Eudamed registration procedure

Eudamed registration procedure. MVP overview. • Infographic: Actor registration request process • Video: Demo actor registration module 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 Actors registration, Vigilance and post-market surveillance, market surveillance, UDI/Device registration and NB and Certificates. User profile registration in EUDAMED For information on how to gain access to EUDAMED, please consult the Economic Operators user guide. As of January 2026 (expected date), economic operators will be required to register in the European database EUDAMED for this purpose (MDR, Article 31; IVDR, Article 28). info@mdrc-consulting. EUDAMED는 유럽 의료기기 데이터베이스로 유럽 위원회가 Regulation(EU) 2017/745와 Regulation(EU) 2017/746을 구현하기 위해 개발한 IT 시스템 입니다. Registration of Legacy Devices Oct 8, 2021 · After a long wait, October 4th, 2021, marks de date the European Commission made the UDI/Device Registration module 2 of Eudamed available. The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number (Actor ID/SRN). 2020. Will actor information registered in EUDAMED be publicly available already from 1st December 2020? 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). Registration of Basic UDI-DI together with the first UDI-DI for a System or Procedure Packs EUDAMED allows system Jul 25, 2024 · The new legislation includes the creation of a centralised European database called Eudamed. Next, Manufacturers and System/Procedure Pack Producers must register their devices in EUDAMED’s UDI/Device Registration Module. EUDAMED is structured around 6 interconnected modules and a public website: Actor registration; UDI/Device registration; Notified Bodies and Certificates I have submitted an actor registration request, where can I find its application ID? A: You can find your application ID on My pending requests page. Please make sure that you understand all concepts and have all information at hand before starting to register a new UDI/device. NOTE When completing your registration on Eudamed, please follow the instructions provided in the Eudamed user guide. Jan 9, 2021 · Posted: January 9, 2021 / Under: Actor Registration, EUDAMED Actor Registration EUDAMED Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information. Aug 13, 2024 · Requests for an SRN are submitted via EUDAMED and then reviewed by a national Competent Authority (Ministry of Health) who then issues the number. As such, the actor registration module forms a pre-requisite for the use of the other EUDAMED modules and facilitates a secure way of EUDAMED is the IT system that will be made of 6 modules, among which the first one is the Actor registration module, 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 . Mar 14, 2022 · The SRN is a key component of EUDAMED’s traceability functionality. Registration of legacy devices. One of the key aspects of the new regulations is the implementation of a European Database on Medical Devices (EUDAMED) to assure the data and information needed on economic operators, product registration, quality certificates, declaration of conformity, clinical investigations, and post-market surveillance by all stakeholders (competent Oct 10, 2021 · For example, the Irish Competent Authority asks manufacturers to register in EUDAMED to fulfil the MDR/IVDR registration requirement, even though use is voluntary. Jul 22, 2021 · General guidelines on the EUDAMED registration procedure currently under preparation With the guideline MDCG informs that an Implementing Regulation by the European Commission is being prepared , a Regulation on the procedures according to which all actors , including those not subject to Art. Non-EU Manufacturers will have to select the authorised representative for the Basic UDI-DI amongst those with which they have an active mandate registered in EUDAMED. 11 June 2023) Aug 25, 2023 · The EUDAMED database is set by the European Commission at EU level and is one of the new requirements under the MD and IVD Regulations. Once the device registration has been completed, Importers will link themselves to the devices that they import into Europe. Aug 9, 2024 · Until all the six planned EUDAMED modules are finalised, you should check with your Authorised Representative whether their Competent Authority requires Manufacturers to use the already available EUDAMED modules or an alternative (national) registration procedure. With this registration, manufacturers will receive the SRN number, required by notified bodies for the conformity assessment procedure. EUDAMED is the IT system that will be made of 6 modules, among which the first one is the Actor registration module, 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 . Jun 3, 2021 · For more information on timing, and the process to voluntarily register early, please read: EUDAMED Basics. EUDAMED Registration Procedure. importers) established in Turkey can submit actor registration requests in EUDAMED. The market authorisation of medical devices (MDR, EU/745) and medical devices for in vitro diagnostics (IVDR, EU/746) requires registration. Switzerland. Sep 15, 2021 · The revised EUDAMED launch date coincides with the implementation date of the IVDR, and in October 2020 the EC confirmed that a ‘Minimum Viable Product (MVP)’ approach to EUDAMED is to be implemented and that EUDAMED is to be declared fully functional when the MVP is reached. • The person who performs the registration automatically becomes Local Actor The UDI data will be registered on the EUDAMED database. Actor registration request Correct Actor registration request Assess Actor registration request VALIDATION PROCESS AND NOTIFICATIONS What’s the validation process for an economic operator to obtain an Actor ID/SRN REQUEST REFUSED ˝ ˚˜˚ˇ ˆ ˚ ˝ ˚ EU manufacturer, authorised representative, importer and system/procedure pack producer Jun 29, 2021 · The #MDCG has just released a Q&A on the rules and obligations for registration in #EUDAMED for actors other than manufacturers, authorized representatives, and importers. A manufacturer or their authorized representative must first apply for a Single Registration Number (SRN). 