Übersicht Healthcare

Release Notes & Roadmap

ReleaseTestumgebungProduktionScope
HTC 24.09n/a02.10.2024EUDAMED v2.14.0 Update

  • Supporting Message Version 2.0.12

EUDAMED EMDN Code List Alignments

Note:
  • 1WS removed the Special Device Type Code ORTHOPEDIC
HTC 24.0901.10.2024n/aEUDAMED v3.9.0 Update

  • Supporting Message Version 3.0.10

EUDAMED EMDN Code List Alignments
HTC 24.0820.08.2024n/aEUDAMED v3.9.0 Update

  • Supporting Message Version 3.0.10

EUDAMED Data Dictionary Alignments

Note:
  • EUDAMED removed the Special Device Type Code ORTHOPEDIC
HTC 24.05 Hotfix31.07.2024n/aEUDAMED v3.9.0 Update

  • Supporting Message Version 3.0.10
MC 24.05 Hotfix31.07.2024n/aEUDAMED v3.9.0 Update

  • Supporting Message Version 3.0.10
HTC 24.05n/a26.07.2024Package-DI Service Support

EUDAMED Data Dictionary Alignments

UDI-Manager - Bug Fixing

API - Bug Fixing

EUDAMED v2.14.0 Update

  • Supporting Message Version 2.0.12

Note:
  • EUDAMED removed the Storage and Handling Condition Type Code SHC047

  • Structure/Attribute change for Group Substatus
HTC 24.05 Hotfix 225.07.2024n/aEUDAMED UDI-Manager

  • Bug Fixing Critical Warnings / Storage Handling Conditions Management


EUDAMED v3.8.0 Update

  • Supporting Message Version 3.0.9
HTC 24.05 Hotfix26.06.2024n/aEUDAMED Data Dictionary Alignments for Critical Warnings / Storage Handling Conditions Management


EUDAMED v3.8.0 Update

  • Supporting Message Version 3.0.9


Note:
  • EUDAMED removed the Storage and Handling Condition Type Code SHC047

  • Structure/Attribute change for Group Substatus
HTC 24.0515.05.2024n/aPackage-DI Service Support

EUDAMED Data Dictionary Alignments

UDI-Manager - Bug Fixing

API - Bug Fixing

EUDAMED v3.8.0 Update

  • Supporting Message Version 3.0.9

Note:
  • EUDAMED removed the Storage and Handling Condition Type Code SHC047

  • Structure/Attribute change for Group Substatus
MC 24.05 Hotfix15.05.2024n/aEUDAMED v3.8.0 Update

  • Supporting Message Version 3.0.9

Note:
  • EUDAMED removed the Storage and Handling Condition Type Code SHC047
HTC 24.02 Hotfixn/a25.03.2024EUDAMED Versioning Workaround

EUDAMED v2.14.0

  • Supporting Message Version 2.0.12
MC 24.02n/a22.03.2024New atrify UDI Solution Enhancements

  • EUDAMED Versioning Workaround

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

EUDAMED v2.14.0

  • Supporting Message Version 2.0.12
HTC 24.02 Hotfix21.03.2024n/aEUDAMED Versioning Workaround

EUDAMED v3.7.0

  • Supporting Message Version 3.0.8
MC 24.0212.03.2024n/aNew atrify UDI Solution Enhancements

  • EUDAMED Versioning Workaround

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

EUDAMED v3.7.0

  • Supporting Message Version 3.0.8
MC 24.01 Hotfixn/a14.02.2024EUDAMED v2.14.0 Update

  • Supporting Message Version 2.0.12
HTC 24.01 Hotfixn/a14.02.2024EUDAMED v2.14.0 Update

  • Supporting Message Version 2.0.12
MC 24.01 Hotfix31.01.2024n/aEUDAMED v3.7.0 Update

