Eudamed user guide udi devices
Eudamed user guide udi devices. And once inside the EUDAMED device registration module, EUDAMED will recognise the SRN for linking devices to economic operators. Introduction 1. Bulk download of your devices via EUDAMED interface. The UDI is comprised of the UDI-DI and UDI-PI. EUDAMED is the database of Medical Devices available on the EU Market. However, to enter UDI/Device data Jul 17, 2024 · In your profile, scroll down to “Account data”; you will see that your UDI/Device access level is only set to “Viewer”. EUDAMED user guide. 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, 1 Introduction. In the future, when all modules will be released and EUDAMED has updated the user guide UDI Devices - Production v 2. Modules. The purpose of this user guide is to help you navigate through the Notified Bodies and Certificates process of registering certificates module into EUDAMED. The pages collate information about the modules, including the user guide, technical documentation and guidance. Notified Bodies Access. EUDAMED is the IT system implementing Regulation 2017/745 on medical devices, and Regulation 2017/746 on in vitro diagnosis devices. , as shown below: EUDAMED user guide. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. 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, EUDAMED has updated the user guide UDI Devices - Production v 2. 2 Changed. 1. However, to enter UDI/Device data in EUDAMED, you must request access for the UDI/Device module with a higher profile. The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world. 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. 1 Overview. The following document describes in more detail how it works. EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors registration. Jan 18, 2021 · EUDAMED provides three options for you to enter your device data into the system, manual data entry and two options using XML files containing your Basic UDI’s and UDI DI’s. 14. as either: Nov 30, 2023 · The Unique Device Identification (UDI) and Device Registration module enables manufacturers to register their devices before placing them on the market. as either: Aug 2, 2022 · Version 2. EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device Apr 18, 2022 · A step-by-step guide will guide you through the respective registration processes. Operators user guide. 2. RESOLVED When registering a new Basic UDI DI(/EUDAMED DI), if the Manufacturer is NonEU, must specify the Authorised Representative for the Basic UDI-DI/ EUDAMED DI. Management of Regulation Devices and Legacy Devices 15. Certificate information and related SS(C)Ps information (if applicable) are being displayed within the Basic UDI-DI/EUDAMED DI section. Sep 25, 2020 · What is UDI? Unique Device Identification (UDI) intended to assign a unique identifier to medical devices within the United States, it marks and identifies individual medical devices throughout their distribution and product life-cycle. Its purpose is to strengthen market surveillance and transparency in medical device field providing to competent national authorities with quick access to information. Legacy Devices. Documentation. 2. ec. If you answered No to the above question, fill in the information in the appearing fields including Applicable legislation, Risk Class etc. g. However, to enter UDI/Device data in EUDAMED, you must request access for the UDI/Device module with a higher profile [5] as either: Guidance on basic UDI-DI and changes to UDI-DI: April 2021: MDCG 2020-18: MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers: December 2020: MDCG 2019-2: Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017: February 2019: MDCG 2019-1 A. 12 September EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations Once Eudamed is fully functional, this will become the mandatory registration system. Initially, the UDI system was created, developed, and maintained by the device manufacturer based on global device… Oct 8, 2021 · Strategy definition for Eudamed registration; UDI request (Basic UDI-DI, UDI-DI, EUDAMED DI, EUDAMED ID) Data mapping; Data upload; QMS support for Eudamed maintenance; If you are interested in receiving further details, do not hesitate to book a free meeting with us here: Asphalion Meeting Point SAVE THE DATE!. 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, Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. for bulk upload functionality and machine to machine communication). Here are some link to better understand UDI and EUDAMED Document Short summary Author […] Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. 