5. 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 Oct 14, 2021 · Yes, Turkish economic operators (including manufacturers, SPPP, AR and importers) established in Turkey can submit actor registration requests in EUDAMED. 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 registered in the ‘UDI/Device module’ of EUDAMED. Specifically, they state that: “The HPRA recognises the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. Regulation (EU) 2024/1860 establishes the rules for the registration of legacy devices in Actor registration request Assess Actor registration request VALIDATION PROCESS AND NOTIFICATIONS What’s the validation process for an Economic operator that is not a non-EU manufacturer to obtain an Actor ID/SRN REQUEST REFUSED ˝ ˚˜˚ˇ ˛ ˚ ˝ ˚ EU manufacturer, authorised representative, importer and system/procedure pack producer Need EC REP or PRRC for the EU? Contact us right now: +49 176 67510274. Registration of economic operators in EUDAMED The new rules governing market authorisation for medical devices (Regulation (EU) 2017/745, MDR) and in vitro diagnostic medical devices (Article 30 of Regulation (EU) 2017/746, IVDR) introduce changes. 31 of the MDR or Art. Nov 5, 2020 · Posted on 05. The actor registration is not yet mandatory but necessary when applying to a notified body for a conformity assessment procedure. EU Importers. As a side note, as you might have noticed, EUDAMED is called MDR EUDAMED on the Actor Registration module landing page. Manage your SPP UDI-DI details If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you from saving, as a Basic UDI-DI must be unique. This portion of the EUDAMED database is called the “Actor Registration Module. A key change for both economic operators and EU Member States is the obligation to record information centrally in the European EUDAMED database Actor registration request process • Economic operators (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) have to register as an actor in EUDAMED and provide the required information. If you meet the definition of more than one type of economic operator, you must complete multiple Eudamed registrations. Dec 7, 2020 · The long-awaited EUDAMED database is finally beginning to become reality with the first module on Actor registration released on December 1st. On 1 st of December 2020, the European Commission made available the Actor Registration module; the first EUDAMED module to be operational. Jul 17, 2024 · The Irish competent authority for example, requires registration of Class I, IIa, IIb and III (non-implantable) custom-made devices via their online form. Dec 16, 2022 · The Actor registration is the first of the six EUDAMED modules. How is the Actor Registration in EUDAMED performed? Economic operators (including manufacturers, system/procedure pack producers, AR and importers) established within the EU 27, Iceland, Liechtenstein and Norway will be able to submit actor registration requests in EUDAMED from December 2020. Therefore, additional national requirements on registrations cannot be excluded. . 28 of IVDR, will register Nov 2, 2020 · The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from 1st December 2020. EUDAMED is the database of Medical Devices available on the EU Market. 32. Actor Registration Process. System/Procedure Pack Producers. The EUDAMED registration process involves several steps. EUDAMED is a portal that consists of 6 modules and the Actors module serves as the establishment registration portal in the EU. The SRN guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED). Overview of the various roles for market participants. To use EUDAMED, you must have an EU Login account associated with your professional email address and the manufacturer for which you want to act on behalf must be registered as an actor in EUDAMED. UDI/Devices registration Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification… The Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed arrangements necessary for the setting up and maintenance of EUDAMED. However, they accept the EUDAMED registration of Class III implantable devices as sufficient, and do not require an additional direct registration through their system. 1 Any organization who performs the following roles must register in the actors […] This site uses cookies. You will land on the User and A Select the Actor Registration widget on the User and Actor Registration page. 2. SRNs are for manufacturing, authorized representatives, and importers of MDs and IVDs. The System/Procedure pack producer (PR) is responsible for the registration of System/Procedure packs in EUDAMED. 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. You can look up which authority is responsible for you via a table in EUDAMED. 