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07 MDCG 2020-7 Guidance on PMCF Plan Template.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-7
1
MDCG 2020-7
Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordin... |
06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-6
MDCG 2020-6
Regulation (EU) 2017/745: Clinical evidence needed for
medical devices previously CE marked under
Directives 93/42/EEC or 90/385/EEC
A guide for manufacturers and notifie... |
mdcg_clinical_evaluationtemplate_en.pdf.txt | Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
0
MDCG 2020-13
Clinical evaluation assessment report template
July 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) estab... |
MDCG 2020-1.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-1
MDCG 2020-1
Guidance on Clinical Evaluation (MDR)
/ Performance Evaluation (IVDR) of
Medical Device Software
March 2020
This document has been endorsed by ... |
mdcg_2019_9_sscp_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-9
1(24)
MDCG 2019-9
Summary of safety and clinical performance
A guide for manufacturers and notified bodies
August 2019
This document has been endorsed by the Medical Device Coordina... |
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