EU MDR vs EU IVDR
The device pair — one for what you put in the body, one for what you test outside it.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
The MDR (2017/745) governs medical devices; the IVDR (2017/746) governs in-vitro diagnostic medical devices — tests performed on samples taken from the body. They are sibling regulations with parallel structures, but the IVDR introduced a far more demanding classification and notified-body regime for diagnostics than the directive it replaced, reclassifying most IVDs into higher-scrutiny classes.
| ASPECT | EU MDR | EU IVDR |
|---|---|---|
| What it covers | Devices acting in or on the body | Diagnostic tests on samples (blood, tissue, etc.) |
| Classification | Classes I, IIa, IIb, III (risk-based) | Classes A, B, C, D (risk-based; D highest) |
| Notified-body involvement | Required above Class I | Required for classes B–D — a major expansion vs the old IVDD |
| Evidence | Clinical evaluation + PMCF | Performance evaluation (scientific validity, analytical & clinical performance) + PMPF |
| Transition | Applied 2021, staggered legacy provisions | Applied 2022, with extended staggered deadlines by class |
| Shared machinery | EUDAMED, UDI, vigilance, PMS | EUDAMED, UDI, vigilance, PMS (same infrastructure) |
Apply MDR to devices that act in or on the body — implants, instruments, software as a medical device — using the I/IIa/IIb/III classification.
Apply IVDR to in-vitro diagnostics — assays, analysers, companion diagnostics — using the A/B/C/D classification, and plan early for notified-body capacity given how many IVDs are now up-classified.
Same architecture, different product families. The trap is underestimating the IVDR: under the old IVDD most diagnostics self-certified, but the IVDR pushes the majority into notified-body-assessed classes (B–D), and notified-body capacity is the binding constraint. If you make IVDs, the switch from “performance evaluation on paper” to scrutinised, evidence-heavy conformity assessment is the real change — not the shared EUDAMED/UDI/vigilance machinery it holds in common with MDR.
EU MDR vs EU IVDR: frequently asked questions
Common questions on how EU MDR and EU IVDR differ and when each applies.
What is the core difference between MDR and IVDR?
MDR covers medical devices used in or on the body; IVDR covers in-vitro diagnostic tests performed on samples taken from the body. They share regulatory infrastructure (EUDAMED, UDI, vigilance) but use different classification systems and evidence requirements.
Why is the IVDR considered more disruptive?
Because it dramatically increased notified-body involvement. Under the previous IVD Directive, the large majority of IVDs self-declared conformity; under the IVDR, classes B–D require notified-body assessment, so far more diagnostics face formal scrutiny — against limited notified-body capacity.
Do MDR and IVDR use the same classes?
No. MDR uses Class I / IIa / IIb / III. IVDR uses Class A / B / C / D, where A is lowest-risk and D is highest-risk (e.g., tests for transmissible agents in blood/organs).
Is software regulated under MDR or IVDR?
It depends on intended purpose. Software that provides information for diagnostic or therapeutic decisions on the body is generally MDR; software that qualifies as an in-vitro diagnostic (interpreting IVD results) falls under IVDR. The intended purpose drives the classification.