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#1EUDAMED Actor註冊模組上線介紹
依據MDCG 2020-15的立場聲明 2 ,Actor註冊模組為將來使用其他模組的前提,因此MDCG強烈建議有關人員註冊,以獲取並使用SRN(單一註冊碼)。依據2020年3月12日 ...
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#2EUDAMED完成UDI/Devices and NBs 及Certificates模組上線
EUDAMED 資料庫是由六個模組組合,包括:使用者註冊(Actor Registration)、醫療器材單一標識(UDI)和產品註冊(unique device identification (UDI) and ...
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#3歐盟醫療器材資料庫(EUDAMED)概述 ... - M.D.'s Blogger - 痞客邦
5. 使歐盟成員國和委員會的主管機關能夠在充分知情的基礎上執行與MDR有關任務,並加強彼此之間的合作。 而醫療器材資料庫(EUDAMED)的使用模組包括:. 1. 醫療器材的註冊 ...
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#4最新歐盟EUDAMED日期 - 愛姆斯的醫材藥品法規世界
歐盟委員會European Commission,已經表明會讓部份EUDAMED模組提早在明年先上線。 (EUDAMED有幾種不同的模組像是證書、UDI、註冊、Vigilance等,醫材 ...
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#5EUDAMED database - European Commission
EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and ...
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#6EUDAMED數據庫執行時間的重要調整 - 理衛國際LeadtheWay
2021年的第一份MDCG指引文件比以往來得更早一些。這份指南文件主要是跟EUDAMED數據庫的執行時間相關。之前的公告曾提到要等到所有功能模組都上線6個月之後,EUDAMED ...
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#7Medical Device Regulatory Updates
The development and implementation of EUDAMED is a high priority for the ... UDI/器械註冊模組(第二個模組)和證書和公告機構模組(第三個模組)預計將於2021年5月 ...
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#8European Union: EUDAMED Actor Registration Module Will ...
EUROPEAN UNION: EUDAMED Actor Registration Module Will be Available From December 2020 – November, 2020. 2020-11-26. Transparency and coordination of ...
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#9Eudamed modules for UDI, Notified Body certifications now ...
UDI/Devices Registration: Economic operators will enter UDI and registration information for devices into this module; Notified Bodies and ...
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#10Eudamed - HPRA
Eudamed · The Eudamed actor module can be found at the following location: · The UDI / Device registration module were made available on a voluntary basis on the ...
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#11Explanation EUDAMED Database Structure - Europe IT ...
This module allows manufacturers (actors) to register and later be clearly identified. The actors include manufacturers, importers and EU representatives. After ...
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#13[Blog] EUDAMED – the key role of each module - SoftGroup
What you need to know about each EUDAMED module? Actor registration – registration of the different actors in the medical device field; UDI/ ...
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#14臨床試驗的MDR 實施計畫
這份指南能暫時為試驗委託者提供支援和建議,直到EUDAMED 的臨床試驗模組於2022 年5 月開始完整運作為止,屆時新的體外診斷醫療器材法規(Regulation ...
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#15MQ Traceability Suite UDI EUDAMED Module - Alysidia
MQ Traceability Suite - UDI Module allows manufacturers to seamlessly associate UDIs to medical device products according to MDR and EUDAMED.
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#16EUDAMED and the UDI and Device Registration module - BSI ...
The UDI and Device Registration module (originally two separate modules within EUDAMED) is one of six. The other modules are:.
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#17EUDAMED 'UDI/DEVICE REGISTRATION' MODULE 2 IS ...
This means that Medical Device manufacturers are now able to upload all the information related to their MDR devices on a voluntary basis until ...
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#18EUDAMED UDI module live! | atrify
Following the release of the Actor module, which has been operational since December 2020, the UDI and CERTIFICATE modules in EUDAMED were ...
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#19[10B313]EU MDR法規符合性負責人(PRRC)培訓課程Medical ...
企業須為委任的PRRC提出資格證明,並在Eudamed將PRRC與製造商一起註冊。 ... 法規內容,以適用廠內產品的風險等級,本課程將EU MDR的要求劃分成7個獨立的主題模組,您 ...
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#20EUDAMED-Module | Website Template
EUDAMED -Module · Registrierung der Wirtschaftsakteure · UDI/Medizinprodukte-Registrierung · Benannte Stellen und Zertifikate · Klinische Studien und ...
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#21The first module of EUDAMED on Actor registration to be ...
The first module of EUDAMED on Actor registration to be launched in December. Posted on 05.11.2020. The European Commission has launched a new dedicated ...
