What is eudamed

What is eudamed. Eudamed has been in existence for many years but only accessible by the European Commission and the National Competent Authorities. eu. Although EUDAMED will not be mandatory until two years from the date it is fully functional if you are an Economic Operators (EU and non-EU Manufacturers, Authorized Representatives, system manufacturers, and medical devices and in-vitro diagnostic medical devices importers) it is recommended that you complete your registration in the system to receive your Eudamed: european database of medical devices. What does the EU MDR require for the new EUDAMED system? EUDAMED. EUDAMED Database Structure. The EU Commission provides extensive information on its websites in various places and is the contact for all questions related to EUDAMED. The purpose of Eudamed is to improve transparency and coordination regarding medical devices available on the EU market. MDR-Eudamed is the official landing page for the EU database of medical devices. Jun 23, 2022 · The main purpose of the EUDAMED database is to enhance traceability, cooperation, and transparency regarding medical devices in EU. An authorised representative will have to cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities In the guidance document MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional, the Medical Device Coordination Group (MDCG) sets out how to apply certain provisions of the MDR that require the use of Eudamed. The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. needed to find the SSCP in EUDAMED; value of the Basic UDI-DI or another metadata can be stated, provided it can be used to unambiguously search and find the intended SSCP in EUDAMED. EUDAMED is a centralized European database used to collect information about medical devices and their manufacturers. The EUDAMED database will safely store this information in a standardized format. Manufacturers must register both themselves and their devices into EUDAMED; however, only Economic Operators (Manufacturers, Distributors, Importers and Authorized Representatives) can currently register in EUDAMED to obtain what is referred to May 17, 2021 · The timelines approach quickly and UDI team preparation is no easy task. Despite the fact that the Actors registration module on EUDAMED is operational, economic operators should be aware that the MDR’s requirements for EUDAMED will not take effect until six months after the Commission has given notice under Article 34(3) that the database is fully operational. It’s a comprehensive online database that aims to help promote patient safety through increased transparency of both medical devices currently sold on the EU market and those that will be placed on the EU market in the future. EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. 1. Registration of legacy devices. It aims to enhance transparency about medical devices, including better access to information for the public and healthcare professionals, and enhancing coordination 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 A central theme running throughout the updated EUDAMED is increased transparency of data on medical device performance. It is the unique database of medical devices and it is intended to collect all the data about the medical devices on the European market. Jul 17, 2024 · EUDAMED medical device and IVD registrations do not expire. Dec 16, 2022 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Jan 25, 2022 · EUDAMED aims to visualize the life cycle of medical devices made in the European Union (EU) and available on the European market. It is generated through the EUDAMED system after your registration there is validated by the relevant Competent Authority and (if applicable) your Authorized Representative. EUDAMED EUDAMED EUDAMED EUDAMED European database on medical devices EUDAMED ID What is a EUDAMED ID? EUDAMED ID & UDI˜DI What are the di˚erences between EUDAMED ID and UDI-DI? EUDAMED DI What is a EUDAMED DI? STRUCTURE SAMPLE What is the structure in EUDAMED? The EUDAMED DI corresponds to the Basic UDI-DI. This post summarizes the general principles and the main Sep 22, 2020 · Eudamed is an IT system developed by the EC to implement medical device and in vitro diagnostic (IVD) medical device regulation (EU Regulation 2017/745 and EU Regulation 2017/746, respectively). The national competent authorities from EU 27, Iceland, Liechtenstein, Norway and Turkey are registered in EUDAMED as well as the UK competent authorities in respect of Northern Ireland. independent audit, publication of notices of functionality) of EUDAMED will remain unchanged. This was the first of the six EUDAMED modules to be made available. 29-31 p. Eudamed 2 has been processing device, certificates, NCARs and clinical investigations data for many years. 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. Feb 20, 2024 · What is EUDAMED? EUDAMED is a comprehensive, centralized digital platform designed to store and maintain key information about medical devices circulating in the EU market. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional; MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States; MDCG 2019-5 Registration of legacy devices in EUDAMED Jul 11, 2022 · Eudamed had been scheduled to go live in May 2020, the original date of application for the Medical Devices Regulation. Contact: SANTE-EUDAMED-SUPPORT@ec. g. EUDAMED will be made up of 6 modules (of which, not all are currently available) and will be used for different purposes as shown in the table below. The purpose is to increase transparency, including providing better access to information for the general public and healthcare professionals, as well as improving collaboration between different EU countries. For more information on the EMDN, see also the EMDN Q&A. Instead, the registration should be modified as needed. For the most current understanding of EUDAMED’s deadlines, please read: EUDAMED Gradual Rollout (starting 2025) Until EUDAMED is mandatory, the registration requirements under the old Directives (MDD/AIMDD/IVDD) continue to apply. These regulations affect the work of manufacturers and also the work of authorities and notified bodies. Firstly the EUDAMED (version 1) development will end in Q4 2023. Bulk EUDAMED UDI DI Search Importers, Authorised representatives, distributors, and manufacturers “Eudamed Check” is a service to save you time and money when searching EUDAMED for UDI DIs. ’ Therefore, EUDAMED should be continually updated and maintain current Apr 17, 2022 · Under the Regulation, Member States of the EU must ensure that device information is uploaded properly, including UDI and labeling information. EU-DA-MED European Database on Medical Devices 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/ Aug 13, 2024 · A Single Registration Number is a unique identifier generated by EUDAMED that is issued to medical device legal Manufacturers, Authorized Representatives, and Importers involved in placing medical devices and IVDs on the European market following approval by the competent authority. By vigilance, the Medical Device Regulation (MDR) refers to the monitoring and reporting system of medical devices. 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. Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Access the modules, public website, and information centre of EUDAMED. If you are linked to only one actor registered or you have already selected the actor and accessed the dashboard, click on the link with your name (top right corner) → scroll Oct 20, 2023 · Eudamed will provide an overview of the lifecycle of medical devices available on the market in the EU. How Does EUDAMED Work? Shared Responsibility EUDAMED is owned by the EU Commission, however, the relevant stakeholders are obliged to make complete and accurate data available in the necessary modules to be compliant to EU MDR. It is part of the EUDAMED vigilance system. Sign in to EUDAMED EUDAMED is an IT system by the European Commission to implement Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. 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. Keywords: MDR, IVDR, EUDAMED, Modules, ACT, UDI, CRF, CIPS, VGL, MSU What is EUDAMED? The EUDAMED stands for “European Database for Medical Devices” and is operated by the European Commission to centralize all relevant information on medical devices on the EU market and to ensure traceability and transparency. Mar 8, 2022 · EUDAMED is a new European system for medical devices that aims to put all aspects of registering, monitoring, and managing information about products among different industry actors. For this reason, the MDR requires that the EUDAMED system be updated to be accessible to the public and to the medical device industry as a whole. The EUDAMED post-market surveillance module (short: PMS) is self-explanatory. Stay up-to-date with the latest news and developments on EUDAMED and the impact it will have on medical device manufacturers, healthcare professionals and healthcare institutes. Jan 24, 2022 · Originally, EUDAMED was to be fully functional on 26 May 2020, to align with the MDR’s original date of application. We recognise the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. What is EUDAMED? Eudamed was introduced with the text of Regulation (EU) 2017/745 on medical devices, that became fully applicable on 26 May 2021. The Required product data will be submitted to EUDAMED, i. To register in EUDAMED, non-EU manufacturers must have an active authorised representative and submit a mandate summary document with their registration request. What is the EUDAMED? The European Database on Medical Devices (EUDAMED) is a secure, web-based portal designed to enhance public health and patient safety by providing a central repository for information on medical devices and operators (manufacturers, authorized representatives, importers, and distributors) available on the EU market. What is EUDAMED? The European Database on Medical Devices EUDAMED is the IT system developed by the European Commission as an integral part of MDR and IVDR implementation. Fortunately, this provides sufficient time for medical device companies to consider EUDAMED’s impact on their IP strategy and implement policies and processes EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and good practices, and therefore, it is not because something is possible in EUDAMED that it is necessarily allowed. Stakeholders responsible for updating product information in EUDAMED include: I’m an HCP (or a patient) Economic EUDAMED Definition. . Jul 2, 2024 · An updated timeline for the mandatory implementation and use of the European Database on Medical Devices (EUDAMED) is now available. A comprehensive overview is provided by the EUDAMED information center of the EU Commission: EUDAMED EUDAMED EUDAMED EUDAMED European database on medical devices EUDAMED ID What is a EUDAMED ID? EUDAMED ID & UDI˜DI What are the di˚erences between EUDAMED ID and UDI-DI? EUDAMED DI What is a EUDAMED DI? STRUCTURE SAMPLE What is the structure in EUDAMED? The EUDAMED DI corresponds to the Basic UDI-DI. Aug 28, 2023 · What is EUDAMED? EUDAMED is the European Commission’s Medical Device and In Vitro Device Database. ACTORS INVOLVED? EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and good practices, and therefore, it is not because something is possible in EUDAMED that it is necessarily allowed. It improves transparency and coordination of information about those Medical Devices. The procedural aspects for the declaration of functionality of the modules (e. A system or a procedure pack that is a device in itself has to be registered by a Manufacturer (MF) and is not considered as a system or procedure pack to be registered by a System/Procedure pack producer (PR). EUDAMED supports the transparency and traceability of medical devices, which is vital for ensuring public health and safety. 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 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. The new EUDAMED database will include information on UDIs, the registration of economic operators (except for distributors) and devices, certificates, clinical and performance investigations, The manufacturer registers in EUDAMED both their company details, as an economic operator (See Article 31), and their devices’ details (See Article 29). Learn more about EUDAMED device registration, UDI submissions and BUDI-DI requirements from the industry experts at Reed Tech. EUDAMED is the European medical device database. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. To summarize, EUDAMED is a key component of the European medical device regulatory framework, acting as central hub of information for all stakeholders. EUDAMED’s main goal is Jan 15, 2024 · Eudamed is the information system developed by the European Commission to implement Regulation (EU) 2017/745 regarding medical devices. However, it is not only used to manage medical devices. Jun 24, 2021 · EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). the EU regulatory database for regulated medical devices. The System/Procedure pack producer (PR) is responsible for the registration of System/Procedure packs in EUDAMED. Which national competent authorities will be registered in EUDAMED Actor module. 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. The EMDN is fully available in the EUDAMED public site. Mar 14, 2022 · The EUDAMED Actor Registration module launched on 1 December 2020. It will integrate different electronic systems to collate and process information about medical devices and related companies (e. The EU MDR is intended to be a regulatory framework for medical devices that can sustainably ensure health & safety while still encouraging innovation. 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). It can either be entirely generated by 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). europa. EUDAMED is the European Database on Medical Devices 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. Templates – we have completed the hard work for you, we created MDR, MDD, SPP, IVDR, and IVDD, templates for your EUDAMED Device data preparation. What is EUDAMED The UDI-DI/Device module of EUDAMED is used for this purpose. applies 24 months after EUDAMED has become fully functional) However, manufacturers will be in a position to voluntarily comply with registration obligations as from 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices. Sep 25, 2020 · EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. 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. The development of the module for Clinical Investigation and Performance Studies (CI/PS) will take longer than expected. How do I register my devices on Eudamed? Economic operators must register the following devices using the Eudamed device registration module; Nov 30, 2023 · EUDAMED and all you need to know. Jul 25, 2024 · Eudamed is the European Database on Medical Devices. Required Actions. Regulation (EU) 2024/1860 establishes the rules for the registration of legacy devices in This site uses cookies. EUDAMED transition period. The European Commission plans for the various modules of Eudamed to be made available gradually, with full deployment scheduled for the second quarter of 2027 . It can either be entirely generated by Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. Preparing early with a data strategy will make all the difference when mandates for EUDAMED and other health authorities come due. This is core to the MDR and IVDR regulations. 