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Berlin
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10117 Berlin
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bah@bah-bonn.d
21.05.2024
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PD
Safe and Sustainable by Design
chemicals and materials
Application of the SSbD
framework to case studies
DRAFT FOR CONSULTATION
Caldeira, C., Garmendia Aguirre, I., Tosches, D.,
Farcal, R.,
21.05.2024
Datei
PD
Questions and Answers on Trend reporting as outlined in the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Introducti
21.05.2024
Datei
PD
Sheet1
Section Help text, concentrate on the trend report specific issues, those fields which are identical with the MIR will be according to the updated MIR and will be adjusted in the EUDAMED web
21.05.2024
Datei
PD
Kombinationsprodukte: Eine Einführung
Donnerstag, den 23. Februar 2023
Philipp Doebert
M.Sc. Student – Drug Device Combinations
Betreuer:
Dr. Heike Wollersen & Marie Anton
1
Agenda
1. Kombin
21.05.2024
Datei
PD
1
Kombinationsprodukte.
Abgrenzung & Herausforderungen
aus Sicht der Industrie.
Alexandra Federer, MDRA
Senior Regulatory Affairs Manager, DACH
Informationsbeauftragte §74a, AMG
GlaxoSmithKline
21.05.2024
Datei
PD
Template for comments
Date:
Trend report Q&A document
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Type of comment2
Comments
Proposed change
Task force comment3
MPA
21.05.2024
Datei
PD
Arzneimittel-Medizinprodukte-
Kombinationsprodukte, ein Update
Drug Device combination products:
overview & current challenges
23/02/2023| 2
© Copyright CE plus, a division of regenold GmbH | F
21.05.2024
Datei
PD
Taul1
Section Help text, concentrate on the trend report specific issues, those fields which are identical with the MIR will be according to the updated MIR and the structure of the form will be adj
21.05.2024
Datei
PD
