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Crosswalk
IVDR to MDR crosswalk
28 concept-by-concept mappings between Regulation (EU) 2017/746 (IVDR) and Regulation (EU) 2017/745 (MDR), with article references, links to the primary text, and notes on where the two regulations diverge.
Section 1
Foundations & scope
The regulations themselves, their classification systems, and general safety and performance requirements.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Regulation | EU In Vitro Diagnostic Regulation | EU Medical Device Regulation | Sister regulations adopted the same day. Structure and article numbering deliberately parallel where the underlying concept is shared. |
| Device classes | IVDR Risk Classes A–D | MDR device classes | Both are risk-based, but rule sets differ. IVDR uses 7 classification rules focused on intended use and public-health impact; MDR uses 22 rules focused on invasiveness, duration, and active/non-active status. |
| General safety and performance requirements | General Safety and Performance Requirements (IVDR) | General Safety and Performance Requirements | Same three-chapter structure (general, design/manufacture, information supplied). IVDR Chapter II is IVD-specific (analytical/clinical performance); MDR Chapter II covers device design, radiation, and interoperability. |
| Common Specifications | Common Specifications (IVDR) | Common Specifications | Identical mechanism and legal force in both regulations. Under IVDR, CS are dominant for Class D (see Reg (EU) 2022/1107); under MDR they are used for Annex XVI non-medical-purpose products. |
Section 2
Conformity assessment
The routes and controls a manufacturer follows to place a device on the EU market.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Conformity assessment routes | IVDR Conformity Assessment Routes | MDR conformity assessment | Annex numbering is aligned. Notified-body involvement moved from ~20% under IVDD to >80% under IVDR; MDR increases scope of NB oversight but from a higher baseline. |
| Notified body | IVDR Articles 31-46 | Notified Body | Designation is regulation-specific: an NB designated under MDR is not automatically designated under IVDR. Manufacturers with both device types need an NB that holds both scopes or must engage two bodies. |
| Highest-risk scrutiny | Notified Body Scrutiny (IVDR Class D) | CECP scrutiny | IVDR scrutiny targets novel Class D IVDs; MDR Clinical Evaluation Consultation Procedure (CECP) targets implantable Class III and certain Class IIb active devices. Same 60-day expert-panel mechanism. |
| Companion diagnostic route | Companion Diagnostic (IVDR) | No MDR equivalent - | CDx is IVDR-only. Manufacturers of drug-device combination products may face parallel MDR Article 117 obligations for the device constituent, but that is a separate mechanism. |
| Batch verification (highest risk) | Class D Batch Verification (IVDR) | No direct MDR equivalent - | Pre-release EU RL batch testing exists only under IVDR for Class D. MDR relies on post-market surveillance and market surveillance authority sampling for equivalent oversight. |
| Health-institution exemption | In-House IVDs (Article 5(5)) | Health-institution exemption | Same article number and conditions in both regulations: manufactured and used only within a single EU health institution, non-industrial scale, documented justification of unmet need. |
Section 3
Clinical / performance evidence
Evidence generation before market entry and the studies used to build it.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Evidence framework | IVDR Performance Evaluation | Clinical Evaluation Plan | IVDR performance evaluation rests on three pillars (scientific validity, analytical performance, clinical performance). MDR clinical evaluation rests on state-of-the-art, clinical data, and benefit-risk. Both produce a living report updated throughout the lifecycle. |
| Scientific / clinical basis | Scientific Validity (IVDR) | State of the art / clinical association | Scientific validity establishes the analyte-condition link; on the MDR side, the equivalent is the state-of-the-art review demonstrating the clinical claim. |
| Analytical performance | Analytical Performance (IVDR) | No MDR equivalent - | IVD-specific: sensitivity, specificity, trueness, precision, LoD, LoQ, linearity, cross-reactivity. MDR has no direct parallel. |
| Clinical performance | Clinical Performance (IVDR) | Clinical performance / benefit | Both describe the ability of the device to yield results correlated with a clinical condition or physiological state, in the target population and intended user's hands. |
