Reporting Feedback on EUDAMED Playground, v3.3.0 Q4 2022
REPORTING FEEDBACK FORM
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21.05.2024
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-3
Page 1 of 18
MDCG 2023-3
Questions and Answers on vigilance terms
and concepts as outlined in the Regul
21.05.2024
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Medical Devices
Medical Device Coordination Group Document MDCG 2021-5 Rev. 1
MDCG 2021-5 Rev. 1
Guidance on standardisation for medical devices
April 202
21.05.2024
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-1
Page 1 of 20
MDCG 2023-1
Guidance on the health institution
exemption under Article 5(5) of
Regulatio
21.05.2024
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Pharmakovigilanz-Wochenbericht
KW 09/2023
06. März 2023
_____________________________________
1
Neuigkeiten aus dem Bereich Pharmakovigilanz
1. EMA:
Aktuelle PRAC-Empfehlun
21.05.2024
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Preliminary assessment review template[footnoteRef:1]- MDR (Regulation (EU) 2017/745) [1: This form will be used to document the review of the CAB´s application by the DA. This document might be used
21.05.2024
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Preliminary assessment review template[footnoteRef:1]- IVDR (Regulation (EU) 2017/746) [1: This form will be used to document the review of the CAB´s application by the DA. This document might be use
21.05.2024
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Final
List of Standard Fees
Introduction
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of Regulation (EU) 2017/746 on in
vitro diagnostic medical devices
21.05.2024
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Medical Devices
Medical Device Coordination Group Document MDCG 2023-2
MDCG 2023-2
List of standard fees
January 2023
This documen
21.05.2024
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Pharmakovigilanz - Wochenbericht
- KW 10/2023 -
1
Stand 13.03.2023
Alle Angaben ohne Gewähr!
Screening Pharmakovigilanz-relevanter Webseiten
- Dokumentation -
EMA: What's New?
E
21.05.2024
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