Eine Multi-Stakeholder-Strategie
Koordiniert vom Berlin Institute of Health at Charité
Im Auftrag des Bundesministeriums für Bildung und Forschung
Nationale Strategie für
gen- und zellbasierte Thera
08.12.2025
Datei
PD
Medical Devices
Medical Device Coordination Group Document MDCG 2024-10
1
MDCG 2024-10
Clinical evaluation of orphan
medical devices
June 202
08.12.2025
Datei
PD
Medical Device
Medical Device Coordination Group Document MDCG 2024-3
1
MDCG 2024-3
Guidance on content of the Clinical
Inve
08.12.2025
Datei
PD
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
Datei
PD
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
Datei
PD
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
Datei
PD
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
Datei
PD
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
Datei
PD
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
Datei
PD
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
Datei
PD
