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, 2023
Notification of a body in the framework of a technical harmonization directive
5 Nov, 2023
European Commission June 2022 update to EUDAMED Timeline
6 Jul, 2023
MDR EUDAMED - Data Exchange Notes
18 Oct, 2023
Overview of NB's at each stage of the process
18 Oct, 2023
UDI/Devices User Guide
28 May, 2023
Data Exchange Guide and Release Notes.
18 Oct, 2023
Actor Module FAQs
27 Sep, 2023
Actor module FAQs
28 Oct, 2023
Summary of safety and clinical performance. A guide for manufacturers and notified bodies.
1 Mar, 2023
Q&A on UDI under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
1 May, 2023
State of Play and Roadmap as of April 2022
28 Apr, 2023
2.7.0 and 3.0.0 overview
28 Apr, 2023
EUDAMED Experience of Notified Bodies
28 Apr, 2023
Meeting of the Medical Devices Coordination Group with stakeholders
28 May, 2023
Codes reflecting the design and intended purpose of the device.
28 Oct, 2023
Overview of NB'S at each stage of the process.
28 May, 2023
Codes reflecting the design and intended purpose of the device.
28 Oct, 2023
Codes reflecting the design and intended purpose of the device.
28 Oct, 2023

Featured eBook

EUDAMED FAQ For Compliance

Today, Medical Device manufacturers are staring down the barrel of a number of critical compliance deadlines specific to EUDAMED (European Database for Medical Devices) and you need to know the processes and systems that can simplify this journey. This eBook is intended to serve as a reference tool and mini-guide book as your team navigates the complexities of Medical Device Regulations (EU-MDR).