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. For the Vigilance module, NRDs are Old Devices or Custom-made Devices. EUDAMED user guide UDI Devices – Production Link to document 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. Unique Device Identifier (UDI) Questions related directly or indirectly to the UDI (e. 3. Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. 8 of Technical documentation - UDI/Devices registration News announcement 2 August 2022 Directorate-General for Health and Food Safety 1 min read More information This site uses cookies. Therefore, click “Request for Change”. The new MDR 2017/745 and IVDR 2017/746 EU regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI) and require that manufacturers of medical devices submit the UDI/Device information of all devices/products that they place on the market. NOTE. DDG1. UDI Devices – User guide EUDAMED v2. How can a user request access to EUDAMED? The process to request access is described in the Infographic user access requests. This includes details about the device and its classification. UDI Devices Module (https://lnkd The UDI-DI/Device module of EUDAMED is used for this purpose. Apply the correct filters from the list presented in order to identify your devices that you want to 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. e. 6 Let us know your thoughts about it! #EUDAMED #UDI #guidancedocument #Playground #ECREP #MDSS. Regulation \(EU\) 2017/745 Aug 2, 2022 · Version 2. Notified Bodies and May 29, 2019 · For 50 to roughly 500 devices, manual XML bulk uploads can be competed using an upload form within the Eudamed application; however, you will still need to prepare validated XML data. 5 Training and training material and online training facilities (e-Learning) The 2024 'EUDAMED user guide - Legacy Devices' note is a document that contains details on how… The European Commission has released a new note on EUDAMED. 3 UDI/Devices module. Before you start entering details of a UDI/device in EUDAMED, please ensure you have all the required information at hand, including the Basic UDI-DI and UDI-DI codes. Please guide us how we register our Class I device to EUDAMED without an NB certificate. 3 Fixed. It improves transparency and coordination of information about those Aug 10, 2019 · User guide for UDI module of EUDAMED published. as either: Mar 30, 2022 · 1) EUDAMED (European Database on Medical Devices) 유럽 의료기기 데이터베이스로서 의료기기, 관련된 Economic operator(경제적 운영자), 적합성 평가의 특정 측면, 인증기관, 인증서, 임상시험, 감시 및 시장 조사 등에 대한 정보를 수집하여 처리하는 의료기기와 관련된 유럽 EUDAMED is the European Database on medical devices. 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, Jun 21, 2023 · The European Commission published a new EUDAMED user guide about the registration of certificates. Are you sure you can share it? I did not find it either (although I'm not sure, because the EC website has been revamped and my links to docs are not working anymore), but Eudamed is being tested at the moment by the people involved (and this is the type of document that would be part of that, although not for public yet). Purpose 1 Apr 11, 2022 · The EUDAMED UDI/Devices module updated technical documentation is available News announcement 11 April 2022 Directorate-General for Health and Food Safety 1 min read More information The UDI-DI/Device module of EUDAMED is used for this purpose. Overview. After you log in as a user for an economic operator, you will be able to access the list of your Devices registered in EUDAMED by using the Search & View functionalities for Devices: 1. Here are some of the main topics: Basic UDI-DI Identification Details: The guide provides instructions on how to fill in the medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies EUDAMED is integral part of the implementation of the two Medical Devices Regulations. EUDAMED has updated the user guide UDI Devices - Production v 2. Technical documentation shall be provided where needed (e. Nov 5, 2021 · We would like to show you a description here but the site won’t allow us. Master UDI-DI is an identifier of a group of highly individualised products/devices presenting specific similarities with respect to defined clinically relevant parameters. medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies specific medical device on the market. See full list on health. EUDAMED restricted; EUDAMED public; Video for the public; Video for the restricted; Disclaimer: Currently only the Actor, the UDI/Device and the Notified Bodies and Certificates modules are available. If the device is not yet assigned a UDI-DI by the manufacturer on registration, the system provides a EUDAMED-DI and auto-generates the appropriate EUDAMED-ID. 4 - Publication date: n/a - Last update: Wed Dec 04 09:46:30 CET 2019 Download links: Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. 