Medical Devices
Medical Device Coordination Group Document MDCG 2022 – 5 Rev. 1
Page 1 of 28
MDCG 2022 – 5 Rev. 1
Guidance on borderline between medical
devices and me
20.09.2024
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2022 – 5 Rev. 1
Page 1 of 28
MDCG 2022 – 5 Rev. 1
Guidance on borderline between medical
devices and me
20.09.2024
Datei
PD
Consolidated comments on MDCG 2024-xx (draft 24.7.2024)
Date: 10.9.2024
Document: draft position paper
MDCG 2024-xx (draft 24.7.2024)
Project lead: MDCG B&C WG
Stake-
holder
Lin
20.09.2024
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2024-XX
REVISED DRAFT (190.9.2024) 1
2
3
4
5
MDCG 2024-XX 6
7
R
20.09.2024
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-XX
MDCG 2024-XX
Regulatory status of ethylene oxide
20.09.2024
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PD
Ausgabe 87/2024
19. September 2024
Persönliches Exemplar für Pharma Deutschland Presse
Inhaltsverzeichnis
Pressemitteilung
Pharma Deutschland fordert schnelle Reform der
Medizinprodukte-Regulierun
19.09.2024
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PD
Template for comments
Date:
Document:
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Paragraph/
Figure/Table
Type of comment2
Comments
Proposed change
Subgroup comment3
19.09.2024
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1
First set of updated/additional questions proposed for 1
Revision n.5 of MDCG 2019-6 – Part B (Structured dialogue) 2
3
Revision table 4
MDCG 2019-6 revision 5 changes
I.5. Previous
19.09.2024
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1
First set of updated/additional questions proposed for 2
Revision n.5 of MDCG 2019-6 – Part A 3
4
Q&A IV.1 is proposed to be updated as follows 5
6
IV.1. Do devices certified under the
19.09.2024
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Ausgabe 86/2024
18. September 2024
Persönliches Exemplar für Pharma Deutschland Presse
Inhaltsverzeichnis
Arzneimittelzulassung
EMA/HMA Multi-Stakeholder Workshop zur
Vorhersagbarkeit von Einreich
18.09.2024
Datei
PD
