1
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki procedure 2021
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Confidential between Member States
Prob
01.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-3
Page 1 of 6
MDCG 2024-1-3
Guidance on the vigilance system
for CE-marked dev
01.12.2025
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Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-2
MDCG 2024-1-2
Guidance on the vigilance system
for CE-marked devices
DSV
01.12.2025
Datei
PD
Medical Devices
Medical Device Coordination Group Document MDCG 2024-1-4
MDCG 2024-1-4
Guidance on the vigilance system
for CE-marked devices
DSVG
01.12.2025
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Guidance on the implementation of the Master UDI-DI solution for contact lenses
Contents
Introduction and scope 3
1. Terminology 4
2. The Master UDI-DI 5
3. Labelling 7
4. Rules on Master UDI-DI ass
01.12.2025
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Medical Device
Medical Device Coordination Group Document MDCG 2024-3
Appendix A: Clinical Investigation Plan Synopsis Template
Clinical Investigation Synopsis (Tem
01.12.2025
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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)
01.12.2025
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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
2
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
01.12.2025
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