27, 29, 31 (UDI / Eudamed) All MPDG §8, §96, §97 All ISO 13485:2015, Sections 4. The EMDN is the nomenclature to be used by manufacturers when registering their medical devices in EUDAMED. Will actor information registered in EUDAMED be publicly available already from 1st December 2020? Yes, the EUDAMED public website will be made available on 1st December 2020 together with the restricted EUDAMED site. A step-by-step wizard will guide you through the device registration process. I've searched, but must be overlooking. The first 5 EUDAMED modules are released. INFOGRAPHIC: Actor registration request process. Jun 24, 2024 · With the registration, economic operator receives the Single Registration Number (SRN). The purpose of SRNs is to establish a unique identity for every economic operator in the EUDAMED. Manufacturers in these countries can of course register in Eudamed as non-EU manufacturers, including their Person Responsible for Regulatory Compliance. In accordance with Article 30(1) MDR, the actor registration module shall allow for the creation of a unique single registration number (‘SRN’) referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer (including producers of system/procedure packs) and, where applicable, the authorised representative and the importer. To complete a registration on Eudamed: EUDAMED is the IT system that will be made of 6 modules, among which the first one is the Actor registration module, 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 . This SRN is unique identifier used across the EU to identify the manufacturer in the EUDAMED system. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. Mar 8, 2022 · Actor Registration Module. Actor registration request Assess Actor registration request VALIDATION PROCESS AND NOTIFICATIONS What’s the validation process for an Economic operator that is not a non-EU manufacturer to obtain an SRN REQUEST REFUSED ˝ ˚˜˚ˇ ˛ ˚ ˝ ˚ EU manufacturer, authorised representative, importer and system/procedure pack producer ACTOR 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 registered in the ‘UDI/Device module’ of EUDAMED. ˜˚˛˝˙ ˆˇ ˘ ˘ ˆ˝ ˝ ˙ ˚ ˝ Jan 9, 2021 · Actor Registration Process. The table in EUDAMED is decisive for the registration in EUDAMED! DMIDS: Product Notifications, Clinical Investigations and Performance Studies collate and process information that is necessary and proportionate to identify the manufacturer (including producers of system/procedure packs) and, where applicable, the authorised representative and the importer. For simplicity, the following abbreviations will be used in the remainder of this document : MD : Medical Device Eudamed : European database on medical devices Jun 30, 2021 · General Eudamed registration procedure guidelines still to come First, MDCG notes that a forthcoming Commission Implementing Regulation still being prepared by European Commissioners will cover procedures whereby all actors including those not subject to MDR Article 31 MDR or Article 28 IVDR will register under Eudamed. The European Commission has launched a new dedicated webpage for collecting all necessary information on actor registration in EUDAMED. 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 further information on EUDAMED, please visit the medical devices section of the European Commission website. These are for actors subject to the obligations of Article 28 (IVDR) and Article 31 (MDR), and clarifies the cases where, instead of a SRN, and Actor ID is issued. 2. This can be an individual or an organisation – both can be considered an ‘actor’ in EUDAMED. Referring to articles 29, 30, and 31, before the devices are subjected to the CA procedure, the manufacturer should assign a basic UDI-DI and provide it to the UDI database. There are two ways to gain access to EUDAMED: Request registration for an economic operator Register your Actor in EUDAMED with the appropriate actor role. Conformity Assessment Procedures: The specific conformity assessment procedure applicable to your device hinges on its risk class. The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. solution that just meets the bare-minimum Who is the authority responsible for the approval of actor registration requests of SPPP location in non-EU countries? A: The authority responsible for the approval of non-EU SPPP's actor registration requests should be the authority of the area where the first system or procedure pack of that producer is to be placed on the market. ” If a manufacturer is located outside of the European Union, their Authorized Representative will verify the To access the clarifications and instructions for the registration and verification of other EUDAMED users connected with individual economic operators – EUDAMED user guide – Economic Operators – Actor module (Production v 2. Nov 30, 2023 · The EUDAMED registration process involves several steps. Please note: The German competent federal state authority listed in EUDAMED differ slightly from the authorities in DMIDS. We recognise the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. EUDAMED는 총 6개의 구조로 이루어져 있으며, 2020년 12월 1일 Actor registration (행위자 등록) 에 대한 모듈이 가동되었습니다. The validation for actor registration is done in steps which are listed as; The economic operator sends an application in EUDAMED for an actor registration request and shares required documents by uploading it on EUDAMED. What is the process of notification or registration of the product? Before placing a medical device or in vitro diagnostic medical device on the market, the marketing entity is obliged to make a notification to the relevant Competent Authority or to the EUDAMED database. Jan 9, 2020 · EUDAMED Actor module User Guide – for Economic Operators Introduction 4 4. