Eudamed database medical device

Eudamed database medical device. May 17, 2021 · EUDAMED is the IT database that stores and regulates medical devices in the European Union and industry activity is underway leading up to a full launch anticipated in May 2022. 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 UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their De asemenea pentru orice problemă/nelămurire întâmpinată vă recomandăm să utilizați adresa de e-mail de asistență EUDAMED: SANTE-EUDAMED-SUPPORT@ec. EUDAMED is the database of Medical Devices available on the EU Market. eu. Documentation →. Aug 9, 2024 · Guidance is also available from the Medical Device Coordination Group; on the European Medical Device Nomenclature (EMDN) MDCG 2024-2 Procedures for the updates of the EMDN. 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. . The EUDAMED database is similar to the FDA in the United States, however it requires more product data attributes and the concept of basic unique device identification One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies Once an economic operator has been validated by its Competent Authority and an Actor ID/SRN is issued, its details (except those only for the Competent Authority) become visible to all users in EUDAMED and will be publicly available on the EUDAMED public website. Apr 20, 2012 · 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. It is a collaborative, multiplatform These regulations emphasize the establishment of a comprehensive and versatile database known as the European Database for Medical Devices (EUDAMED). New features on the EUDAMED database will include systems for registration, collaboration, notification, and dissemination. Mar 1, 2022 · Everything You Need to Know About EUDAMED: Preparing for the New Medical Device Regulation. Unfortunately, you can’t access Eudamed. indexat în anul 2024, pentru validare/verificare înregistrare în Eudamed se percepe următorul tarif: The European Commission has published many artefacts relating to EUDAMED and the Medical Device and the In-Vitro Regulations (MDR/IVDR). 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. md_eudamed_fs_v7_2_en. 01. The FDA is establishing the unique device identification system to adequately identify devices sold in the U. EUDAMED is the European Database on medical devices. It is the primary means of identifying these so-called Dec 16, 2022 · Functional specifications for the European Database on Medical Devices (EUDAMED) 16 DECEMBER 2022. Oct 10, 2021 · EUDAMED is the European Database on Medical Devices. The database is called Integrated Medical Device Information System (IMDIS). 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 new EUDAMED database will be publicly available in 2020. Legacy devices are defined as medical devices, active implantable medical devices and in vitro 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. It aims to enhance transparency about medical devices, including better access to information for the public and healthcare professionals, and enhancing coordination The Actor ID/SRN is a EU-wide unique identification for economic operators in the medical devices sector. Jul 17, 2024 · Examples are: Class IIb implantable, Class III medical devices, Class C near patient testing IVD devices and Class D IVD devices. 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 interaction between the UDI system and the Eudamed database is evident: the UDI code acts as a key link between medical devices and the data stored in Eudamed. manufacturers). The system consists of: - a restricted website (Webgate) for database content management with access to all data The European Committee for Standardization (CEN) published CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and the European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. Dive Brief: The European Commission has posted an implementing regulation for the Eudamed medical device database, providing a framework for the basic operation of the system which is meant to meet the information exchange needs of the medtech sector in implementing the EU Medical Device and In Vitro Diagnostic Regulations. 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. 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. The development and implementation of this IT system is a high priority for the Commission. 12. 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. S. 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. EUDAMED is designed to enhance transparency, traceability, and safety in the medical device industry. 3467/2022, Anexa 1, pct. European regulatory guidance on Eudamed nomenclature requirements for medical devices and IVDs Nov 30, 2023 · EUDAMED and all you need to know. MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN). Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the Actor ID/SRN of the economic operator to the national competent authority and transfers it to the requesting economic Overview of EUDAMED Requirements. Jan 15, 2024 · USEFUL RESOURCES IN THE EUDAMED DATABASE. EUDAMED is the ‘European Database on Medical Devices’. To facilitate this requirement the European Commission (EC) is implementing a state-of-the-art database widely known as the European Database on Medical Devices (EUDAMED). Apr 17, 2022 · The European Union Database on Medical Device (EUDAMED) is a digital exchange for legal information on medical devices under the European Union Medical Device Regulation (EU MDR). Conform OMS nr. The system consists of: - a restricted website (Webgate) for database content management with access to all data 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). Aug 30, 2022 · There’s no need to let Eudamed full functionality delays stop you from searching for and finding medical device vigilance data in Europe. EMDN The EMDN – The nomenclature of use in EUDAMED. pdf. This site uses cookies. Do not miss our other articles relating to the medical device industry. A medical device (including system- and procedure packs and IVD) needs to have an assigned Basic UDI-DI and needs to be registered in the UDI/Device part of EUDAMED. Useful Information 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. EUDAMED aims to ensure a proper traceability level of the devices within the supply chain. Jan 29, 2014 · I had the pleasure of presenting at the Informa Conference on the Medical Devices Directives and the Revision in Brussels today. Jun 23, 2021 · The medical devices database, EUDAMED, is set to provide an overview of all medical devices available in the European Union. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). An nice conference with a good overview of what is coming our way in terms of EU medical devices regulation 2. The mandatory use of finalised parts of EUDAMED will support all key players in the implementation of the regulatory framework and enhance transparency for the public. This integration makes it easy to track and monitor every medical device throughout its lifecycle, from the supply chain to manufacturing to end use. The website is expected to be updated regularly upon new implementation documents are finalised. Get started using the EUDAMED platform, learn the basics. The regulation, known as MDR (Medical Device Regulation), replaces the Medical Devices Directive (MDD) and sets new standards for medical device registration and market Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices: February 2022: MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices: January 2022: MDCG 2021-7: Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro EUDAMED, an abbreviation of European Database on Medical Devices, is initiatives developed by European Commission. You just need to look for country-specific sources. GS1 has been accredited by Korean Authorities as issuing agency for Unique Device Identification (UDI). One of the tasks of the Medical Device Coordination Group (MDCG), established by the European Commission, is to provide a series of documents that help stakeholders to apply Regulation (EU) 2017/745 on medical devices (MDR). We request the following entities to register their economic operator and device details on Eudamed: Manufacturers (including manufacturers of Class III custom made medical devices) Importers, Authorised representatives, Non-EU manufacturers whose authorised representative is based in Ireland, System and procedure pack producers. 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. EUDAMED also contribute to the uniform application of the Directives. Feb 1, 2017 · Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. Overview of the different roles of economic operators: Table showing the definition in MDR and IVDR of different roles of an economic operator Aug 21, 2023 · The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). Its purpose is to strengthen market surveillance and transparency in medical device field providing to competent national authorities with quick access to information. Providing greater transparency for patients and HCPs is at the heart of the change. database encompassing class I medical devices entered in the register of medical devices after 1 July 2013 and medical devices and in vitro diagnostic medical devices for which HALMED received a notification of placing on the Croatian market after 1 July 2013, available for search via forms "Database search according to subjects (after 1 July A similar database is the Global Unique Device Identification Database (GUDID) of the FDA. Dec 10, 2023 · Eudamed is the new European database for medical devices, and its use is not mandatory yet. - from manufacturing through distribution to Regulation Devices are defined as medical devices and in vitro diagnostic medical devices that are placed on the market under Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR). Feb 29, 2024 · Eudamed: The European medical device database Eudamed is the basis for a large number of registration obligations. The system is comprised of six modules: Jan 24, 2024 · The Commission says the mandatory use of the European database on medical devices, EUDAMED, is key for the effective and efficient implementation of the Medical Device and IVD Regulations. It will include various electronic systems with information about medical devices and the respective companies (e. Its legal basis is outlined in Regulation (EU) 2017/745. The National IMDIS collects both medical device data and medical devices’ distribution (transaction) records. The European Committee for Standardization (CEN) published CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and the European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. In this article, you can read more about this database. For further information on EUDAMED, please visit the medical devices section of the European Commission website. The Medical Devices and the IVD Medical Devices Regulations introduced the requirement to register medical devices in a European database, EUDAMED. The new European Database on Medical Devices (EUDAMED) will power this Jun 6, 2019 · The European Commission has recently set up a new webpage to collect information that is related to the implementation of the upcoming European database on medical devices (EUDAMED). Getting Started →. 