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
Template for comments Date: 15 September 2023
Document: Q&A on vigilance terms
and concepts under MDR and IVDR
(MDCG 2023-3)
Project: Consultation_PMSV
WG and IVD WG
NCA /
Stakeh
o
01.12.2025
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GRADUAL ROLL-OUT OF EUDAMED
Q&A on practical aspects related to the implementation of the gradual roll-
out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation
(EU) 2024/1860 amen
01.12.2025
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- 1 -
Draft August 2024
PEXTENSION OF THE MDR 1
2
3
4
5
THE INFORMATION OBLIGATION IN CASE OF INTERRUPTION OR 6
DISCONTINUTION OF SUPPLY OF CERTAIN MEDICAL DEVICES AND IN 7
01.12.2025
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1
SUMMARY OF ENQUIRY
TO MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki Procedure 2021
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
Confidential between Member States
01.12.2025
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ABHS N 773
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
Reporting Feedback on EUDAMED Playground, v3.9.0 July 2024
REPORTING FEEDBACK FORM
This is a Reporting Feedback Form provided to EUDAMED Stakeholders and CAs to report their testing following the la
01.12.2025
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