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. 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. Apr 22, 2019 · EUDAMED is the European Database on Medical Devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. This secure, web-based portal will act as an interpretable registration, collaboration, reporting, and dissemination system accessible to the public. May 2, 2021 · In addition, authorised representatives will have to verify that the manufacturer has registered the requested information in EUDAMED (MDR/IVDR Article 11(3)(c)). It was designed with the intent to strengthen market surveillance and transparency with regard to medical devices in the EU market. EUDAMED registered users. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. Documentation →. Get started using the EUDAMED platform, learn the basics. If the manufacturer is an EU based company that is the all. e. 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. The EUDAMED system is currently in development, and according to revised timelines published by the European Commission, mandatory use of EUDAMED is not expected to commence until 2024. EUDAMED would then become mandatory on 26 May 2022, after a two-year transition period. Actor →. This will allow the mandatory use of several modules to start from end 2025. EUDAMED will contain a living picture of the lifecycle of all products being available on the EU market. EUDAMED is the database of Medical Devices available on the EU Market. EUDAMED was originally scheduled to be fully functional by May 26, 2020. The EMDN is the nomenclature to be used by manufacturers when registering their medical devices in EUDAMED. The new date of EUDAMED’s full functionality is Q2 of 2027. Sep 19, 2018 · MDR Eudamed is the new European Databank on Medical Devices. 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 full EUDAMED system integrates six modules: Oct 17, 2021 · Economic Operator Registration. When an actor is registered in EUDAMED, everyone who intends to act on behalf of this actor needs to submit an access request. It shall be noted that, provided that Eudamed is fully functional, Oct 19, 2023 · This regulatory framework is intended to better identify medical devices, as well as standardizing data and technological advances through an EU database (EUDAMED). Oct 3, 2022 · What is EUDAMED? EUDAMED is meant to be a living record of the lifecycle of medical devices which are sold in the EU. According to criteria and requirements set out by the European Commission and EU regulators in the Medical Device Coordination Group (MDCG) and based on orientations provided by the MDCG, the EMDN was founded following a European Commission notice indicating the utilisation of the Italian Ministry’s Classificazione Nazionale Dispositivi medici (CND) as the basis for the future EMDN. This is a database that monitors the safety and performance of medical devices. implementation of EUDAMED modules as soon as they have been audited and declared functional. The EUDAMED is currently under development. Getting Started →. MDR 2017/745 further states that 'Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, Mar 1, 2022 · The EUDAMED UDI/device registration module is a centralized EUDAMED database that contains information about every medical device with a UDI that is placed on the market in Europe. For the most current understanding of EUDAMED’s deadlines, please read: EUDAMED Gradual Rollout (starting 2025) Oct 14, 2021 · Countries available in EUDAMED. How does EUDAMED check for duplicate actors, and will this prevent me from creating more than one actor role for my organisation? A: The duplicate check is performed on certain fields (name, address, VAT, EORI) for each separate Actor type, so an Actor registering a second time with the same name and address but for another actor type will not Mar 5, 2024 · What is EUDAMED? EU-DA-MED European Database on Medical Devices The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices WHAT IS EUDAMED? EUDAMED is an information system that was established by the Regulation (EU) 2017/745 on medical devices and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and developed by the European Commission. Information about EUDAMED on the websites of the EU Commission Overview. Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional: May 2021: MDCG 2020-15: 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 Jul 17, 2024 · EUDAMED is currently voluntary; its mandatory use date has been postponed. manufacturers). EUDAMED registration is a requirement of the EU Medical Device Regulation MDR 2017/745 (art. Understanding what is EUDAMED, how it operates, and the steps involved in EUDAMED registration is crucial for medical device manufacturers who wish to operate within the EU. Dates which are much more important for you as a future user of the EUDAMED: What is EUDAMED? The European Databank on Medical Devices (EUDAMED) is an IT system developed by the European Commission to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the European Union. The aim is to provide an updated picture of the life cycle of devices available in the European Union (EU). Each user may have multiple accounts but can access EUDAMED with only one account at a time. Once Eudamed is fully functional, this will become the mandatory registration system. 