  • Supporting Message Version 3.0.8

HTC 24.01 Hotfix31.01.2024n/aEUDAMED v3.7.0 Update

  • Supporting Message Version 3.0.8

MC 23.11n/a13.12.2023New atrify UDI Solution

  • M2M API Import via atrify XML

  • Eudamed & FDA GUDID Connectors

  • UDI Manager Hitlist&Editor

  • UDI Manager Message History

  • Excel Up-/Download

  • User and Company Management

  • Download Center: Relevant Documents

  • MarketInfo Service Support

EUDAMED v2.13.0

  • Supporting Message Version 2.0.11
MC 23.1113.12.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

  • MultiDescription Support (language, text)

  • MarketInfo Service Support

EUDAMED v3.6.0

  • Supporting Message Version 3.0.7
HTC 23.10 Hotfixn/a22.11.2023EUDAMED v2.13.0 Update

  • Supporting Message Version 2.0.11
MC 23.1010.11.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

EUDAMED v3.6.0 Update

  • Supporting Message Version 3.0.7
HTC 23.10n/a09.11.2023EXCEL Template Processing Bug Fixes

UDI Manager Device Status Update Bug Fix
HTC 23.1009.11.2023n/aEUDAMED v3.6.0 Update

  • Supporting Message Version 3.0.7

EXCEL Template Processing Bug Fixes

UDI Manager Device Status Update Bug Fix
HTC 23.08 Hotfixn/a21.09.2023EUDAMED v2.12.0 Update

  • Supporting Message Version 2.0.10
MC 23.08
08.09.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Minor Front End Improvements

  • UDI Manager - Back End Improvements

  • Supporting EUDAMED Message Version 3.0.5

HTC 23.08 Hotfix08.09.2023n/a EUDAMED v3.5.0 Update

  • Supporting Message Version 3.0.5
MC 23.0707.08.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Eudamed Legacy Device Type Support

  • UDI Manager - Hitlist&Editor Improvements

  • Supporting Message Version 3.0.4

HTC 23.06 Hotfixn/a11.07.2023EUDAMED v2.11.0 Update

  • Supporting Message Version 2.0.8
HTC 23.06 Hotfix30.06.2023n/a EUDAMED v3.4.0 Update

  • Supporting Message Version 3.0.4
MC 23.05
26.05.2023atrify UDI Solution v. MC-1
New atrify UDI Solution

  • M2M API Import via atrify XML

  • Eudamed & FDA GUDID Connectors

  • UDI Manager Hitlist&Editor

  • UDI Manager Message History

  • Excel Up-/Download

  • User and Company Management

  • Download Center: Relevant Documents

HTC 23.02 Hotfix10.03.202310.03.2023EUDAMED Access Point Issue

  • Workaround with special nodeID in EUDAMED XML Header

  • Enhanced Token Manager to maintain special nodeID per SRN

HTC 23.0201.02.202302.02.2023

  • Market Info PUT Service

  • Minor Bugfixes

HTC 22.1206.12.202206.12.2022

  • PRODUCTION: Urgent EUDAMED v2.0.6 Update

  • Increased Excel Upload Device Limitation

HTC 22.1116.11.2022NA

  • EUDAMED v2.0.6 Update

  • Various Bugfixes

  • Document Update: atrify2EUDAMED Data Model v1.14.0

  • Document Update: Excel Template v1.14.0

HTC 22.0805.09.202205.09.2022

  • EUDAMED v2.0.4 Update

  • Hitlist: API: The possibility to send an UDI-DI that does not overwrite the existing packages

