EU MDR CE marking stories
Case Studies - MDR CE Marking
Walk through real EU MDR CE marking projects delivered by I3CGlobal, slide by slide. Select a device to see how it reached CE certification.
7Case studies
2022–25Project years
Case study 01 of 07
⛶ Full screenInsulin Pump
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- Device Class
- Class III
- Project Tenure
- Sep 2023 – Nov 2024
Case study 02 of 07
⛶ Full screenInfant Warmer
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- Device Class
- Class IIb
- Project Tenure
- Apr 2024 – Feb 2025
Case study 03 of 07
⛶ Full screenDefibrillator
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- Device Class
- Class III
- Project Tenure
- Dec 2023 – Nov 2025
Case study 04 of 07
⛶ Full screenPhototherapy
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- Device Class
- Class IIb
- Project Tenure
- Jan 2024 – Nov 2025
Case study 05 of 07
⛶ Full screenIntrauterine Device
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- Device Class
- Class III, Rule 14
- Project Tenure
- Jun 2023 – Nov 2024
Case study 06 of 07
⛶ Full screenMedical Device Software (MDSW)
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- Device Class
- Class IIa, Rule 11
- Project Tenure
- Sep 2022 – Mar 2024
Case study 07 of 07
⛶ Full screenDenture Material
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- Device Class
- Class IIa
- Project Tenure
- Feb 2024 – Jun 2025
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