1
First set of updated/additional questions proposed for 2
Revision n.5 of MDCG 2019-6 – Part A 3
4
Q&A IV.1 is proposed to be updated as follows 5
6
IV.1. Do devices certified under the
01.12.2025
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EN 1 EN
COMMISSION IMPLEMENTING DECISION (EU) …/…
of XXX
amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard
for aseptic processing of health care products
(Tex
01.12.2025
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EN 1 EN
COMMISSION IMPLEMENTING DECISION (EU) …/…
of XXX
amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for
aseptic processing of health care products and clini
01.12.2025
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PD
Template for comments
Date:
Document: Q&A Art10a
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Paragraph/
Figure/Table
Type of comment2
Comments
Proposed change
Commissio
01.12.2025
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1
2
Medical Device 3
Medical Device Coordination Group Document MDCG 2019-11 4
5
6
7
8
9
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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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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MDCG New Technologies WG – interplay between MDR/IVDR and the 1
EU Artificial Intelligence Act (AIA) 2
3
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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