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    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.

    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
    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

    Frequently asked questions

    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.
    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.