11. For further information on EUDAMED, please visit the medical devices section of the European Commission website. 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, The UDI-DI/Device module of EUDAMED is used for this purpose. The UDI (Unique Device Identification) system is one of the main novelties brought by the MDR 2017/745 and IVDR 2017/746 EU regulations. SRN이란, EUDAMED 및 관련 공식 문서 및 관련 보고서에서 모든 경제 운영자(Economic Operator)를 고유하게 식별하는 단일 등록 번호(Single Registration Number) 입니다. UDI/Devices registration. Please make sure that you understand all concepts and have all information at hand before starting to register a new UDI/device or a system or procedure pack (SPP). 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, If you answer Yes, provide the UDI-DI of the device. It is applicable with REGULATION (EU) 2017/745 on medical devices only. SRN은 EUDAMED에 의해 생성되고 EUDAMED에서 Actor 등록 요청을 검증한 관계 당국에 의해 EUDAMED를 통해 발행됩니다. as either: NEW EUDAMED user guide Economic Operators – Actor module Production v 2. , registration is immediate for most devices. European Medical Devices Nomenclature 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 database should also be (partially) accessible to the public. When an actor is registered in EUDAMED, everyone who intends to act on behalf of this actor needs to submit an access request. During the device registration, you also have to specify what Basic UDI-DI the device (UDI-DI) you are registering belongs to. The production of a UDI comprises the following: • A UDI device identifier (‘UDI-DI’) specific to a device, providing This document covers only the assessment of data related to the EUDAMED modules that are available and can be used on voluntary basis: Actors registrations, UDI/Devices, and NBs & Certificates modules. 4 - Publication date: Fri May 03 12:28:38 CEST 2019 - Last update: Fri May 03 12:29:14 CEST 2019 Feb 15, 2021 · Legacy devices are exempt from the requirement to get a Basic UDI-DI and UDI-DI, or unique device identifier. These XML files can be uploaded manually to EUDAMED or using a far more expensive and complex automated solution using an automated Machine to Machine option, which on 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. Here are some of the main topics: Basic UDI-DI Identification Details: The guide provides instructions on how to fill in the medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies Aug 9, 2024 · We already have SRN for our organization but EUDAMED “Register a legacy device module” under the UDI-DI/ Device section does not allow us to register our device without certification information from NB. Legacy Devices Legacy devices are defined as medical devices, active implantable medical devices and in vitro Sep 15, 2021 · EUDAMED functionality is intended to provide for the exchange of information regarding vigilance reporting, clinical investigations, certificate notifications and registration of devices and economic operators, as well as exchange of information between competent authorities. Commonly referred to by its shorthand BUDI-DI, this product group identifier includes one or more related “child” medical devices, i. 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, Jan 9, 2020 · EUDAMED Actor module User Guide – for Economic Operators Introduction 4 4. Dec 16, 2022 · Medical Devices - EUDAMED. Old Device: Devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of However, with Notified Bodies and Certificates, Legacy Devices, and UDI Devices, only three different files are available so far. 1. MDR 서문 (44) 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, certificates, clinical To register in EUDAMED, non-EU manufacturers must have an active authorised representative and submit a mandate summary document with their registration request. Apr 17, 2022 · One primary difference between the UDI GUDID and the UDI EUDAMED requirements is family product grouping called Basic UDI-DI. How do I register my devices on Eudamed? Economic operators must register the following devices using the Eudamed device registration module; MDR compliant class I, IIa, IIb, III and class III implantable custom-made devices, system and procedure packs and, 4 User guide and technical documentation A user guide in all official languages shall be provided for the information system. It is intended to improve the traceability of medical devices throughout the supply chain by connecting all the information about every single medical device. EUDAMED UDI-DI/Devices User guide DG SANTE A Basic UDI-DI always references at least one UDI-DI, while multiple UDI-DIs can be referencing the same Basic UDI-DI. as either: The UDI-DI/Device module of EUDAMED is used for this purpose. Guidance documents and manuals. 