| Pre-market study application | Performance Study Application (IVDR) | Clinical investigation application | Same EUDAMED-based Single Identification Number (SIN) route, 10-day validation, ~45-day substantive review, coordinated assessment procedure available. |
Section 4
Technical & metrological requirements
Requirements that live in Annex I but sit outside the clinical/performance track.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Metrological traceability | Metrological Traceability (IVDR) | Devices with a measuring function | IVDR requires a documented calibration hierarchy to higher-order reference materials or procedures. MDR Section 15 addresses metrological requirements for measuring devices but does not mandate the ISO 17511 traceability chain approach. |
| Risk management | IVDR Annex I Section 3 | ISO 14971 | Identical wording and the same harmonised standard (ISO 14971:2019 + A11:2021) covers both regulations. |
| Quality management system | IVDR Article 10(8) | ISO 13485 | Same standard, same certification, minor scope differences (design controls apply differently to Class A non-sterile IVDs vs Class I MDR devices). |
| UDI | IVDR Articles 24-30 | Unique Device Identification | One EUDAMED UDI database serves both regulations. IVD-specific Basic UDI-DI and UDI-DI attributes exist alongside the medical-device attribute set. |
Section 5
Post-market obligations
Surveillance, follow-up, transparency, and vigilance after CE marking.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Post-market surveillance plan | Post-Market Surveillance Plan (IVDR) | MDR PMS plan | Annex III is structurally identical across both regulations. Same expectations on proactive and reactive data sources and feedback into risk management. |
| Post-market follow-up study | Post-Market Performance Follow-Up (IVDR) | Post-Market Clinical Follow-up | Direct analogue. Both mandatory unless a documented, defensible justification for non-applicability exists. Both feed the periodic evidence report. |
| Periodic Safety Update Report | PSUR (IVDR Specific) | Periodic Safety Update Report | Class A/B IVDs and Class I MDR devices produce a PMS Report instead. Update cadence: annual for Class C/D IVDs and Class IIb/III MDR; every two years for Class IIa MDR. |
| Public safety summary | Summary of Safety and Performance (IVDR) | Summary of Safety and Clinical Performance | Both are notified-body-validated, publicly available via EUDAMED, and written for the intended user (and, where relevant, the patient). |
| Vigilance / incident reporting | IVDR Articles 82-83 | Medical Device Reporting (FDA) | Serious-incident reporting thresholds and timelines match: immediately for serious public-health threat, within 10 days for death/serious deterioration, within 15 days otherwise. |
| Transitional provisions | IVDR Transitional Provisions | MDR transitional provisions | Both extend legacy device availability subject to conditions (no significant changes, IVDR/MDR PMS and vigilance apply, written NB agreement by fixed milestones). |
Section 6
IVDR-only provisions
Concepts that have no meaningful MDR counterpart and are frequently missed by teams porting an MDR playbook.
| Concept | IVDR | MDR | Notes |
|---|---|---|---|
| Genetic testing (Article 4) | Genetic Testing Requirements (IVDR Article 4) | No MDR equivalent - | Member-State-level obligations on information, counselling, and consent. Produces the largest single source of national-level fragmentation in the IVDR. |
| EU Reference Laboratories | EU Reference Laboratory (EURL) | No MDR equivalent - | Designated laboratories that verify Class D device performance against CS. MDR has no analogue. |
| Self-test and near-patient testing | Self-Test and Near-Patient Testing (IVDR) | Usability engineering (IEC 62366-1) | Under MDR, lay-user usability is a general Annex I requirement. IVDR carves self-test and near-patient into named categories with dedicated classification rules and IFU expectations. |
How to read this crosswalk
- A match at row level does not mean the two provisions are interchangeable. Regulatory strategy, evidence requirements, and notified-body expectations are regulation-specific.
- Where an MDR column reads "No MDR equivalent", teams porting an MDR playbook to IVDR most often under-scope. Pay particular attention to Article 4 genetic testing, EU Reference Laboratory batch verification, and companion diagnostic EMA consultation.
- Article references are to the consolidated text on EUR-Lex; always confirm against the latest consolidated version because both regulations have been amended (Reg (EU) 2022/112, 2023/607, 2024/1860, and others).