  • Hitlist: Search for legacy devices updated to regulation

  • Various Bugfixes

  • Document Update: atrify2EUDAMED Data Model v1.13.0

  • Document Update: Excel Template v1.13.0

HTC 22.0607.07.202207.07.2022

  • Hitlist: Textview for Response XML

  • Hitlist: New Filter for SRN

  • Support for multiple errors in EUDAMED responses

  • Multiple UDI Registration on same Basic using bulk

  • Zap Security Scan Auto Ticketing

  • Bugfix: GET Registration request causes error + missing message history

  • Document: UDI Manager User Manual Update

  • Document: API Documentation Update

HTC 22.0402.05.202202.05.2022

  • Delete Process API/UI

  • Resubmission Process

  • New Report Section

  • Register same UDI-DI for different legislations

  • UX: For Basic-UDIs show amount of related UDIs

  • Production Update EUD v. 2.0.2

HTC 22.0221.02.2022Pending Eudamed Production v. 2.0.2 update

  • Hit list - CSV download

  • Hit list - Bulk send and registration status request

  • Hit list - Optimization styling e.g. Show Version for Devices

  • Response message warning support

  • New Italian language support

  • Corporate design configuration support

  • Message history for Basic-UDI´s

HTC 21.1213.12.2021Pending Eudamed Production v. 2.0.2 update

  • EUD 2.0.2 Support

  • EUD Device Registry Status API

  • UX Fine Tuning

HTC 21.1116.11.202116.11.2021

  • Production Instance Launch

  • EUD 2.0 Support

  • UX: Legacy Forms Refactoring

  • UX: Hybrid Support to Link m2m Devices in the UDI Manager

  • UX: Token Management

  • New Download Area

HTC 21.1014.10.202114.10.2021

  • EUD 1.5.1 Support

  • Update Patch Support

  • UX Fine Tuning (esp. Excel and Forms)

ReleaseTestumgebung / DemoProduktionScope
atrify UDI Solution v. MC-1 v23.11n/a13.12.2023New atrify UDI Solution

  • M2M API Import via atrify XML

  • Eudamed & FDA GUDID Connectors

  • UDI Manager Hitlist&Editor

  • UDI Manager Message History

  • Excel Up-/Download

  • User and Company Management

  • Download Center: Relevant Documents

  • MarketInfo Service Support

EUDAMED v2.13.0

  • Supporting Message Version 2.0.11
atrify UDI Solution v. MC-1 v23.1113.12.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

  • MultiDescription Support (language, text)

  • MarketInfo Service Support

EUDAMED v3.6.0 Update

  • Supporting Message Version 3.0.7
HTC 23.10 Hotfixn/a22.11.2023EUDAMED v2.13.0 Update

  • Supporting Message Version 2.0.11
HTC 23.10n/a09.11.2023EXCEL Template Processing Bug Fixes

UDI Manager Device Status Update Bug Fix
HTC 23.1009.11.2023n/aEUDAMED v3.6.0 Update

  • Supporting Message Version 3.0.7

EXCEL Template Processing Bug Fixes

UDI Manager Device Status Update Bug Fix
atrify UDI Solution v. MC-1 v23.1010.11.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Bug Fixing

  • API - Bug Fixing

EUDAMED v3.6.0 Update

  • Supporting Message Version 3.0.7
HTC 23.08 Hotfixn/a21.09.2023EUDAMED v2.12.0 Update

  • Supporting Message Version 2.0.10
atrify UDI Solution v. MC-1 v23.0805.09.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Minor Front End Improvements

  • UDI Manager - Back End Improvements

  • Supporting EUDAMED Message Version 3.0.5

HTC 23.08 Hotfix05.09.2023n/a EUDAMED v3.5.0 Update

  • Supporting Message Version 3.0.5
atrify UDI Solution v. MC-1 v23.0707.08.2023n/aNew atrify UDI Solution Enhancements

  • UDI Manager - Eudamed Legacy Device Type Support

  • UDI Manager - Hitlist&Editor Improvements

atrify UDI Solution v. MC-1DEMO: 20.03.2023n/aNew atrify UDI Solution

  • M2M API Import via atrify XML

  • Eudamed & FDA GUDID Connectors

  • UDI Manager Hitlist&Editor

  • UDI Manager Message History

  • Excel Up-/Download

  • User and Company Management

  • Localisation EN-DE-IT-JP

  • Download Center: Relevant Documents

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