7 . Jan 9, 2021 · There are no limitations in EUDAMED on who can be the LAA, except that the LAA will need an EU Login account as any other type of users, it is the Actor’s decision to choose the person who will be LAA. eu medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies Basic Concepts. The UDI-DI/Device module of EUDAMED is used for this purpose. For notified bodies: Notified Bodies User Guide; For economic operators: Guide to using EUDAMED; UDI/Devices User Guide The Unique Device Identification (UDI) and Device Registration module enables manufacturers to register their devices before placing them on the market. Here are some of the main topics: Basic UDI-DI Identification Details: The guide provides instructions on how to fill in the EUDAMED UDI Device Data Dictionary Document date: Thu May 02 00:00:00 CEST 2019 - Created by GROW. europa. However, to enter UDI/Device data in EUDAMED, you must request access for the UDI/Device module with a higher profile . UDI Devices user guide Jun 24, 2021 · In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU. Infographic: Users access requests 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. Enter your EU Login password and click Sign in. EUDAMED user guide UDI Devices – Production v 2. The new chapter provides detailed instructio The UDI-DI/Device module of EUDAMED is used for this purpose. Clinical Trials Information System (CTIS) – Sponsor Handbook; Version 3. Overview of the MDR UDI and device data sets and IVDR UDI and device data sets to provide for their registration in EUDAMED. 11 More general information about EUDAMED: Medical Devices - EUDAMED. It introduces key concepts like the Basic UDI-DI, which is the main access key for device information in the EUDAMED database. The EUDAMED Information Centre contains the relevant updated documentation including User Guides, technical documentation and Q&A sections. The last two also deal with the UDI registration module. Register a new NCAR 13 MDR - UDI and device data sets to provide in EUDAMED Document date: Thu May 02 00:00:00 CEST 2019 - Created by GROW. After completing the registration, the Authorised Representative must verify the UDI and Device information registration in EUDAMED performed by the non-EU manufacturer. However, legacy devices do need a EUDAMED DI, the equivalent of the Basic UDI-DI, to ensure all devices in the database have the same standard structure and identification elements. EUDAMED Users. The new chapter provides detailed instruc This document provides a user guide for registering medical devices and system/procedure packs in the EUDAMED UDI-DI/Devices module. Fields marked with a red asterisk are mandatory. EU Commission’s EUDAMED UDI/Devices User Guide states: “After Submitting the Device, the state of the Device (Basic UDI-DI and UDI-DI) will be: Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. EUDAMED also contribute to the uniform application of the Directives. D. 👇 Check out this EUDAMED user guide - UDI Devices - Playground v 3. No new development. In the next screen, add your name and title, and then click next. 1 1, February 202 4)) was published by the European Commission providing guidance on the management of certificates and Summaries of Safety and Clinical Performance (SSCPs) for implantable and Class III non-IVD medical devices and Summaries of Safety and Performance (SSPs) for Jun 23, 2022 · Only the UDI-DI part of the UDI is to form input into EUDAMED. medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. as either: 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. 8 of Technical documentation - UDI/Devices registration News announcement 2 August 2022 Directorate-General for Health and Food Safety 1 min read More information Jul 28, 2023 · The June 2023 release of the EUDAMED User Guide UDI Devices included a new chapter on the registration of UDIs, updated information on the requirements for UDIs, improved clarity and readability, and a new section on the use of the UDI helpdesk. 