EU Commission
Documents & Guidance

EU Commission Documents & Guidance

Type
Name
Version
Release Date
Archive
Draft Meeting Minutes of 11th MDR EUDAMED Vigilance WG
3 Mar, 2022
Notification of a body in the framework of a technical harmonization directive
5 Nov, 2022
European Commission June 2022 update to EUDAMED Timeline
6 Jul, 2022
MDR EUDAMED - Data Exchange Notes
18 Oct, 2022
Overview of NB's at each stage of the process
18 Oct, 2022
UDI/Devices User Guide
28 May, 2022
Data Exchange Guide and Release Notes.
18 Oct, 2022
Actor Module FAQs
27 Sep, 2022
Actor module FAQs
28 Oct, 2022
Summary of safety and clinical performance. A guide for manufacturers and notified bodies.
1 Mar, 2022
Q&A on UDI under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
1 May, 2022
State of Play and Roadmap as of April 2022
28 Apr, 2022
2.7.0 and 3.0.0 overview
28 Apr, 2022
EUDAMED Experience of Notified Bodies
28 Apr, 2022
Meeting of the Medical Devices Coordination Group with stakeholders
28 May, 2022
Codes reflecting the design and intended purpose of the device.
28 Oct, 2022
Overview of NB'S at each stage of the process.
28 May, 2022
Codes reflecting the design and intended purpose of the device.
28 Oct, 2022
Codes reflecting the design and intended purpose of the device.
28 Oct, 2022

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