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. The database is huge and has been split up into six different modules with specific purposes. What is EUDAMED? EUDAMED is a secure web application used to capture and share data related to medical devices placed on the EU Market. EUDAMED is designed to enhance transparency, traceability, and safety in the medical device industry. Jun 28, 2022 · A BUDI-DI is the key that unlocks the EUDAMED and provides access to all of the product information. Infographic: Users access requests Aug 30, 2023 · EUDAMED is the European database for medical devices. 4) and the EU Jul 6, 2022 · The European Commission (EC) published their EUDAMED timelines but what do they mean for me? EUDAMED Development and Audit. EUDAMED is expected to become fully functional by mid-2024. One primary difference between the UDI GUDID and the UDI EUDAMED requirements is family product grouping called Basic If you are linked to more than one Actor, on the My Actors page, which is your homepage when accessing EUDAMED, click on the See my pending Requests link (bottom left). It’s the primary identifier of the device group/family; It’s the main record key in the EUDAMED; It’s the main product identifier in the regulatory documentation; It’s independent of packaging and labeling; UDI issuing agencies Nov 3, 2023 · Recent Updates to the EUDAMED Timeline. Sep 25, 2023 · The European Medical Devices Regulation (EU MDR) has ushered in a new era of regulations for medical devices in the European Union. However, it has been postponed. Following the end of the development, a regulation mandated audit of EUDAMED happens in Q1 2024 with the MDCG sign off in Q2 2024. The following are the most recent updates to the EUDAMED timeline: The European Commission is evaluating the development roadmap for EUDAMED. EUDAMED received another timeline update: a three-year extension. For further information on EUDAMED, please visit the medical devices section of the European Commission website. Notified Bodies and Certificates : Medical devices must comply with safety and performance standards set out by the EUDAMED regulation. The SRN number is the number by which your company will be identified in the EUDAMED database and all official regulatory documents in the EU. Overview of EUDAMED Requirements. EUDAMED stands for EUropean DAtabase on MEdical EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market. Find out below who needs to register as a EUDAMED Actor. The system will be multipurpose. With the Medical Devices Regulations (MDR and IVDR), EUDAMED has been introduced to ensure traceability of the devices within the supply chain and strengthen market surveillance and transparency in the European Union. However, close to the May 2020 implementation date, the EU Commission delayed EUDAMED by two years. Apr 24, 2023 · EUDAMED serves as a central repository for medical device data, and thus individual actors in the healthcare space will need to establish communication with EUDAMED to ensure their data is received and aggregated in accordance with the new regulations. It’s use will be restricted to national competent authorities only and whilst it will disseminate some information to the general public, it won’t be fully accessible to them. Oct 10, 2021 · What exactly is EUDAMED? EUDAMED is the European Database on Medical Devices. The EU Regulations have introduced a new concept: the Basic UDI-DI, that aims at grouping regulated medical devices under the same identifier. 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. Late in 2019, the Commission delayed the launch by two years and then outlined a phased rollout, with the actor registration module going live in December 2020 followed by the modules for UDI/device registration and notified Dec 1, 2020 · Deadline to register in EUDAMED. Among its many requirements, one of the most significant changes is the establishment of the European Database on Medical Devices (EUDAMED). EUDAMED stands for the EUropean DAtabase on MEdical Devices. Aug 6, 2024 · What You Need to Know Already delayed by 4 years, the European Database on Medical Devices (EUDAMED), a European Union (EU) database considered to be the foundation of the EU medical device and in vitro diagnostic regulations (MDR and IVDR), now has an updated timeline for launch, according to the European Commission. User guides, technical documentation and release notes. EUDAMED stands for EUropean DAtabase on MEdical Aug 9, 2024 · MDCG 2021-1 Rev. The EUDAMED database aims to assist European authorities with the exchange of information on medical devices. EUDAMED is a key component of the MDR 2017/745 and IVDR 2017/746 regulations. bozuez bbvdj uevxpkot zvztdz zop nmkgiljt dbcq hsnlz mfbe vctpd