1 2. EUDAMED registered users. In the final screen, click the checkbox “Confirmer” for UDI/Device and then submit. The Actor registration is the first of the six EUDAMED modules. For those with over 500 devices and/or those who want to automate the process with far fewer than 500 devices then you can use the machine-to-machine interface. UDI/Devices Data sets. Revision Date: 2024-08-06. The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their UDIs/Devices information and to make it available to everyone The UDI-DI/Device module of EUDAMED is used for this purpose. 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, May 16, 2024 · EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module; MDSAP AUDIT APPROACH UPDATED. Mar 24, 2017 · The solution: The Unique Device Identification (UDI) system What is the UDI system? The UDI system is defined, by the International Medical Device Regulators Forum (IMDRF) in the UDI Guidance, as “the framework for: 1) UDI production, 2) UDI application on the label or on the device, and 3) UDI Database (UDID) fundamental contents” medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices • Certificates and Notified Bodies Jul 27, 2023 · The June 2023 release of the EUDAMED User Guide Notified Bodies & Certificates included a new chapter on the registration of certificates, updated information on the requirements for certificates, and improved clarity and readability. 9 brings significant changes to the implementation of the Master UDI Sep 21, 2021 · If a UDI-DI is already assigned, the manufacturer can use the UDI-DI for the EUDAMED-ID/UDI-DI. UDI Helpdesk. The guide for legacy devices contains detailed instructions on how these devices can be identified, registered, and managed in EUDAMED. Link to document Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. Before the change, the information was presented within the UDI-DI/EUDAMED ID section of a device details page. Regulation \(EU\) 2017/745 the following chapters of the dedicated UDI Devices user guide: • Manage your device Basic UDI-DI/EUDAMED DI details • Manage your device UDI-DI/EUDAMED ID details • Search & View Devices, Systems and/or Procedure Packs EUDAMED user guide. The two are differentiated by a B prefix (for the EUDAMED-DI) and a D prefix (for the UDI-DI). Jun 18, 2024 · The EUDAMED user guide was updated in February 2024 (EUDAMED user guide – Notified Bodies & Certificates (v 2. UDI assignment, labelling and registration of devices, use of the European Medical Device Nomenclature) are answered by the UDI Helpdesk: UDI Helpdesk. April 2022 Jul 17, 2024 · EUDAMED device applications are automatically registered, unless the Basic UDI-DI information needs to be verified by the Notified Body, i. 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, Aug 30, 2023 · Article 32 requires adding a summary of safety and performance to EUDAMED for class III devices and implants. EUDAMED is the IT system implementing Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. What’s the process to register a Regulation device in EUDAMED? DEVICE IS REGISTERED SUBMIT START REGISTRATION PROCESS DEVICE IS REGISTERED DEVICE IS SUBMITTED CONFIRM DEVICE DATA ˜˚˛˝˙˚ˆˇ˝˘ ˘ ˛ ˇ ˙ REGISTRATION PROCESS FOR REGULATION DEVICES A Regulation Device has to have an assigned Basic UDI-DI and UDI-DI and has to be Oct 10, 2021 · What exactly is EUDAMED? EUDAMED is the European Database on Medical Devices. EUDAMED Information Centre; Documentation; User guides and templates Economic Operators. Dec 2, 2021 · Earlier in November, the Commission published documents and information about UDI/device registration and Notified Bodies and Certificates, the two latest Eudamed modules to go live. 1 New. The guide outlines the step-by-step registration process for new devices/UDI-DIs and system/procedure packs, as well as how to manage Jun 13, 2023 · 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). Result: If you do not have any pending/registered account(s), EUDAMED opens the User and Actor Registration page: Figure 4 – EUDAMED User and Actor Registration page To quit EUDAMED 1. For a wider understanding on how to use the platform, visit the EUDAMED Information Centre. , the UDI-DI which applies to specific devices. The following special device types require the registration of Master UDI-DI: UDI/Devices module but are to be referenced in a Vigilance report can be registered in EUDAMED as NRDs. Aug 6, 2024 · BR-UDID-731: Master UDI-DI. €The Authorised Representative provided for the Basic UDI-DI/ EUDAMED DI has to be registered in EUDAMED and to have an active Mandate registered in EUDAMED with the Manufacturer Enter the device information in the Device Module, following the user guide provided by the EU Commission. dfjfroos omlsar otlr lbpfn eei gfzjxh icff glkuxv yssl saauljvp