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    EU Medical Device Regulation

    Regulation (EU) 2017/745 governing medical devices in the European Union.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Regulation (EU) 2017/745 (MDR) lays down rules concerning the placing on the market, making available, and putting into service of medical devices for human use and accessories, replacing the previous Medical Devices Directive (MDD).

    What this means in practice

    MDR introduces stricter clinical evidence requirements, stronger post-market surveillance, UDI, EUDAMED registration, and an enhanced role for Notified Bodies. Many devices have undergone reclassification, especially software.

    Use cases

    1 scenario
    1

    Class IIb device transitioning from MDD to EU MDR

    Regulatory & Clinical

    The manufacturer expands clinical evaluation, refreshes the technical file to MDR Annex II/III, signs a notified body contract, and registers the device and economic operators in EUDAMED.

    OutcomeCE marking under MDR is issued before the legacy MDD certificate expires, avoiding a supply gap.

    Cross-references

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1RAPS·1FDA·1
    1. 1
      Regulation (EU) 2017/745
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.