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mdcg_2024-4_en.pdf
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
mdcg_2024-5_en.pdf
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
mdcg_2023-5_en.pdf
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
MDCG_2023-7_Guidance_on_exemptions_from_the_requirement_to_perform_clinical_investigations_pursuant_to_Article_61_4_-_6__MDR_and.pdf
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
MDCG_2024-1-5_Guidance_on_the_vigilance_system_for_CE-marked_devices_DSVG_05_Urogynaecological_Surgical_Mesh_Implants_used_for_Pelvic_Organ_Prolapse_repair_and_Stress_Urinary_Incontinence.pdf
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
mdcg_2022-11_en.pdf
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
mdcg_2023-6_en.pdf
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
KW_32_WB.pdf
Pharmakovigilanz-Wochenbericht KW 32/2024 12. August 2024 _____________________________________ 1 Neuigkeiten aus dem Bereich Pharmakovigilanz 1. EMA: Aktuelle PRAC-Empfehlung
08.12.2025 Datei PD
KW_48_WB.pdf
Pharmakovigilanz-Wochenbericht KW 48/2023 04. Dezember 2023 _____________________________________ 1 Neuigkeiten aus dem Bereich Pharmakovigilanz 1. EMA: Agenda und Meeting Highli
08.12.2025 Datei PD
KW_33_WB.pdf
Pharmakovigilanz-Wochenbericht KW 33/2024 19. August 2024 _____________________________________ 1 Neuigkeiten aus dem Bereich Pharmakovigilanz 1. EMA: Upgrade der Homepage
08.12.2025 Datei PD
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