MDR vs IVDR — which applies?
Regulatory basis - MDR = Regulation (EU) 2017/745 | IVDR = Regulation (EU) 2017/746. Both regulations are mutually exclusive — a product is governed by one or the other, never both simultaneously.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
The fundamental split
| Regulation | Covers |
|---|---|
| MDR 2017/745 | Medical devices, accessories to medical devices, Annex XVI non-medical-purpose devices |
| IVDR 2017/746 | In vitro diagnostic medical devices and their accessories |
The split is determined entirely by the product's intended purpose and mode of use: is the examination performed in vitro on a human-derived specimen, or is the device used in some other way?
The primary test
Ask this question first:
Is the device intended to examine a specimen derived from the human body, outside the body, to provide diagnostic or monitoring information?
| Answer | Regulation |
|---|---|
| Yes — in vitro examination of human-derived specimens | IVDR 2017/746 |
| No | MDR 2017/745 (if it is a medical device at all) |
Decision flowchart
Is the product intended for use in human beings?
│
├─ NO → Not an MDR/IVDR medical device
│
└─ YES → Does it act principally by pharmacological/immunological/metabolic means?
│
├─ YES → Medicinal product (Directive 2001/83/EC)
│
└─ NO → Is it used in vitro on human-derived specimens
to provide diagnostic/monitoring information?
│
├─ YES → IVDR 2017/746
│
└─ NO → MDR 2017/745
Common scenarios
Clearly MDR
| Product | Reason |
|---|---|
| Hip implant | Implanted in the body |
| Insulin pump | Delivers therapy in the body |
| Cardiac monitor (wearable) | Measures in vivo physiological signals |
| MRI scanner | Imaging performed on the body |
| Surgical robot | Used on the body |
| Dermal filler | Injected into the body (Annex XVI) |
| Contact lens (cosmetic) | Used on the body (Annex XVI) |
| Wound dressing | Applied to the body |
| SaMD for radiology image analysis | Analyses in vivo imaging data |
Clearly IVDR
| Product | Reason |
|---|---|
| Blood glucose test strip | In vitro examination of blood specimen |
| PCR assay for infectious disease | In vitro examination of patient sample |
| BRCA genetic test | In vitro examination of tissue/blood |
| Blood typing reagent | In vitro compatibility testing |
| Urine pregnancy test | In vitro examination of urine specimen |
| Clinical chemistry analyser | Processes in vitro blood/urine samples |
| Companion diagnostic | Identifies patients from specimen |
| Histopathology analysis software | Examines tissue specimens in vitro |
Borderline — requires careful analysis
| Product | Issue | Resolution |
|---|---|---|
| Point-of-care blood glucose meter | In vitro, but used at bedside | IVDR — near-patient testing is still in vitro |
| Continuous glucose monitor (CGM) | Sensor worn on/in body; no specimen extraction | MDR — in vivo interstitial measurement |
| NGS sequencing platform | General-purpose instrument with IVD assay kits | IVDR for the IVD-intended configuration as a system |
| Smart toilet analysing urine | Wellness vs diagnostic claims | If diagnostic disease claims: IVDR; wellness only: likely neither |
| Microbiome analysis kit | Examines stool/saliva | If disease diagnosis/monitoring claims: IVDR |
Key pathway differences
| Topic | MDR | IVDR |
|---|---|---|
| Classification | Class I · IIa · IIb · III (Rules 1–22) | Class A · B · C · D (Rules 1–7) |
| Notified body required? | No for Class I (except Is/Im/Ir); Yes for IIa+ | No for Class A; Yes for most B, C, D |
| Clinical/performance evidence | Clinical evaluation (Art. 61, Annex XIV) | Performance evaluation (Art. 56, Annex XIII) |
| Post-market follow-up | PMCF | PMPF |
| PSUR required | Class IIb, III | Class C, D |
| Companion diagnostic rules | N/A | Class C minimum; EMA consultation required |
When you are still unsure
Consult the MDCG Borderline and Classification Working Group guidance. Key documents:
- MDCG 2022-5 — Borderline manual between MDR and other legislation
- MDCG 2019-11 — Software qualification and classification
National competent authorities can provide formal opinions. These are not binding EU-wide but are a recognised route to regulatory certainty.
Related pages
- What is a medical device?
- What is an IVD?
- What is not a medical device?
- Classification — MDR rules 1–22
- Classification — IVDR rules 1–7
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(1) | Medical device definition |
| IVDR Art. 2(2) | IVD definition |
| MDR Art. 1(8) | Interaction with medicinal product rules |
| MDCG 2022-5 | Borderline product guidance |
| MDCG 2019-11 | Software qualification guidance |