Template for comments
Date: 10.08.2022
Document: MTR/Template new name Trend report document
Project:
NCA / Stakeholder1
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Proposed
23.02.2023
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PD
Manufacturer’s Trend Report
(MTR)
DRAFT Reporting Template Version 0.1
European Union Medical Devices Vigilance System
Section 1: Administrative information
1.1
Corresponding competent authori
23.02.2023
Datei
PD
Template for comments
Date: 22 Aug 2022
Document: MTR/ form or interface
Project:
NCA / Stakeholder1
Section
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Subclause
Type of comment2
Comments
Proposed change/Rationale
Subg
23.02.2023
Datei
PD
Draft document
Manufacturer’s trend report document - investigations, conclusions, and corrective actions
Part of the required data to enable the evaluation of the detected trend is provided thro
23.02.2023
Datei
PD
Manufacturer’s trend report document - investigations, conclusions, and corrective actions
Part of the required data to enable the evaluation of the detected trend is provided through The MTR Eudame
23.02.2023
Datei
PD
Questions and Answers on Trend reporting as outlined in the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Introducti
23.02.2023
Datei
PD
Template for comments
Date:
Trend report Q&A document
Project:
NCA / Stakeholder1
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Task force comment3
MPA
23.02.2023
Datei
PD
Taul1
Section Help text, concentrate on the trend report specific issues, those fields which are identical with the MIR will be according to the updated MIR and the structure of the form will be adj
23.02.2023
Datei
PD
Sheet1
Section Help text, concentrate on the trend report specific issues, those fields which are identical with the MIR will be according to the updated MIR and will be adjusted in the EUDAMED web
23.02.2023
Datei
PD
Template for comments
Date: 10.08.2022
Document: MTR/ help text
Project:
NCA / Stakeholder1
Line number
Clause/
Subclause
Type of comment2
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Proposed change/Rationale
Subgroup c
23.02.2023
Datei
PD
