Bearbeitungsstand: 14.06.2024 13:06
Referentenentwurf
des Bundesministeriums für Gesundheit
Entwurf eines Gesetzes zur Stärkung der Herzgesundheit (Gesundes-
Herz-Gesetz – GHG)
A. Problem
01.12.2025
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PD
- 1 -
Draft September 2024
PEXTENSION OF THE MDR 1
2
3
4
5
THE INFORMATION OBLIGATION IN CASE OF INTERRUPTION OR 6
DISCONTINUTION OF SUPPLY OF CERTAIN MEDICAL DEVICES AND I
01.12.2025
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PD
MDCG 2024-XX
Guidance on the implementation of
the Master UDI-DI solution for
contact lenses
XX 2024 Draft 3.1_Rev. 30-8-2024
This document has been endorsed
01.12.2025
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PD
MDCG 2024-XX
Guidance on the implementation of
the Master UDI-DI solution for
contact lenses
XX 2024 Draft 3.1_Rev. 30-8-2024
This document has been endorsed
01.12.2025
Datei
PD
The European Association of
Medical devices Notified Bodies
Team-NB Position Paper
TEAM-NB Team-NB-PositionPaper-IVD-Transfer-Agreement-20240911.docx Page 1/12
Editor : T
01.12.2025
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PD
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
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PD
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
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PD
EN 1 EN
COMMISSION IMPLEMENTING DECISION (EU) …/…
of XXX
amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard
for aseptic processing of health care products
(Tex
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PD
EN 1 EN
COMMISSION IMPLEMENTING DECISION (EU) …/…
of XXX
amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for
aseptic processing of health care products and clini
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PD
Template for comments
Date:
Document: Q&A Art10a
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Paragraph/
Figure/Table
Type of comment2
Comments
Proposed change
Commissio
01.12.2025
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PD
