--- title: "IVDR to MDR Crosswalk: Article-by-article Concept Mapping | MedTech Terms" description: "Vendor-neutral crosswalk between EU IVDR (2017/746) and EU MDR (2017/745): conformity assessment, performance evaluation, PMPF vs PMCF, SSP vs SSCP, and..." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "WebPage", "@id": "https://medtechterms.com/crosswalks/ivdr-mdr", "name": "IVDR-to-MDR Crosswalk", "description": "Article-by-article mapping between EU IVDR (2017/746) and EU MDR (2017/745) concepts: conformity assessment, performance evaluation, PMS, PMPF/PMCF, PSUR, SSP/SSCP, and IVDR-only provisions.", "url": "https://medtechterms.com/crosswalks/ivdr-mdr", "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" } }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Crosswalks", "item": "https://medtechterms.com/crosswalks/ivdr-mdr" }, { "@type": "ListItem", "position": 3, "name": "IVDR to MDR", "item": "https://medtechterms.com/crosswalks/ivdr-mdr" } ] }, { "@type": "Dataset", "name": "IVDR-to-MDR concept mapping", "description": "Structured mapping of IVDR provisions to their MDR equivalents with article references, notes on where the two regulations diverge, and links to primary sources.", "url": "https://medtechterms.com/crosswalks/ivdr-mdr", "creator": { "@type": "Person", "name": "Christian Espinosa" }, "publisher": { "@type": "Organization", "name": "MedTech Terms" }, "license": "https://creativecommons.org/licenses/by/4.0/" } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [Home](/) 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. [IVDR full text](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [MDR full text](https://eur-lex.europa.eu/eli/reg/2017/745/oj) [MDR vs IVDR overview](/compare/mdr-vs-ivdr) On this page - [1\. Foundations & scope](#g0) (4) - [2\. Conformity assessment](#g1) (6) - [3\. Clinical / performance evidence](#g2) (5) - [4\. Technical & metrological requirements](#g3) (4) - [5\. Post-market obligations](#g4) (6) - [6\. IVDR-only provisions](#g5) (3) 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](/terms/ivdr) [Regulation (EU) 2017/746 (IVDR)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [EU Medical Device Regulation](/terms/mdr) [Regulation (EU) 2017/745 (MDR)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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](/terms/ivdr-classes) [IVDR Annex VIII (Classes A, B, C, D)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) MDR device classes [MDR Annex VIII (Classes I, IIa, IIb, III)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-gspr) [IVDR Annex I](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [General Safety and Performance Requirements](/terms/gspr) [MDR Annex I](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-common-specifications) [IVDR Article 9](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Common Specifications [MDR Article 9](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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](/terms/ivdr-conformity-assessment-routes) [IVDR Articles 48-50, Annexes IX, X, XI](https://eur-lex.europa.eu/eli/reg/2017/746/oj) MDR conformity assessment [MDR Articles 52-54, Annexes IX, X, XI](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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 [IVDR Articles 31-46](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Notified Body](/terms/notified-body) [MDR Articles 35-50](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-notified-body-scrutiny) [IVDR Article 48(6), Article 106 (expert panels)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) CECP scrutiny [MDR Article 54, Article 106 (expert panels)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-companion-diagnostic) [IVDR Article 48(5), Annex IX Section 5.2 (EMA consultation)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 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)](/terms/ivdr-class-d-batch-verification) [IVDR Article 48(5), Article 100 (EU Reference Laboratories)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 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))](/terms/ivdr-in-house-devices) [IVDR Article 5(5)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Health-institution exemption [MDR Article 5(5)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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](/terms/ivdr-performance-evaluation) [IVDR Article 56, Annex XIII](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Clinical Evaluation Plan](/terms/clinical-evaluation-plan) [MDR Article 61, Annex XIV](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-scientific-validity) [IVDR Annex XIII Section 1.2.1](https://eur-lex.europa.eu/eli/reg/2017/746/oj) State of the art / clinical association [MDR Annex XIV Part A](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-analytical-performance) [IVDR Annex I Section 9.1(a), Annex XIII Section 1.2.2](https://eur-lex.europa.eu/eli/reg/2017/746/oj) No MDR equivalent \- IVD-specific: sensitivity, specificity, trueness, precision, LoD, LoQ, linearity, cross-reactivity. MDR has no direct parallel. Clinical performance [Clinical Performance (IVDR)](/terms/ivdr-clinical-performance) [IVDR Annex XIII Section 1.2.3](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Clinical performance / benefit [MDR Annex I Section 1, Annex XIV](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-performance-study-application) [IVDR Articles 58, 66, Annex XIV](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Clinical investigation application [MDR Articles 70, 74, Annex XV](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-metrological-traceability) [IVDR Annex I Section 9.4, ISO 17511:2020](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Devices with a measuring function [MDR Annex I Section 15](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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 [IVDR Annex I Section 3, ISO 14971](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [ISO 14971](/terms/iso-14971) [MDR Annex I Section 3, ISO 14971](https://eur-lex.europa.eu/eli/reg/2017/745/oj) Identical wording and the same harmonised standard (ISO 14971:2019 + A11:2021) covers both regulations. Quality management system IVDR Article 10(8) [IVDR Article 10(8), ISO 13485](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [ISO 13485](/terms/iso-13485) [MDR Article 10(9), ISO 13485](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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 [IVDR Articles 24-30](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Unique Device Identification](/terms/udi) [MDR Articles 27-33](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-pms-plan) [IVDR Article 79, Annex III](https://eur-lex.europa.eu/eli/reg/2017/746/oj) MDR PMS plan [MDR Article 84, Annex III](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-pmpf) [IVDR Annex XIII Part B (PMPF)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Post-Market Clinical Follow-up](/terms/pmcf) [MDR Annex XIV Part B (PMCF)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/psur-ivdr) [IVDR Article 81 (Class C and D)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Periodic Safety Update Report](/terms/psur) [MDR Article 86 (Class IIa, IIb, III)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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)](/terms/ivdr-summary-safety-performance) [IVDR Article 29 (SSP, Class C and D)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Summary of Safety and Clinical Performance](/terms/sscp) [MDR Article 32 (SSCP, implantable and Class III)](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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 [IVDR Articles 82-83](https://eur-lex.europa.eu/eli/reg/2017/746/oj) [Medical Device Reporting (FDA)](/terms/mdr-reporting) [MDR Articles 87-88](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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](/terms/ivdr-transitional-provisions) [IVDR Article 110 as amended by Reg (EU) 2024/1860](https://eur-lex.europa.eu/eli/reg/2024/1860/oj) MDR transitional provisions [MDR Article 120 as amended by Reg (EU) 2023/607](https://eur-lex.europa.eu/eli/reg/2023/607/oj) 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)](/terms/ivdr-genetic-testing) [IVDR Article 4](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 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)](/terms/ivdr-eu-reference-laboratory) [IVDR Articles 100, 48(5)](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 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)](/terms/ivdr-self-test) [IVDR Article 2(5)-(6), Annex I Section 19](https://eur-lex.europa.eu/eli/reg/2017/746/oj) Usability engineering (IEC 62366-1) [MDR Annex I Section 5, IEC 62366-1](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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). ## Related resources [MDR vs IVDR side-by-side comparison](/compare/mdr-vs-ivdr) [IVDR Essentials learning path](/paths/ivdr-essentials) [All Regulatory terms](/categories/regulatory) [Sourcing and review methodology](/methodology) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)