Strategic
Agenda
2024 - 2029
The European Union was founded on
the imperative of securing peace in
Europe, building on cooperation,
solidarity and common economic
prosperity. This original p
01.12.2025
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1
Smart Contracting
Platform
Effizienz durch Automatisierung – Next Step: AI?
SkalierbarkeitRisikominimierungAutomatisierung Effizienz
(digital representation
of the contracts)
Insurer
01.12.2025
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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
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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
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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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▪
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▪
▪
▪
▪
Folie 1
01.12.2025
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Maßgeblich ist allein der Inhalt des Referentenentwurfs; die Synopse dient lediglich als Arbeitshilfe.
01.12.2025
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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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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
