Medical Device
Medical Device Coordination Group Document MDCG 2024-5
MDCG 2024-5
guidance on content of the Investigator’s Brochure for
clinical in
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-4
Page 1 of 23
MDCG 2024-4
Safety reporting in performance studies of in vitro
diagnostic medical de
08.12.2025
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Medical Device
Medical Device Coordination Group Document MDCG 2024-3
1
MDCG 2024-3
Guidance on content of the Clinical
Inve
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-5
MDCG 2024-1-5
Guidance on the vigilance system
for CE-marked devices
DSVG
08.12.2025
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Medical Device
Medical Device Coordination Group Document MDCG 2023-7
1(12)
MDCG 2023-7
Guidance on exemptions from the requirement to
perfor
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-6
Page 1 of 4
MDCG 2023-6
Guidance on demonstration of
equivalence for Annex XVI products
A guide
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-5
Page 1 of 14
MDCG 2023-5
Guidance on qualification and classification of Annex XVI
products
A guide
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2022-11 Rev.1
Page 1 of 7
MDCG 2022-11 Rev.1
MDCG Position Paper
Notice to manufacturers and notifi
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2022-9 Rev.1
Page 1 of 9
This document has been endorsed by the Medical Device
08.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2022 – 5 Rev. 1
Page 1 of 28
MDCG 2022 – 5 Rev. 1
Guidance on borderline between medical
devices and me
08.12.2025
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