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Eudamed database timeline
Eudamed database timeline. Updated Timeline - Current planning for gradual roll out and modules’ functionality view. Jul 2, 2024 · An updated timeline for the mandatory implementation and use of the European Database on Medical Devices (EUDAMED) is now available. The Medical Device Coordination Group (MDCG) approved two further documents clarifying the timelines and requirements for using the EUDAMED database: Document 2019-4 confirms the deadline for registering device details in EUDAMED (Annex VI Part A, section 2, and Part B) will be either; (a) 18 months after the May 2020 application date, if Note:. D. The Commission expects EUDAMED to be fully functional in Q2 of 2023. the establishment of an electronic database for Unique Device Identification (the ‘UDI database’), which is part of the Eudamed database, in accordance with Article 28 of MDR and Article 25 of IVDR. Jul 17, 2024 · EUDAMED medical device and IVD registrations do not expire. 16 December 2022. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). 2. Download Devices or Systems or Procedure Packs purpose of EUDAMED is to improve transparency, and collaboration among all stakeholders including the public, with an emphasis on patient safety and clinical evidence. Q4 2023 Development of Minimum Viable Product (MVP) for all 6 modules to be completed. EUDAMED “is the IT system developed by the European Commission (EC) to implement Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The Commission has earlier proposed and advocated for the adoption of new provisions that allow for a gradual roll-out of the EUDAMED database. MedTech Europe says that five important conditions need to be met before any modules of EUDAMED are made mandatory. While some may lament the limited data analysis capabilities, EUDAMED Oct 30, 2019 · Eudamed is the database which will be used to monitor the safety and performance of devices and is part of the EU's broader overhaul of device regulation. When an actor is registered in EUDAMED, everyone who intends to act on behalf of this actor needs to submit an access request. The adoption of the EUDAMED Roll-Out Amendment in 2024-May drastically changed the previous draft EUDAMED Roadmap as the EC is now authorized to require use of individual EUDAMED modules that have been finalized, successfully audited, and declared functional without waiting for all six modules to be “fully functional. The remaining modules are scheduled for release when Eudamed is fully functional. Aug 27, 2024 · EUDAMED is a key aspect of the EU regulatory framework for medical devices, aimed at enhancing transparency by providing an overview of all medical devices available in the EU. 2. It will be a protected web application which will serves as a reference point for the flow of information between the European Commission (EC) and the national competent authorities. Keeping track of country-specific UDI requirements and timelines is a big challenge for RA teams. ARC has a range of SaaS digital products to enable and expedite your compliance. amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices Nov 27, 2020 · What is EUDAMED? EUDAMED is the IT system developed by the European Commission for the implementation of the new MDR 2017/745 and IVDR 2017/746. These timelines as based on the currently available EUDAMED plan, which assumes that the development of all six modules will be completed by the end of this year. As previously discussed, EUDAMED is designed to be a database. 14 March 2023. Jul 7, 2022 · Executive Summary. Jul 22, 2022 · EUDAMED new timeline. More information on the operational aspects of the registration of legacy devices is available at the MDCG 2019-5 guidance document. Criteria for EUDAMED Launch. 1. EUDAMED new timeline (adapted from “EUDAMED Timeline – The European Commission planning – June 2022″) It is expected a minimally viable version of EUDAMED to be developed until the last quarter of 2023. EUDAMED is the database of Medical Devices available on the EU Market. However, the Aug 30, 2023 · EUDAMED is the European database for medical devices. The European Commission has just released crucial information about the EUDAMED (European Database on Medical Devices) system following the meeting of EUDAMED subgroup in June. Sep 25, 2020 · The Directives also require that data be stored in a database in a standardized format. Many adjustments took place because of the effect of the COVID pandemic, including the EUDAMED database launch. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. While some modules are already available, European The EMDN is the nomenclature to be used by manufacturers when registering their medical devices in EUDAMED. The European Commission has published an updated timeline for delivering the EU medical device database. The EU postponed the intended timeline in June 2022. Oct 3, 2022 · To accomplish this goal, the regulations call for a multipurpose database known as the European Database for Medical Devices (EUDAMED). DDG1. zu EUDAMED. g. Regarded as the cornerstone of the EU medical device and IVD regulations, the Eudamed database will have been delayed by four years and there are transition periods ahead. Nov 27, 2020 · Timelines for data registration in EUDAMED: The full functionality of the EUDAMED database is expected to be reached in May 2022 (1) following the release of the Vigilance module. This version delays important milestones by exactly 1 year, meaning the “full functionality” of EUDAMED is delayed as well. May 23, 2020 · The European