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mdcg_2024-10_en.pdf
Medical Devices Medical Device Coordination Group Document MDCG 2024-10 1 MDCG 2024-10 Clinical evaluation of orphan medical devices June 202
30.03.2026 Datei PD
mdcg_2024-3_en_0.pdf
Medical Device Medical Device Coordination Group Document MDCG 2024-3 1 MDCG 2024-3 Guidance on content of the Clinical Inve
30.03.2026 Datei PD
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
30.03.2026 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
30.03.2026 Datei PD
mdcg_2024-12_en.pdf
Medical Device Coordination Group Document MDCG 2024-12 applicable for  M
30.03.2026 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
30.03.2026 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
30.03.2026 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
30.03.2026 Datei PD
mdcg_ongoing-guidance.pdf
1 Ongoing guidance development and deliverables of MDCG Subgroups – March 2023* *This is not an exhaustive list of ongoing work performed by MDCG Subgroups Scope Group Deliverables Consult
30.03.2026 Datei PD
list-european-union-reference-dates-frequency-submission-periodic-safety-update-reports-psurs_en.xlsx
EU reference dates list The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the following principles apply: - A sla
30.03.2026 Datei PD
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