--- title: "EU MDR vs EU IVDR - side-by-side comparison | MedTech Terms" description: "Regulation (EU) 2017/745 vs Regulation (EU) 2017/746" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "WebPage", "@id": "https://medtechterms.com/compare/mdr-vs-ivdr", "name": "EU MDR vs EU IVDR - MedTech Terms", "description": "Regulation (EU) 2017/745 vs Regulation (EU) 2017/746", "url": "https://medtechterms.com/compare/mdr-vs-ivdr", "about": [ { "@type": "DefinedTerm", "name": "EU Medical Device Regulation", "url": "https://medtechterms.com/terms/mdr" }, { "@type": "DefinedTerm", "name": "EU In Vitro Diagnostic Regulation", "url": "https://medtechterms.com/terms/ivdr" } ], "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": "Compare", "item": "https://medtechterms.com/compare" }, { "@type": "ListItem", "position": 3, "name": "EU MDR vs EU IVDR", "item": "https://medtechterms.com/compare/mdr-vs-ivdr" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/compare/mdr-vs-ivdr#faq", "mainEntity": [ { "@type": "Question", "name": "Can one product need both MDR and IVDR CE marks?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, when a system combines an IVD component (specimen analysis) with a non-IVD medical device (a therapy or monitoring function). Each component is assessed under its own regulation, often placed on market as an integrated combination with two conformity assessment paths." } }, { "@type": "Question", "name": "Do MDR and IVDR use the same Notified Bodies?", "acceptedAnswer": { "@type": "Answer", "text": "Not automatically. A Notified Body must be separately designated under MDR and under IVDR, with distinct scope codes for each device category. Many bodies hold both designations, but scope must be checked in NANDO before submission." } }, { "@type": "Question", "name": "How do the extended transition periods affect legacy devices?", "acceptedAnswer": { "@type": "Answer", "text": "Regulations (EU) 2023/607 (MDR) and 2024/1860 (IVDR) extended sell-off and transition dates so legacy directive-certified devices can remain on the market under conditions: an active QMS, application filed with a Notified Body by defined dates, and no significant changes to design or intended purpose." } }, { "@type": "Question", "name": "What is the difference between MDR and the MDD?", "acceptedAnswer": { "@type": "Answer", "text": "MDR (Regulation (EU) 2017/745) replaced the Medical Devices Directive (93/42/EEC) in 2021. Key changes: stricter clinical evidence, mandatory UDI and EUDAMED registration, reclassification of many devices (especially software under Rule 11), lifecycle post-market surveillance, and a PRRC role." } }, { "@type": "Question", "name": "What is Rule 11 under EU MDR?", "acceptedAnswer": { "@type": "Answer", "text": "Rule 11 classifies software intended to provide information used for decisions with diagnostic or therapeutic purposes. Most such software is Class IIa or higher, with Class III applied when decisions may cause death or irreversible deterioration." } }, { "@type": "Question", "name": "What are the MDR transition deadlines?", "acceptedAnswer": { "@type": "Answer", "text": "Regulation (EU) 2023/607 extended MDD certificates: Class III and implantable Class IIb through 31 December 2027, and Class IIa, Class IIb non-implantable, and Class I devices requiring Notified Body involvement through 31 December 2028, provided manufacturers have applied to a Notified Body by set deadlines and meet other conditions." } }, { "@type": "Question", "name": "Do I need a Notified Body under MDR?", "acceptedAnswer": { "@type": "Answer", "text": "Yes for every device above Class I. Class I sterile, measuring, and reusable surgical devices also require Notified Body involvement (for the sterility, metrology, or reprocessing aspects respectively)." } }, { "@type": "Question", "name": "How is IVDR classification different from MDR?", "acceptedAnswer": { "@type": "Answer", "text": "IVDR uses Rules 1-7 (Annex VIII) based on intended purpose and risk to individual and public health. Class D is the highest risk (transmissible agents, blood grouping) and requires EU Reference Laboratory batch testing plus common specifications." } }, { "@type": "Question", "name": "When did IVDR apply?", "acceptedAnswer": { "@type": "Answer", "text": "Date of application was 26 May 2022. Regulation (EU) 2022/112 and 2024/1860 extended transition periods for legacy IVDD devices through 2027 (Class D) and 2029 (Class B and A sterile), provided conditions are met." } }, { "@type": "Question", "name": "Is a Notified Body required for every IVD?", "acceptedAnswer": { "@type": "Answer", "text": "No. Class A non-sterile IVDs are self-declared. All other classes (A sterile, B, C, D) require Notified Body conformity assessment." } }, { "@type": "Question", "name": "What is an in-house test under Article 5(5)?", "acceptedAnswer": { "@type": "Answer", "text": "An IVD manufactured and used only within a single EU health institution for its own patients. It must not be industrially manufactured, must meet Annex I general safety and performance requirements, and requires justification that no CE-marked equivalent exists on the market." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All comparisons](/compare) Compare # EU MDR vs EU IVDR Regulation (EU) 2017/745 vs Regulation (EU) 2017/746 MDR and IVDR are the two EU regulations that replaced the older MDD, AIMDD, and IVDD directives. MDR covers general medical devices; IVDR covers in vitro diagnostics. They share structure and vocabulary (CE marking, Notified Bodies, EUDAMED, PMS, PMCF and PMPF) but classify devices, define clinical evidence, and set transition timelines very differently. Attribute Regulatory [EU Medical Device Regulation(MDR) ](/terms/mdr) Regulatory [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) Formal name Regulation (EU) 2017/745 on medical devices (MDR) Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Scope General medical devices, active implantables, software as a medical device (non-diagnostic) In vitro diagnostic devices: reagents, instruments, software analyzing specimens outside the body Date of application May 26, 2021 May 26, 2022 Extended transition (as amended) Legacy MDD / AIMDD devices: up to Dec 31, 2027 (Class III / implantables) or Dec 31, 2028 (Class IIa, IIb, Is, Im, Ir) per Regulation (EU) 2023/607 Legacy IVDD devices: up to Dec 31, 2027 (Class D), Dec 31, 2028 (Class C), Dec 31, 2029 (Class B and A sterile) per Regulation (EU) 2024/1860 Classification system 4 classes: I, IIa, IIb, III, driven by Annex VIII (22 rules) 4 classes: A (lowest) to D (highest), driven by Annex VIII (7 rules) Notified Body involvement Required for Class IIa, IIb, III, and Class I sterile / measuring / reusable surgical Required for Class B, C, and D (up from around 8% of IVDs under IVDD to around 85% under IVDR) Clinical evidence document Clinical Evaluation Report (CER) with clinical investigation data or literature-based justification Performance Evaluation Report (PER) covering scientific validity, analytical performance, clinical performance Post-market follow-up PMCF (Post-Market Clinical Follow-up) plan and report PMPF (Post-Market Performance Follow-up) plan and report Periodic safety report PSUR required for Class IIa, IIb, and III PSUR required for Class C and D; Class B requires a PSR Reference laboratories Not applicable EU Reference Laboratories (EURLs) verify performance of Class D IVDs before market UDI database Uploaded to EUDAMED UDI / Device module Uploaded to EUDAMED UDI / Device module with IVD-specific data elements Companion diagnostic handling Non-CDx software or devices remain under MDR Companion diagnostics (CDx) explicitly regulated as Class C under IVDR Annex VIII Rule 3(h) Common misuse Assuming MDR covers a device that has an IVD component (assay software often falls under IVDR) Underestimating Notified Body involvement, most IVDs that were self-certified under IVDD now need a NB ## When to use which Choose MDR Use MDR when the device acts on or in the human body directly (implants, surgical instruments, imaging systems, monitoring software that is not diagnostic). Software that provides information for diagnostic or therapeutic purposes but does not analyze specimens is usually MDR (Rule 11 often applies). [Full MDR page](/terms/mdr) Choose IVDR Use IVDR when the device is intended to examine specimens (blood, tissue, saliva, urine) taken from the body to provide information on physiological state, disease, or predisposition. Companion diagnostics used to select patients for a therapy fall under IVDR. [Full IVDR page](/terms/ivdr) ## Frequently asked questions Can one product need both MDR and IVDR CE marks? Yes, when a system combines an [IVD](/terms/ivd) component (specimen analysis) with a non-IVD medical device (a therapy or monitoring function). Each component is assessed under its own regulation, often placed on market as an integrated combination with two conformity assessment paths. Do MDR and IVDR use the same Notified Bodies? How do the extended transition periods affect legacy devices? What is the difference between MDR and the MDD? What is Rule 11 under EU MDR? What are the MDR transition deadlines? Do I need a Notified Body under MDR? How is IVDR classification different from MDR? When did IVDR apply? Is a Notified Body required for every IVD? What is an in-house test under Article 5(5)? Comparison built from the sourced definitions and FAQs on the linked term pages. MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice. MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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