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#22Eudamed launched with actor registration module live | RAPS
The European Commission's Eudamed database, a critical component of the EU's Medical Devices Regulation (MDR) and In Vitro Diagnostic ...
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#23Online EUDAMED modules UDI/devices and Notified Bodies ...
EUDAMED database · Economic operators' registration (“Actor registration module”) available from December 1 st, 2020. · UDI/ Devices registration.
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#24First EUDAMED Module Live – Here's What You Need to Know
The European Database for Medical Devices (EUDAMED), is a major part of the European Union's new medical device and IVD regulations (EU MDR ...
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#25MDR-IVDR bottleneck persists as EU launches 1st Eudamed ...
MDR-IVDR bottleneck persists as EU launches 1st Eudamed module. "Very few notified bodies at this moment in time are taking new products on ...
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#26Base de données EUDAMED pour les dispositifs médicaux
Le module DM/IUD de la base Eudamed est désormais disponible. ... Nous rappelons également aux opérateurs du marché de consulter les dispositions ...
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#27[ARTICLE] Incident reporting until release of the EUDAMED ...
Until the EUDAMED Vigilance module is operational, manufacturers shall continue to report incidents to National Competent Authority(ies).
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#28The Six EUDAMED Modules (MDR) - tracekey solutions GmbH
The six EUDAMED modules · Actor Registration Module (available since December 2020) · UDI/Medical Devices Registration Module · Notified Bodies and Certificates ...
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#29EUDAMED: Launch of the economic actors' registration module
The European Commission has recently rolled out the first EUDAMED module called “Actor registration module” and intended for economic ...
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#30EUDAMED - Current Status of the Database for Medical Devices
According to the European Commission, the development of EUDAMED is progressing. The first EUDAMED module for actor registration went live in ...
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#31EUDAMED3 Update: Two More Eudamed Modules Will Be ...
Market Surveillance. The Actor Registration module became active December 1, 2020. The European Commission has officially confirmed that two ...
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#32醫療器材法規小學堂- #Eudamed #UDI_Device_Module... | Facebook
Eudamed #UDI_Device_Module DELAY!!DELAY!!DELAY!! Eudamed 總共有6大模組功能自從Dec 2021 上線的第一個模組Actor Module 後原本預計May 2021 要上線的第二模 ...
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#33Medical devices in the EU - Update on EUDAMED database
The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, ...
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#34EUDAMED - Qserve
EUDAMED · EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market. · The module on Actor ...
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#35EUDAMED | Obelis Group
From December 2020, EUDAMED Actor registration is possible. From September 2021, second and third module of EUDAMED will become active (UDI/device registration ...
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#38All you need to know about Actors in EUDAMED - Avanti Europe
The EC has implemented module 1 of the EUDAMED database for MDR and IVDR. Learn how to register actors and economic operators.
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#39EUDAMED 註冊 :: 合法醫療器材資訊網
合法醫療器材資訊網,EUDAMED SRN,EUDAMED,EUDAMED actor registration,eudamed中文 ... (EUDAMED有幾種不同的模組像是證書、UDI、註冊、 ...,2021年5月4日—歐盟委員會 ...
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#40Actor registration module now available on EUDAMED - GS1 UK
On 1 December 2020, the European Commission made available the Actor registration module for the EUDAMED.
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#41EUDAMED 1st Module - Actors' Registration ...
EUDAMED first module on actors registeration is going live for economic operators' registeration in December 2020.
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#42Medical device news - Plesner
Module 3 relates to notified bodies and certificates. EUDAMED is composed of six modules. Following the launch of the two new modules, it is now ...
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#43Update: EUDAMED Actor Module Now Planned for December ...
Now expected by 2021 Sept: EUDAMED Device/UDI Registration, Certificates and Notified Bodies modules (after the Actor module, as soon as ...
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#44EUDAMED Actor Registration Module! - Qarad
From 1 December 2020, the European Commission will make available the Actor registration module, which is the first of six EUDAMED modules, ...
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#45Recommendation on the EUDAMED UDI and Device ... - Fenin
MedTech Europe kindly requests that the European Commission and the EU Member States launch the. EUDAMED UDID module in production only ...
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#46EUDAMED: Actor Registration module now scheduled to ...
EUDAMED is a product and manufacturer database in which manufacturers must be entered in accordance with the new European regulations for ...
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#47EUDAMED Status Update 2021 - CRITICAL CATALYST
At the moment the European Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully ...
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#48Updated EUDAMED implementation dates | mdi Europa
The actor registration module went live on December 1, 2020. Until the more recent past, the UDI/ device registration module was planned to go ...
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#49Europe and EUDAMED - BfArM
The EUDAMED module "Actors" was released by the EU Commission on December 1, 2020. Economic operators can submit registrations according to MDR and obtain a ...
