Eudamed actor registrations if you change AR for MDR product

Awadine

Involved In Discussions
#1
Hi

Hoping for some advice so I can get actor registrations correctly completed in Eudamed before we start registering devices.

We are a non-EU manufacturer currently using Authorised Rep A for Legacy MDD product placed on the EU market. When we transition to MDR certification, we will be using Authorised Rep B for our MDR device portfolio. But we are likely to continue to place MDD product on the EU market under AR A for several years after we get MDR certification.

How do we set this up correctly in the Eudamed actor module so legacy product can be assigned to AR A and MDR product can be assigned to AR B?

Each manufacturer entity can only assign 1 AR entity in Eudamed. Is there a simple way to address this that I am missing?

Many thanks.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
N Actor registration EUDAMED restricted: got no Email to complete the registration EU Medical Device Regulations 9
I Legacy device EUDAMED registration EU Medical Device Regulations 7
B EUDAMED 2 Different Registration EU Medical Device Regulations 1
S Evidence of EUDAMED Registration ISO 13485:2016 - Medical Device Quality Management Systems 2
M EUDAMED Registration tracker EU Medical Device Regulations 4
C Issues with UDI-DI and LAA/LUA registration in Eudamed EU Medical Device Regulations 2
Ed Panek EUDAMED Timeline EU Medical Device Regulations 2
S How to upload data in bulk on EUDAMED? EU Medical Device Regulations 13
I Eudamed UDI-Module EU Medical Device Regulations 9
marmotte MDD legacy until 2024 - EUDAMED, role (and cost!) of the EC Rep EU Medical Device Regulations 6
S Eudamed data fields EU Medical Device Regulations 5
D High level understanding of EUDAMED EU Medical Device Regulations 3
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
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 10
M Informational EU – Official position on EUDAMED delay Medical Device and FDA Regulations and Standards News 9
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 19
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
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
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets 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 5
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
Marc Lou Rawls, R&B Singer and Actor, Is Dead of cancer at 72 World News 2
SteelMaiden "Gilligan's Island" actor Bob Denver dies at age 70 World News 8
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
L Combining 3 ISO 9001 registrations into 1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Class I - International Registrations EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Brazil: Termination of business relations with BRH – what happens to registrations? Other Medical Device Regulations World-Wide 1
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
F Class IIa/b in-country registrations x5 ? Other Medical Device Regulations World-Wide 1
F EU IVD registrations - CFG or CFS - Differences EU Medical Device Regulations 1
L List of Regulated Countries - Registrations on Medical Devices Class I / II / III Other Medical Device Regulations World-Wide 2
3 Egypt: Multiple Registrations of the Same Product Other Medical Device Regulations World-Wide 2
3 Multiple registrations / authorized representatives in Iran Other Medical Device Regulations World-Wide 4
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Q CE Class I Medical Devices (Instruments) - Germany Registrations CE Marking (Conformité Européene) / CB Scheme 1
Q Transferring EPA Registrations - Timeline? Various Other Specifications, Standards, and related Requirements 3

Similar threads

Top Bottom