Template for comments
MDCG CIE WG
WP23
Document: updated MDCG 2019-9 SSCP
Distributed to CIE stakeholders
Consultation deadline 15 March 2024
Version 2.1
Date: 2024-10-21
Page 1(16)
NCA1
01.12.2025
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Reporting form
MDCG 2024-4 Performance Study Summary Safety Report Form v1.0
EUDAMED/CIV-ID
Title of Performance Study
PSP number/code
Contact person
(name, address,
e-mail, telephone number)
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Medical Device
Medical Device Coordination Group Document MDCG 2024-XX
page 1 of 96
Restricted Information and Basic Personal Data
1
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3
4
5
6
7
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Blad1
chapter NCA1 CIE / DA NBOG/ COM / Other Line number / reference Type of comment2 Comment Proposed change Subgroup comment3
intro aesgp 73 te Sentence is incomplete Change “placing a safe med
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DE DE
EUROPÄISCHE
KOMMISSION
Brüssel, den XXX
[…](2024) XXX draft
DURCHFÜHRUNGSBESCHLUSS DER KOMMISSION
vom XXX
zur Änderung des Durchführungsbeschlusses C(2021) 2406 über ei
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DE DE
EUROPÄISCHE
KOMMISSION
Brüssel, den XXX
[…](2024) XXX draft
DURCHFÜHRUNGSBESCHLUSS DER KOMMISSION
vom XXX
zur Änderung des Durchführungsbeschlusses C(2021) 2406 über ei
01.12.2025
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EN EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2024) XXX draft
COMMISSION IMPLEMENTING DECISION
of XXX
amending Implementing Decision C(2021) 2406 on a standardisation request t
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- 1 -
Draft 3008.04.2024
(after workshop of 25.4.2024)
(changes introduced following the workshop on 25.4. are highlighted in green)
EXTENSION OF THE MDR 1
2
3
4
5
EXTENSION OF
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Medical Devices
Medical Device Coordination Group Document MDCG 2024- xxMDCG 2024-XX
Guidance on post-market surveillance of medical devices and in vitro diagnostic
01.12.2025
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1
2
3
MDCG 2021-12 rev.1 4
5
FAQ on the European Medical Device 6
Nomenclature (EMDN) 7
8
May 2021 9
10
11
This document has been endorsed by the Medical Device Coordi
01.12.2025
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