Commission decided that its database of medical device information (Eudamed) will be onlineonce when all modules are fully functional, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics in May 2022, in parallel with the new EU MDR 2017/745. Timelines for registration as described under question 6 also apply to these products. Jul 10, 2024 · Latest updates. Click this link to go to the EUDAMED database. According to the Commission, some of the modules for the new Eudamed 3 database will be in operation about the same time as Regulation (EU May 26, 2021 · The obligation for submission of UDI data in the EUDAMED database: this obligation applies 24 months after EUDAMED has become fully functional. It is recommended to monitor the EC website for further updates to the EUDAMED timeline. No new timeline was uploaded in its place. From the ARC360® Regulatory Navigator, developed to provide the requirements for utilising IVDs/CDx in precision medicine clinical trials to the ARC360® Laboratory Toolkit, designed to provide a step-by-step guide for EU Health Institutions to comply with IVDR Article 5(5) (the in-house Jul 4, 2024 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. Jul 11, 2022 · The EU Commission updated the EUDAMED timeline chart again this month, with a new ‘go-live’ date of Q2 2024. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. The official web address of the EUDAMED public website is https://ec. To view the EC EUDAMED Timeline click here. 4. 0 – September version”). The EMDN is fully available in the EUDAMED public site. The EUDAMED full functionality date of Q2 2024 and dates included for the end of the transitional timeframe & mandatory use beginning, are taken from the last available public EUDAMED timeline published on the EC website (which is no longer available). Under the new timeline, the go-live of EUDAMED’s six modules takes place in the fourth quarter of 2023. Mai 2021, dem Geltungsbeginn der EU-Verordnung 2017/745 für Medizinprodukte, Fragen & Antworten zum Geltungsbeginn der EU-Vorschriften für die Sicherheit von Medizinprodukten veröffentlicht, u. These regulations affect the work of manufacturers and also the work of authorities and notified bodies. Jun 7, 2024 · These legacy devices are not subject to UDI obligations but they should be registered in the Eudamed database. Aug 9, 2024 · MDCG 2019-5 Registration of legacy devices in EUDAMED; MDCG 2019-4 Timelines for registration of device data elements in EUDAMED; The European Commission has also established several web-pages dedicated to EMDN and EUDAMED, including a help desk. On June 2022, the European Commission issued a new timeline planning for the EUDAMED. 7. ” Aug 28, 2023 · The EU Commission recently removed the EUDAMED implementation timeline chart from its website. MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States: August 2020: MDCG 2019-5: Registration of legacy devices in EUDAMED: April 2019: MDCG 2019-4: Timelines for registration of device data elements in EUDAMED: April 2019 Oct 23, 2023 · Based on the updated timeline, it does not appear that EUDAMED will be deemed fully functional until at least Q2 2027, followed by the transition period. For recent news and information from EUDAMED, click here. eu/tools/ eudamed. If Eudamed is not fully functional on time, then the registration deadline is 24 months after the date of publication of the OJEU notice about Eudamed functionality. Recently, the Commission updated its full implementation timeline for the database to account for this. manufacturers). Jan 26, 2024 · For more about the current EUDAMED timeline, visit our updated timeline blog. Firstly the EUDAMED (version 1) development will end in Q4 2023. EUDAMED—the European Database on Medical Devices—is an online electronic system that has been put in place by the European Commission (EC) to facilitate the regulation of medical devices and in vitro diagnostics (IVDs) throughout the European Union (EU) single market. The new target date for full functionality is now Q2 2027. It will include various electronic systems with information about medical devices and the respective companies (e. 81 8. Technical considerations and guidance for managing UDI data to meet the deadline. 1 min read. This guide consolidates timeline information and device class requirements across multiple regions, including the US, EU, China, Japan, Brazil, Australia, Canada, India, Saudi Arabia, Singapore, Taiwan Jan 24, 2024 · But the database has suffered a number of development delays; to date, three modules are live and functioning on a voluntary basis, two are nearly ready, and the development team is struggling with the sixth, the clinical module. COM(2024) 43 final. EUDAMED stands for EUropean DAtabase on MEdical Apr 16, 2019 · The publications center on the Eudamed database that will aid enforcement of the safety and performance requirements of the incoming regulations. Where the previous EUDAMED timeline showed mandatory use starting in Q2 2029, the new timeline shows the mandatory use of the Device Registration and Unique Device Identification (UDI) module starting from Q1 2026. ; Launching the second and third modules continues the roll-out of the database, which was supposed to be ready by the original Medical Device Regulation date of application in 2020 but is now subject to a delayed, staggered launch. The EUDAMED is currently under development. Dec 7, 2020 · The long-awaited EUDAMED database is finally beginning to become reality with the first module on Actor registration released on December 1st. The EUDAMED project aims to address the