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Medical Device 3
Medical Device Coordination Group Document MDCG 2019-11 4
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MDCG 2019-11_rev2 10
Guidance on Qualification and Classification
01.12.2025
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FR FR
COMMISSION
EUROPÉENNE
Bruxelles, le XXX
[…](2024) XXX draft
DÉCISION D’EXÉCUTION DE LA COMMISSION
du XXX
modifiant la décision d’exécution C(2021) 2406 relative à une d
01.12.2025
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PD
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
01.12.2025
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The European Association of
Medical devices Notified Bodies
Team-NB Position Paper
TEAM-NB Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions.docx Page 1/13
Editor
01.12.2025
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PD
MDCG New Technologies WG – interplay between MDR/IVDR and the 1
EU Artificial Intelligence Act (AIA) 2
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This document aims to reflect questions raised during the New Technologies WG workshop on
01.12.2025
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ABHS N 764
SNAPSHOT
Medical Devices – List of European Standards intended to be cited
in the Official Journal of the European Union (OJEU) under the
Directives:
• on Medical De
01.12.2025
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PD
Medical Device
Medical Device Coordination Group Document MDCG 2024-XX
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MDCG 2024-XX 6
Guidance on the legal status of 7
medical device sof
01.12.2025
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JICF survey on the HERA Stakeholders' HUB
Fields marked with * are mandatory.
The project is initiated in response to the “Communication on addressing medicine shortages in the EU” (Ref. COM(2023)
01.12.2025
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PD
Template for comments
Project: CIE WP 22
Document: draft MDCG clinical evaluation
Date: 26 July 2024
Page 1(1)
NCA1 CIE / DA NBOG/ COM / Other
Line number / reference
Type of comment2
01.12.2025
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PD
Medical Device
Medical Device Coordination Group Document MDCG 2019-9 Rev.21
MDCG 2019-9 Rev.21
Summary of safety and clinical performance
A guide for manufacturers and
01.12.2025
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PD