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#50Registration Requirements under the Medical Devices ...
EUDAMED - Actor Registration. Under the Actor registration module, economic operators across the supply chain (EU and non-EU manufacturers, ...
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#51Guidance Update - EUDAMED - Mason Hayes & Curran
Having launched the Actor Registration Module – the first of six planned modules making up the EUDAMED database, the European Commission ...
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#52Medical device regulation: first Eudamed module on line
It is the entering into function of the first module of Eudamed, the single European database introduced by the Regulations, that follows ...
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#53UDI assignment on EUDAMED
Moreover, the registration of devices and UDIs in the EUDAMED database is a pre-condition and an obligation for any manufacturer wishing to ...
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#54EUDAMED gradual roll-out - Welcome to Team NB
EUDAMED gradual roll-out. Here is the summary of decisions taken : • the UDI/Device module will be released in Production in September 2021.
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#55Medical Device Regulation: EUDAMED-Module freigegeben
Der MTD-Verlag ist ein Informations- und Dienstleistungsunternehmen für die Medizintechnik- und Hilfsmittelbranche mit dem Anspruch, ...
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#56EUDAMED Actor Registration Module: Device Safety | NAMSA
EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency ...
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#57Welke gegevens moeten fabrikanten, gemachtigden en ...
De volgende module van EUDAMED die live gaat is de module om producten te registreren. Naar verwachting gebeurt dit het tweede kwartaal van 2021. Fabrikanten ...
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#58Eudamed-Module: Geheimniskrämerei?
Im zwölften Teil unserer Kolumne der Regulatory-Affairs-Experten von Seleon geht es um die Eudamed-Module. Gibt es da Aktualisierungen?
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#59EC updates FAQ on EUDAMED Actor Module - HIBCC
The Actor Registration Module is the first of six interconnected modules in EUDAMED and enables economic operators to request an Actor ID/SRN ( ...
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#60EUDAMED is LIVE - Brandwood CKC
An update on the European Databank on Medical Devices (EUDAMED). ... a modular implementation of the database and the first EUDAMED module, ...
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#61route to eudamed: the new actor registration module active soon
The full implementation of EUDAMED is expected from 26 th May 2022. However, the European Commission has planned a progressive module by module ...
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#62Guidance for Actor Registration Module in EUDAMED (V1 - SGS
user, for a registered economic operator? See section 2.2.1. Page 7. EUDAMED Actor module user guide – for economic operators.
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#63EC Announces the Launch of Actor Registration Module
Consequently, the medical device manufacturers based in the UK would not be able to register in EUDAMED. At the same time, the European ...
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#64A checklist to prepare for EUDAMED Actor Module registration
Latest checklist to prepare for EUDAMED (European Database on Medical Devices) Actor Module registration as per EU MDR 2017/745.
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#65The MDR countdown has started. A summary of the latest ...
Eudamed Module II (for UDI/device registration) and Module III (for certificates and notified bodies) are to be available by September 2021. 4. Increased use of ...
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#66New EU requirements for medical devices - GS1
individualisation to reduce the volume of data entries in the UDI module of EUDAMED. (i.e. the EU UDI database). Also, additional Application Identifiers ...
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#67Are you prepared for EUDAMED actor registration module ...
The EU Commission Decision for EUDAMED, the European Databank for Medical ... on “Actor Registration Module” which is key to accessing and using EUDAMED.
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#68EUDAMED Actor registration module - MTAA - Medical ...
EUDAMED Actor registration module. The EUDAMED database is a key enabling feature (central database and collaboration tool) of the new ...
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#69European Commission publishes webpage on EUDAMED ...
The European Commission has published a webpage dedicated to the EUDAMED actor registration module. The webpage provides links to ...
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#70EUDAMED : Enregistrement des acteurs - AFMPS
Eudamed : European database on medical devices – Base de données sur les dispositifs médicaux ... Qui peut s'enregistrer dans le module acteur d'Eudamed ?
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#71EUDAMED UDI / device registration module postponed to ... - p36
EUDAMED UDI / device registration module postponed to September 2021. Last week the EC announced on their website that the availability of the MVP (Minimum ...
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#72EUDAMED UPDATE: Actor Registration Module - Innovit AUS
European Commission just announced the availability of the EUDAMED Actor Registration module for voluntary, production use by Member States and ...
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#73EU: EUDAMED UDI/device registration and Certificates and ...
The European Commission announced the activation of the modules on UDI/device registration (second module) and on Certificates and Notified ...