effective implementation of this provision of the Directives. Each user may have multiple accounts but can access EUDAMED with only one account at a time. Currently, EUDAMED is only partially ready, which has led to much confusion around the EU medical device community with what manufacturers need to do—and when—to meet EU MDR and IVDR requirements for EUDAMED. The system consists of: - a restricted website (Webgate) for database content management with access to all data Digital Solutions. Figure 1. Each EUDAMED account is associated with one of the following actors: • Manufacturer • Authorised Representative • System/Procedure Pack Producer • Importer Each of these actors has a set of roles that are specific to each module in EUDAMED. At the time they were a little strange however in 2024 the European Commission submitted an IDV proposal to the European Parliament. Jan 24, 2024 · The commission proposed the new timelines, which will now go to the European Parliament and Council for adoption, alongside plans to speed up the launch of parts of the Eudamed database that are already finalized, with a view to making use of the modules mandatory from late 2025. Nonetheless, as The European Commission has published new timelines related to EUDAMED. ” Article 33 of both regulations outlines “the setting up, maintenance and European Database on Medical Devices (Europäische Datenbank für Medizinprodukte, EUDAMED) Angehörige der Gesundheitsberufe (Healthcare Professionals, HCP) und The information in EUDAMED is primarily intended for the identification and localization of relevant actors and devices, and to provide an understanding of risks from the perspective of the population involved. Of note, it remains uncertain whether EUDAMED modules will have a staggered release. To that end, the surveillance and vigilance of this sector are key. According to paragraph 2 of those According to paragraph 2 of those Articles, Eudamed will be composed of six different electronic systems (so called modules), which facilitate the collation and processing of Jan 24, 2022 · As far as we are aware at present, EUDAMED will be available at the end of 2022. Instead, the registration should be modified as needed. Nonetheless, as Jul 6, 2022 · The European Commission (EC) published their EUDAMED timelines but what do they mean for me? EUDAMED Development and Audit. 1 EUDAMED Minimum Viable Product (MVP) means that the system developed implements at least the minimum Medical Devices Regulations requirements and allows competent authorities and all stakeholders to comply with their legal obligations. Feb 1, 2022 · The EC projects that EUDAMED will be fully functional by Q2 2023; and at that time the 24 month transitional period will begin. 83 7. Originally scheduled to launch in 2020, the database, a key part of the new regulations, suffered delays and is now in a staggered rollout. Using this new database is mandatory for medical device manufacturers, authorised Jan 23, 2024 · EUROPEAN COMMISSION. Dec 2, 2021 · Piece by piece, the Eudamed database and its supporting documentation are slowly coming together. EUDAMED registered users. Its primary purpose is to enhance market transparency and oversight in the medical device field by providing a comprehensive repository of information on medical devices and their respective manufacturers active within the EU. Oct 30, 2023 · EUDAMED is coming… In late October 2023, the European Commission published ‘draft’ EUDAMED timelines. Infographic: Users access requests Nov 3, 2023 · Recent Updates to the EUDAMED Timeline. On 23 January 2024, the European Union published the latest regulation, “amending Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] as regards a gradual roll-out of Eudamed [European Database on Medical Devices], information obligation in case of interruption of supply and transitional provisions for The European Database on Medical Devices (EUDAMED) and the Eudamed Timeline All parties operating under the provisions of the MDR and IVDR will have some level of responsibility in relation to use of Eudamed. The new launch date for Eudamed coincides with the implementation date for the In Vitro Diagnostic Regulation, set to take effect May 26, 2022. If you have UDI questions, we can help. It is similar to other public government databases, such as the US FDA’s database, which contains all registered Establishments, 510(k)s and pre-market approvals, device listings, adverse events/recalls, clinical investigation data, and more. FAQ of the EU MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED Why EUMEDIQ: EUMEDIQ’s experience, resources, communication skills, reputation, comprehensives services, and make location excellent choice for Authorized Representative. . What is EUDAMED? The European Database on Medical Devices (EUDAMED) is an online electronic system that has been put in place by the European Commission (EC) to facilitate the regulation of medical devices and in vitro diagnostics (IVDs) throughout the European Union (EU) single market. 3 on EUDAMED data reporting template and D4. 2 BACKGROUND In EUnetHTA JA3, 27 JCA/CA of medical devices or diagnostics were conducted. 📋 Development is Nov 30, 2023 · EUDAMED and all you need to know. Aug 19, 2020 · Revised timelines reflect MDR and EUDAMED implementation delays. The central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation – including a detailed FAQ section and a library of all platform user guides. * EC는 EUDAMED의 6개의 모듈이 모두 기능하는 기간을 2024년 2분기로 예정하였습니다. REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. EUDAMED consists of a total of six modules related to the following: actor registration, Jul 14, 2022 · According to its newly announced timeline, it will complete development of all Eudamed modules by the end of 2023. Apr 15, 2019 · the obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of MDR EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. An important aspect of the medical devices sector is to guarantee the safety of the products. 