EUDAMED UDI Medical Devices User's Guide

Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#4
Are you sure you can share it? I did not find it either (although I'm not sure, because the EC website has been revamped and my links to docs are not working anymore), but Eudamed is being tested at the moment by the people involved (and this is the type of document that would be part of that, although not for public yet).
 

fialor

Involved In Discussions
#5
Are you sure you can share it? I did not find it either (although I'm not sure, because the EC website has been revamped and my links to docs are not working anymore), but Eudamed is being tested at the moment by the people involved (and this is the type of document that would be part of that, although not for public yet).
It does not say that it cannot be shared though, (looking over shoulder!) :cool:
 

Marcelo

Inactive Registered Visitor
#6
Ok, however, usually when documents are distributed to people with the knowledge, they do not say that they cannot be shared, people simply know. As you seem not to know if this document can be shared or not, I will take the precautious way and remove it as the Cove cannot be used for sharing documents which are not intended to be shared.
 
Last edited:

fialor

Involved In Discussions
#7
Ok, however, usually when documents are distributed to people with the knowledge, they do not say that they cannot be shared, people simply know. As you seem not to know if this document can be shared or not, I will take the precautious way and remove it as the Cove cannot be used for sharing documents which are not intended to be shared.
Thanks Marcelo. The email I received did not say it was not a shareable document but I take your point.
 
Thread starter Similar threads Forum Replies Date
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
Watchcat Whatever happened to Eudamed 1.0? EU Medical Device Regulations 5
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
M Informational EU – Official position on EUDAMED delay Medical Device and FDA Regulations and Standards News 6
M Informational EU – Possible EUDAMED delay Medical Device and FDA Regulations and Standards News 3
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 10
M Informational Eudamed Data Exchange Guidelines Medical Device and FDA Regulations and Standards News 0
M Informational EU – Eudamed Data exchange services and entity models introductions Medical Device and FDA Regulations and Standards News 4
M Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Medical Device and FDA Regulations and Standards News 0
shimonv Informational New guidance documents about EUDAMED - April 2019 EU Medical Device Regulations 1
M Informational MDCG 2019-5 Registration of legacy devices in EUDAMED Medical Device and FDA Regulations and Standards News 11
M Informational MDCG 2019-4 Timelines for registration of device data elements in EUDAMED Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
M Informational Plan for the CND nomenclature (for EUDAMED use) Medical Device and FDA Regulations and Standards News 4
N Notified Body excessive reporting onto Competent Authorities via the Eudamed database ISO 13485:2016 - Medical Device Quality Management Systems 7
Ronen E Eudamed - Public Access - Directive 2007/47/EC preamble EU Medical Device Regulations 2
G IVD EU Notifications - May 2011 deadline for mandatory use of the Eudamed database EU Medical Device Regulations 7
Y Eudamed - European database for Medical Devices CE Marking (Conformité Européene) / CB Scheme 8
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom