomical site and duration, and acceptance by your notified body. Your selections never leave your browser.
FAQ
How many device classes are there under the MDR?
Four: Class I (low risk), Class IIa, Class IIb and Class III (highest risk). Class I includes sub-groups for sterile (Is), measuring (Im) and reusable surgical instruments (Ir).
Which criteria determine the class?
Intended purpose, how the device contacts the body (invasive or not), duration of use (transient, short-term, long-term), anatomical site, whether it is active, and whether it contains medicinal substances, tissues or nanomaterials.
What if more than one rule applies?
Under MDR Annex VIII Section 3.5, if several rules apply, the strictest rule resulting in the higher class applies.