7. This delays EUDAMED by another year. Guidance for EUDAMED-based Topic identification, selection and prioritisation (TISP) process. The following are the most recent updates to the EUDAMED timeline: The European Commission is evaluating the development roadmap for EUDAMED. An auditing period will follow in 2024, and use of the database will become mandatory for IVD makers for clinical investigation, performance study, and market surveillance by the end of that year. Following the end of the development, a regulation mandated audit of EUDAMED happens in Q1 2024 with the MDCG sign off in Q2 2024. europa. 2024/0021(COD) Proposal for a. Aug 6, 2024 · When the database becomes operational, the following timeline is expected. In accordance with the new rules, any manufacturer shall thus assign a unique UDI to a device and to all higher levels of packag - Oct 6, 2021 · On 4 October 2021, the European Commission announced the successful launch of the EUDAMED UDI & Devices registration and the Notified Bodies & Certificates modules (Production release of “v2. The legislation requires manufacturers to assign all devices, with the exception of custom products, a unique identifier and provide it to a centralized database before bringing them to market. The new UDI Helpdesk is live. Search & View historical versions of Devices, Systems and Procedure Packs . The new draft timeline indicates that: All six modules will not be ready to undergo an independent audit until Q4 2026 Aug 8, 2019 · EUDAMED is the Database on Medical Devices in the Europe. The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. The Commission made another two Eudamed modules, on UDI/device registration and Notified Bodies and Certificates, available for voluntary use in October. […] Here you will find a compilation of websites on which the EU Commission provides information on the European regulations 2017/745 (MDR) and 2017 /746 (IVDR), on current topics in the European medical device sector, and specifically on the European medical device database EUDAMED. Following are the common elements between GUDID and EUDAMED but they likely need to be translated into 24 official languages of the EU: Name or Trade name devices (IVDR)2 requires the Commission to set up a European database on medical devices (Eudamed). Feb 1, 2024 · The MDR and IVDR amendment proposal, adopted by the European Commission on 23 January 2024, would allow earlier mandatory use of individual modules of the of European medical devices database ‘EUDAMED’ ahead of the timelines currently published. Dec 16, 2022 · Updated Timeline - Current planning for gradual roll out and modules’ functionality view. The EU Commission has recently announced that the timeline for completing and implementing EUDAMED has shifted again. We recognise the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. This extension is due to a number of factors, including the complexity of the project, the need to ensure data quality and security, and the impact of the Jul 12, 2022 · On July 6th, 2022, the European Commission released an updated version of the EUDAMED timeline. A major change for both economic operators and EU Member States is the obligation for central registration of vigilance information within the European database EUDAMED (MDR Article 8792, IVDR Article 87). Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. Of note are the revised timetables featured in this FAQ. For further information on EUDAMED, please visit the medical devices section of the European Commission website. Eudamed shall be accessible through machine-to-machine data exchange services to competent authorities as referred to in Article 101 of Regulation (EU) 2017/745 and Article 96 of Regulation EU 2017/746 (‘competent authorities’) and notified bodies registered in Eudamed in accordance with Article 3 of this Regulation. 더불어, 올해 EC 발표를 통해, 기간의 기약 없이 database의 모든 기능이 작동할 때 launching을 진행할 것이라 공표하였으며, 이번에 해당 timeline을 발표하였습니다. Q2 2024 Independent audit will be complete (Q1-Q2 2024) and the system will be fully operational. EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. There is the EU guidance on practices in the transition to fully availability of EUDAMED for MDR and IVDR (MDCG 2021-1, MDCG 2022-12). Nonetheless, as Jan 24, 2024 · The body also said the integrity of the EUDAMED database and its practical implementation are essential for ensuring the success of a mandatory EUDAMED. 2024. News announcement 10 July 2024 Directorate-General for Health and Food Safety 1 min read. a. ’ Therefore, EUDAMED should be continually updated and maintain current Jan 23, 2024 · to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro MDCG 2019-4 Timelines for registration of device data elements in EUDAMED Document date: Sun Apr 14 00:00:00 CEST 2019 - Created by GROW. In […] Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. According to the European Union, the development of the EUDAMED modules should soon come to an end. In accordance with the new rules, any manufacturer shall thus assign a unique UDI to a device and to all higher levels of packag - Oct 12, 2021 · Dive Brief: The European Commission has made Eudamed database modules on UDI/device registration and Certificates and Notified Bodies available for voluntary use. Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. The Actor registration module enables economic Jun 24, 2022 · The European Database for Medical Devices, or EUDAMED, is intended to store and provide information on the manufacture, distribution, certification, and post-market surveillance of devices. Once Eudamed is fully functional, this will become the mandatory registration system. In addition to incorporating the postponement of MDR implementation until 2021, the updated document also reflects the implementation delay of EUDAMED, the EU medical devices database, which was announced in October 2019. Jun 23, 2021 · The medical devices database, EUDAMED, is set to provide an overview of all medical devices available in the European Union. The corresponding publication in the Official Journal of the European Union (OJEU) will mark the date by when deadlines for an obligatory use of the corresponding modules will become applicable. Overview of EUDAMED Requirements. 4 - Publication date: Mon Apr 15 09:00:34 CEST 2019 - Last update: Mon Apr 15 09:01:03 CEST 2019 MDR EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The ‘end of 2022’ date is in line with the EU Commission’s new Timeline chart, which shows all six modules as being released by Q4 2022. This leads to the question: Is EUDAMED being further delayed? Find below: Last timeline published by the EU Commission; MedTech Insight Article Highlights; EUDAMED Working Group – 29 June 2023 Meeting Minutes This Project Plan describes the objectives, approach and timelines for the deliverable D4. This means that Economic Operators and Notified Bodies can start entering data on a voluntary basis into the European database on medical devices. EUDAMED submissions become mandatory after the 24 month transitional period, which is estimated to end in Q2 2025. CLick this link to view and search the EMDN. 3 MDR EUDAMED information system/database (1 database with 2 websites: Webgate and Europa) Central system on medical devices and in vitro diagnostic medical devices containing the modules stated in the section 3 Project Overview. Download Devices and System or Procedure Packs Mar 22, 2023 · ─ Q2 2026 (24 months after the OJEU publication) – the use of EUDAMED becomes mandatory in terms of requirements related to the UDI & Device and NB & Certificates modules. Eudamed’s functionality and implementation timelines have been somewhat unclear, following delays in the rollout of the different modules. EUDAMED will contain a living picture of the lifecycle of all products being available on the EU market. Note that EUDAMED is designed to serve as ‘a living picture of the lifecycle of medical devices that are made available in the European Union (EU). Regulation (EU) 2024/1860 establishes the rules for the registration of legacy devices in This site uses cookies. EUDAMED transition period. The obligation for placing the UDI carrier applies according to the following timelines: Nov 14, 2023 · The European Commission has announced a revised timeline for the development of EUDAMED, the European Union Medical Device Database. As the first step, EUDAMED must pass an independent audit and be deemed fully functional. However, it is not only used to manage medical devices. Jul 15, 2024 · EUDAMED Roll-out Amendment. Jul 11, 2022 · The European Commission is aiming to have a fully functional version of the Eudamed medical device database available in the second quarter of 2024. 8. The following information was provided during the Medical Devices Coordination Group (MDCG) EUDAMED WG meeting on 19 October: To register in EUDAMED, non-EU manufacturers must have an active authorised representative and submit a mandate summary document with their registration request. Brussels, 23. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. Registration of legacy devices. EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. It helps the economic operators to implement the requirements introduced by the unique device identification system. For more information on the EMDN, see also the EMDN Q&A. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. How do I register my devices on Eudamed? Economic operators must register the following devices using the Eudamed device registration module; Oct 10, 2021 · EUDAMED is the European Database on Medical Devices. Modules that are audited and declared functional can be gradually implemented as early as end of 2025. Jun 24, 2021 · The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). Update (October 2023): EUDAMED received another timeline update: a three-year extension Jul 12, 2024 · A quick history of the still incomplete EUDAMED database. Sep 14, 2020 · TIMELINE DELAY. 1. Considering the contingent situation the implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the Jul 30, 2024 · The central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation – including a detailed FAQ section and a library of all platform user guides. EUDAMED is expected to become fully functional by mid-2024. To stay up-to-date with EUDAMED development and timelines, please check the dedicated European Commission webpage. On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database. News announcement. Search and View historical versions of Devices and System or Procedure Packs . Jun 28, 2021 · Die Europäische Kommission hat am 26. May 2, 2019 · This 18-month registration timeline applies if the new database is fully functional by 25 March 2020.
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