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. While some modules are already available, European The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries. The European Commission is made available the Actor Registration Module to Member States and economic operators on December 1, 2020. It improves transparency and coordination of information about those Medical Devices. The Medical Devices Directives establish specific procedures that the national authorities must follow when considering whether or not: a medical device is unsafe and should be withdrawn from the market ('safeguard clause') 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. Related articles: EUDAMED: European Database on Medical Devices; EU Device Coordination Group Offers EUDAMED Guidance; EUDAMED: European Commission Jun 23, 2022 · Bear in mind that this article covers only the information on EUDAMED login. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce a device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. Originally scheduled to launch in 2020, the database, a key part of the new regulations, suffered delays and is now in a staggered rollout. May 26, 2021 · Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED. If you want to know more about the European database on medical devices you can read the EUDAMED user guide. Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED). 58 MB - PDF) Dec 2, 2021 · MedTech industry news. The database is not yet fully functional and is considered complicated to use. eu 15 December 2022 Functional specifications for the European Database on Medical Devices (EUDAMED) - to be audited (only for Minimum Viable Product (MVP) Legal Priority) EUDAMED is an IT system developed by the European Commission to uphold Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on diagnostic medical devices. europa. This mandatory registration is expected to take effect as of late 2025. Die EU-Verordnung über Jan 25, 2022 · What is EUDAMED? EUDAMED – the European Database on Medical Devices – was launched to exchange information between the European Commission (EC) and national competent authorities. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they Jun 23, 2022 · The main purpose of the EUDAMED database is to enhance traceability, cooperation, and transparency regarding medical devices in EU. The databases presented above can help you build an evidence-backed risk profile of your device, equivalent device or the competitors’ devices in Europe. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of adverse events in Europe. MedTech Europe acknowledges the European Commission proposal for extending the In Vitro Diagnostic Medical Devices Regulation (IVDR) transitional periods, and – for both the IVD Regulation and Medical Devices Regulation – allowing for early mandatory use of European medical devices database (EUDAMED) modules and requiring notification of device discontinuations. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. 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. To search and view actors: Apr 22, 2019 · EUDAMED is the European Database on Medical Devices. 2. It will increase transparency in the EU, providing an overview of all medical devices available on the European market. Aug 30, 2023 · EUDAMED is the European database for medical devices. EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. Actor →. Everything to everyone My subject was the Eudamed database under the revision project… May 30, 2024 · The new regulation also enables a gradual roll-out of the European database on medical devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. The Basic UDI-DI is the main key in the database and relevant documentation (e. User guides, technical documentation and release notes. If you want to learn more about the whole database, check out this article. The EUDAMED system is intended to be multipurpose, and will function as a registration system, a 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. 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. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes: (a) to enable the public to be adequately informed about devices placedon the market, the corresponding certificates issued by notified bodies and about the […] AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, Global Medical Device devices (IVDR)2 requires the Commission to set up a European database on medical devices (Eudamed). Dec 16, 2022 · Functional specifications for the European Database on Medical Devices (EUDAMED) 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). As part of the new MDR, the European Commission developed a secure database called EUDAMED to improve transparency and coordination of information regarding medical devices on the EU market. Feb 21, 2024 · Gradual roll-out of EUDAMED. 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 21, 2021 · The European Commission has clarified requirements pertaining to nomenclature medical device manufacturers will use to enter their product information into the forthcoming Eudamed database. g. Oct 3, 2022 · To accomplish this goal, the regulations call for a multipurpose database known as the European Database for Medical Devices (EUDAMED). For those above mentioned risk class devices, the registration will be auto-routed to the Notified Body for confirmation, before it can be published in the EUDAMED database. As a key to Eudamed, the MDR introduces the Basic UDI-DI as unique device identifier. Here are some link to better understand UDI and EUDAMED Document Short summary Author […] Jul 4, 2024 · In addition, EUDAMED– the new European database for medical devices and in vitro diagnostic medical devices – will play a central role in making basic data widely available, and in reporting and tracking incidents. Medical EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medical Products and Innovation Devices Contact: SANTE-EUDAMED-ADMINISTRATOR@ec. 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. EUDAMED will contain a living picture of the lifecycle of all products being available on the EU market. Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. It primary purpose to enhance market transparency and oversight in medical device field by providing comprehensive repository of information on medical devices and their respective manufacturers active within the EU. 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. Jan 23, 2024 · In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). The Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish an EU system for the identification of devices based on the unique device identifier (UDI), improving traceability of medical devices. The system is comprised of six modules: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). We can help with our exclusive EUDAMED training, this medical device database requirements are complex, let us help you gain a clear understanding of what you need to do. 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 Registration is a European Database an IT system proposed by the European Commission for medical devices and in-vitro diagnostic devices to meet certain requirements mentioned in regulations EU MDR 2017/745 and EU IVDR 2017/746, respectively. The links to the regulations are below, these links are to the searchable texts and the pdf documents. The module on UDI database & device registration (second module) and the module on Certificates and Notified Bodies (third module) are available since October 2021, except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP One of the new requirements is that Medical Devices (MDs) should be traceable through the entire supply chain, thus, from the manufacturer to the end user. a database that will contain information about all medical devices and IVDs placed on the EU market. It is being developed in accordance with functional specifications drawn up by the Commission in collaboration Nov 27, 2020 · It will replace the Eudamed2 database currently in place under the Medical Device Directives. 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. The EU Medical Devices Regulation (EU MDR) will ensure a robust, transparent, and sustainable regulatory framework and maintain high levels of safety for people living in the EU. 2024. English (1. EUDAMED is the EU medical device database that came into effect in May 2021. The database is huge and has been split up into six different modules with specific purposes. Among its many requirements, one of the most significant changes is the establishment of the European Database on Medical Devices (EUDAMED). However, it is not only used to manage medical devices. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. 5 days ago · 1. The second module "Devices" will go live in several phases: after the first release in 2025, it will be possible to register certain devices 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. Among its various uses, it will be utilised by European Database on Medical Devices (Europäische Datenbank für Medizinprodukte, EUDAMED) Angehörige der Gesundheitsberufe (Healthcare Professionals, HCP) und Patienten haben nach der Einführung der neuen europäischen Gesetzgebung Zugang zu mehr Informationen über Medizinprodukte. What is EUDAMED Jul 10, 2019 · Article 33 European database on medical devices 1. EUDAMED aims to provide a living picture of the medical device lifecycle and make it available to the European Union (EU). The EUDAMED system integrates six modules to collate and process the information on medical devices and manufacturers: Actors Registration; Unique Device Identification (UDI) and Device Registration EUDAMED database – European Database on Medical Devices, is the IT system engineered by European Commission to put into effect Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic devices. In accordance with 21 CFR Part 803, manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or As part of the new IVDR, the European Commission developed a secure database called EUDAMED to improve transparency and coordination of information regarding medical devices on the EU market. EUDAMED European Database of Medical Devices FSCA Field Safety Corrective Action IFU Instructions For Use MDR Medical Devices Regulation (EU MDR 2017/745) MDCG Medical Devices Coordination Group NB Notified Body PMCF Post-Market Clinical Follow-up PMS Post-Market Surveillance PMSP Post-Market Surveillance Plan PMSR Post-Market Surveillance Report In addition, the regulation introduced the establishment of an EU database on medical devices (EUDAMED) and Unique Device Identification numbers for device traceability. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) and will also be the access key for device-related information entered in future European medical device database. When EUDAMED is fully functional, manufacturers will have to enter In order to preserve equivalence between the Swiss and EU regulations and minimise the effort for economic operators, swissdamed resembles the corresponding modules of the European database EUDAMED. 0 - or not. 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. Although the EUDAMED database was set to go live in March 2020, it has now been postponed to May 2022. Eudamed must include seven electronic systems including the UDI database 19. 1. Jan 23, 2024 · Posted on 23. To improve transparency and access to information, the new rules adopted in 2017 provided for the creation of a European database on medical devices (EUDAMED), which would eventually contain comprehensive data about all medical devices available on the European market. (European Database on Medical Devices) 유럽 의료기기 데이터베이스 EUDAMED는 유럽 의료기기 데이터베이스로 유럽 위원회가 Regulation(EU) 2017/745와 Regulation(EU) 2017/746을 구현하기 위해 개발한 IT 시스템 입니다. akahue ubjkkbnf ebup vqi pwvacaq wfbh izik ohosun cwad hptutpq