[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-243126-105":53,"doc-detail-243126-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","aim-business-process-business-process-overview","AIM-Business Process - Business Process Overview","","AIM-Business Process template provides a BPMN-based, high-level overview of the main processes within a module, designed to help stakeholders understand scope and system complexity. It outlines the purpose, scope by module and module codes, and a BPMN diagram legend covering process, swimlanes, start/end events, sequence and message flows, and task types. It also introduces the AIM process overview, including EUDAMED account management and account status handling workflows, plus authentication and access management 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EUDAMED handle account creation and activation in the AIM process overview?",{"text":118,"@type":110},"A registered Actor’s user requests account creation, an authorized local administrator assesses it, then EUDAMED creates the account and the requesting user activates it by accepting the User Rights and Obligations on first access.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},243126,1791732326,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":73},1374402524268,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","AIM-Business Process  \n1-Introduction  \nThis \"Business Process\" template shows the main processes contained in a module.  \nThe diagrams notation is based upon BPMN, only a handful of elements are presented to simplify the diagram.  \n2-Purpose  \nThis purpose of this document is to provide an overview of the main processes of a specific module.  \nThis high level representation is intended for stakeholders to be able to picture the scope and complexity of the system.  \n3-Scope  \nWe opted to provide business processes and their detailed descriptions by module.  \nMDR EUDAMED consists of several modules including:  \n\n| Module | Code |\n| --- | --- |\n| Actor Registration | ACT |\n| User Management | AIM |\n| Device | UDID |\n| Notified Bodies & Certificates | CRF |\n| Vigilance | VGL |\n| Clinical Investigation / Performance Study | CIPS |\n| Market Surveillance | MSU |\n\n4-Diagram legend  \n\n| Symbol | Name | Meaning |\n| --- | --- | --- |\n| | Process | Represents a collection of tasks performed by actors of EUDAMED |\n| | Swimlane / Actor type | This boundary box shows the tasks a specific actor can perform for a given process. |\n| | Start event | A black circle indicates a start event.\u003Cbr>A swimlane can contain multiple start event. |\n\n\n| | Sequence flow | The order of the process is indicated by these arrows. |\n| --- | --- | --- |\n| | Message flow |  |\n| | End event | A double filled circle indicated the end of a process. |\n| | Notification system task | An envelope icon indicates a system task who will create and send out notifications. |\n| | Task | A square box represents an interaction between an actor and the EUDAMED IT system. |\n\n5-Acronyms  \n\n| Term | Description |\n| --- | --- |\n| EC | European Commission |\n| MF | Manufacturer |\n| CA | Competent Authority |\n| EO | Economic Operator (AR, MF, IM, SPPP) |\n| AR | Authorised Representative |\n| IM | Importer |\n| Art | Article from the regulation |\n| NB | Notified Body |\n| SPPP | System or Procedure Pack Producer |\n| M2M | Machine to Machine (Web Services) |\n| LAA | Local Actor Administrator |\n| LUA | Local User Administrator |\n\n6-AIM Process overview  \n(First NB LAA shall not be included in release 0 . 1)  \n6.1-EUDAMED account management 6.1.1-Create a EUDAMED account  \nThis process consists of the following activities:  \n1. A user working for a registered Actor requests the creation of a EUDAMED account for this actor  \n2. A user of this actor with Local User Administrator rights (i.e. having the Local Actor Administrator or the Local User Administrator profile) assesses the request  \nIn the advent of a positive assessment:  \n1. EUDAMED creates the account, enabling the requesting user to perform activities on behalf of that actor  \n2. The user activates the EUDAMED account by accepting the User Rights and Obligations disclaimer on first access In the advent of a negative assessment:  \n6.1.2-Update a EUDAMED account  \nThis process consists of the following activities:  \n1. The user (Account owner) submits a Change Account request  \n2. A user of this Actor with Local User Administrator rights (i.e. having the Local Actor Administrator or the Local User Administrator profile) assesses the request  \nIn the advent of a positive assessment, EUDAMED updates the account.  \n6.1.3-Manage EUDAMED account status This process consists of the following activities:  \n LAA/LUA  \n Suspend an Account (this will not be included in Release 0 . 1)  \n Reactivate an Account (this will not be included in Release 0 . 1)  \n Terminate an Account  \n Resume an Account (this will not be included in Release 0 . 1)  \n Manage user access to a specific CI/PS (this will not be included in Release 0 . 1)  \n Authorised User  \n Suspend my Account (this will not be included in Release 0 . 1)  \n Suspend all my Accounts (this will not be included in Release 0 . 1)  \n Terminate my Account (this will not be included in Release 0 . 1)  \n Terminate all my Accounts (this will not be included in Release 0 . 1)  \n Resume my Account (th","cbCaimK4LoNEp6Ly","https://ap.wps.com/l/cbCaimK4LoNEp6Ly","pdf",159963,6,"English","# 1-Introduction\n# 2-Purpose\n# 3-Scope\n# 4-Diagram legend\n# 5-Acronyms\n# 6-AIM Process overview\n## 6.1-EUDAMED account management\n## 6.2-Authentication and access management","[{\"question\":\"What is the purpose of the AIM-Business Process template?\",\"answer\":\"It provides an overview of the main processes of a specific module so stakeholders can understand the scope and complexity of the system.\"},{\"question\":\"Which modules are included in MDR EUDAMED and what are their codes?\",\"answer\":\"The template lists Actor Registration (ACT), User Management (AIM), Device (UDID), Notified Bodies \\u0026 Certificates (CRF), Vigilance (VGL), Clinical Investigation / Performance Study (CIPS), and Market Surveillance (MSU).\"},{\"question\":\"How does EUDAMED handle account creation and activation in the AIM process overview?\",\"answer\":\"A registered Actor’s user requests account creation, an authorized local administrator assesses it, then EUDAMED creates the account and the requesting user activates it by accepting the User Rights and Obligations on first access.\"}]","AIM-Business Process - Business Process Overview | PDF",1789200410]