EU Medical Devices Regulation (MDR 2017/745)
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.120: Transitional provisions (Article 120 as amended by (EU) 2023/607)

Article 120 as amended by (EU) 2023/607 sets the transitional periods for legacy MDs (devices already on the market under Directives 90/385/EEC or 93/42/EEC before 26 May 2021). Class III implantables + Class IIb implantables (with exceptions): legacy devices may continue under specified conditions until 31 December 2027. Other Class IIb + Class IIa + Class I sterile/measuring: until 31 December 2028. Conditions: existing MDD/AIMDD certificate + ongoing PMS + no significant change in design/intended purpose + Article 120(3a) notification to MSA of intention to rely on the extension. CRA-Art.11 carve-out: MD cybersecurity remains under MDR; CRA does not apply.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • CRA-Art.11_12 Relationship with general product safety and AI Act (Articles 11-12)
  • IVDR-Art.110 Transitional provisions (Article 110 as amended by (EU) 2024/1860)

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

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