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#74Asphalion on Twitter: " FREE WEBINAR - Twitter
FREE WEBINAR | #EUDAMED MODULE 2 17/11/2021 3:00 p.m. (CET) ➡️ Would you like to know everything about #Data #submission related to this module?
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#75Eudamed Registration Module to Launch in December
The European Commission's Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December ...
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#76Legacy Devices Under EUDAMED - EMMA International
While the long wait for EUDAMED is over, the industry is now ready to start registrations using the new module. It will be interesting to see ...
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#77Parsek registered as a Medical Device Manufacturer in ...
We are proud to announce that Parsek is registered as an Economic Operator (EU) in the lately launched EUDAMED module for actor registration ...
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#78EUDAMED Actor registration module - LinkedIn
The long-awaited EUDAMED database is finally beginning to become reality with the first module on Actor registration released on December ...
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#79What's The Fuss About? Guide to EUDAMED | Celegence
A sample of the SRN is depicted in figure 1 below. Table 1: Modules of EUDAMED and their Availability. Electronic system, EC Module Ref ...
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#80SRN, the new important number - Regulatory Affairs
From 1.12., economic operators will register in the EUDAMED ... Paper on the use of the EUDAMED actor registration module and of the Single ...
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#81EUDAMED User guide (Actor Module) Version 0.1
Medical device CE marking. EUDAMED User guide (Actor Module) Version 0.1. 1 September 2020. Version. Download, 15. Stock, ∞. Total Files, 1. Size, 0.00 KB.
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#82Everything you need to know about the EUDAMED actor ...
The actor registration module is the first of six EUDAMED (European Database on Medical Devices) modules to be released.
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#83EUDAMED: European Database on Medical Devices - Johner ...
Die ersten Module der EUDAMED sind bereits entwickelt. Die Entwickler (und die EU) gingen davon aus, dass die EUDAMED pünktlich zum 26. März(!) 2020 live gehen ...
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#84Step 7. Register the device and the manufacturer
MDCG 2020-15 Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States ...
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#85Europe - MDCG 2020-15 : Position Paper on the use of the ...
Europe – MDCG 2020-15 : Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number in the ...
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#86Q&A: UDI Registration in EUDAMED - USDM Life Sciences
It would get its own record in the Device Registration and UDI Database module in the European Database on Medical Devices (EUDAMED). It would have two ...
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#87EUDAMED Registration For Medical Devices - I3CGLOBAL
Step II – Registration of manufacturers, EU Rep and importers. The economic operators should register themselves in the “Actor Registration Module”, where the ...
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#88EUDAMED: “Actor Registration Module” freigeschaltet
EUDAMED : “Actor Registration Module” freigeschaltet. Tuttlingen – Erstes EUDAMED-Modul geht live. Die Europäische Kommission hat Anfang Dezember mit dem “Actor ...
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#89EUDAMED Delay Brings Little Comfort to Medical Device ...
7 December 2020 Update: After some delays the first module of the European database on medical devices (EUDAMED) is live!
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#90Une nouvelle vidéo de DM Experts : « Eudamed
Une nouvelle vidéo de DM Experts : « Eudamed : module d'enregistrement des acteurs, démonstration pour un fabricant situé dans l'UE » · Nouvelles ...
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#91Eudamed Actor Registration Module on track for December ...
More recently, on 20 th October 2020, the European Commission provided an update relating to the Eudamed actor registration module.
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#92EUDAMED - Actor registration module freigeschaltet
Die Europäische Kommission hat zu Anfang Dezember das erste von insgesamt sechs Modulen, das „Actor registration module“, der neuen EUDAMED freigeschaltet.
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#93EUDAMED and EU Medical Device Nomenclature - MakroCare
1st Module set: Manufacturers or EO are needed to submit/register the information for Device registration, UDI registration, certificates and ...
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#94Commission Publishes Demo of Eudamed Actor ... - PAGB
Home > Regulatory Resources > Self Care Medical Devices > Commission Publishes Demo of Eudamed Actor Registration Module ...
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#95New MDCG document outlines harmonised practices ... - ISS AG
With the MDR fully applying on 26 May 2021, the actor registration module is the only and first of the Eudamed modules currently available. The ...
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#96First Module of EUDAMED on Actor Registration Open - Qualio
The European Commission has launched registration for the first module of the future European Medical Device Database.
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#97Multiple guidance documents issued for Eudamed 'Actor ...
The actor registration module will be the first of six Eudamed modules to be available for use, with the remainder being phased in between now ...
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#98MDCG publishes position paper on use of EUDAMED actor ...
... Device Coordination Group (MDCG) has issued a position paper on the use of the European database on medical devices (EUDAMED) actor registration module ...