TÜV NORD CERT GmbH
Am TÜV 1, 45307 Essen
www.tuev-nord-cert.com
TÜV®
Certificate
Management system as per
DIN EN ISO 9001:2015
The Certification Body TÜV NORD CERT Gm
01.12.2025
Datei
PD
Template for comments
MDCG IVD WG
MDCG CIE WG
Document: Questions and Answers regarding performance studies
Distributed to regulators and stakeholders of the MDCG IVD and CIE WGs
Consultation dead
01.12.2025
Datei
PD
Template for comments
Date:
Document:
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Paragraph/
Figure/Table
Type of comment2
Comments
Proposed change
Subgroup comment3
01.12.2025
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PD
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▪
▪
▪
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Folie 1
01.12.2025
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PD
Maßgeblich ist allein der Inhalt des Referentenentwurfs; die Synopse dient lediglich als Arbeitshilfe.
01.12.2025
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2023-3 Rev. 1
Page 1 of 24
1
2
3
4
MDCG 2023-3 Rev. 1 5
Questions and Answers on vigilance terms 6
and concepts a
01.12.2025
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PD
Medical Devices
Medical Device Coordination Group Document MDCG 2023-3
Page 1 of 23
1
2
3
4
MDCG 2023-3 Rev. 1 5
Questions and Answers on vigilance terms 6
and concepts as out
01.12.2025
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PD
Template for comments Date: 15 September 2023
Document: Q&A on vigilance terms
and concepts under MDR and IVDR
(MDCG 2023-3)
Project: Consultation_PMSV
WG and IVD WG
NCA /
Stakeh
o
01.12.2025
Datei
PD
GRADUAL ROLL-OUT OF EUDAMED
Q&A on practical aspects related to the implementation of the gradual roll-
out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation
(EU) 2024/1860 amen
01.12.2025
Datei
PD