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). There are two ways to gain access to EUDAMED: Request registration for an economic operator Register your actor in EUDAMED with the appropriate actor role. 1 Will actor information registered in EUDAMED be publicly available already from 1st December 2020? Yes, the EUDAMED public website will be made available on 1st December 2020 Dec 7, 2020 · Actors’ Registration Validation. • UDIs, assigned by the manufacturer to their device 1. EUDAMED uses a number of identification systems to categorize certain datasets, including: • SRNs, which will be automatically assigned to manufacturers, ARs, importers and system/procedure pack producers, referred to as actors, by EUDAMED upon registration. 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. Registration of a UDI-DI for an existing Basic UDI-DI of a System or Procedure Pack. Registration of Legacy Devices Apr 26, 2024 · Regulatory Requirement Document Section MDR Annex I (General Safety and Performance Requirements), Annex IV (EU Declaration of Conformity), Art. For information on the current registration requirements until EUDAMED is mandatory, please read: EU Registration Requirements. 3 Publication of a Commission notice in the Official Journal of the European Union (OJEU). Registering System or Procedure Packs. It is the responsibility of the actors to ensure that the information in Eudamed is always kept up to date. To stay up-to-date with EUDAMED development and Nov 8, 2021 · EUDAMED UDI/Devices registration module - Relevant documents and information News announcement 8 November 2021 Directorate-General for Health and Food Safety 1 min read Related Documents will not be able to submit actor registration requests in EUDAMED in the absence of an updated Customs Union Agreement. From that moment, manufacturers will have to respect the following timeline to register: Within 6 months for actor registration. The EMDN is fully available in the EUDAMED public site. Aug 23, 2022 · General Validation Process to Get an SRN. You can find more information about Eudamed on the EUDAMED information center. Manage your SPP Basic UDI-DI details. In short, the Eudamed registration process starts with the economic operator. A manufacturer—or their authorised representative—must first apply for Single Registration Number (SRN). The Actor registration module enables economic Jan 9, 2021 · Posted: January 9, 2021 / Under: Actor Registration, EUDAMED Actor Registration EUDAMED Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information. The Device module of EUDAMED is used for this purpose. The Actor registration module enables economic There are two ways to gain access to EUDAMED: Request registration for an economic operator Register your actor in EUDAMED with the appropriate actor role. Below, you will find "questions and answers " regarding the registration of actors on Eudamed. 1. For more information on the EMDN, see also the EMDN Q&A. Log into EUDAMED with your EU Login account (See Section Starting and ending a EUDAMED session). Q: Clarifications and instructions for entering an economic operator into the Actor registration module are available here or at the JAZMP link – Registration procedure for EUDAMED. No, you cannot delegate your user profiles, but other users can request LAA and LUA profiles. Jun 9, 2023 · All Economic Operators (manufacturers, system/procedure pack producers, authorized representatives, importers, and distributors) are subject to MDR Articles 94, 95, and 97, on investigating and dealing with devices presenting an unacceptable risk to health and safety, and ‘other non-compliance’. Actor registration request Assess Actor registration request VALIDATION PROCESS AND NOTIFICATIONS What’s the validation process for an Economic operator that is not a non-EU manufacturer to obtain an Actor ID/SRN REQUEST REFUSED ˝ ˚˜˚ˇ ˛ ˚ ˝ ˚ EU manufacturer, authorised representative, importer and system/procedure pack producer May 26, 2021 · Information for EUDAMED ACTOR registration: According to 4/2009 EüM Decree from 17. 1 Will actor information registered in EUDAMED be publicly available already from 1st December 2020? Yes, the EUDAMED public website is available since 1st December 2020 together with the restricted EUDAMED site. • The person who performs the registration automatically becomes Local Actor To use EUDAMED, you must have an EU Login account associated with your professional email address and the manufacturer for which you want to act on behalf must be registered as an actor in EUDAMED. These organizations are ‘Economic Operators’ and will register themselves in the EUDAMED ‘Actor’ registration module. Registration in the national Register of economic operators established in the Republic of Slovenia that carry out activities in the field of medical devices is . Once Eudamed is fully functional Actor registration request Assess Actor registration request VALIDATION PROCESS AND NOTIFICATIONS What’s the validation process for an Economic operator that is not a non-EU manufacturer to obtain an Actor ID/SRN REQUEST REFUSED ˝ ˚˜˚ˇ ˛ ˚ ˝ ˚ EU manufacturer, authorised representative, importer and system/procedure pack producer Jan 9, 2021 · The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). Registering as an Economic Operator. Jan 9, 2021 · The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). com 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 registration of Medical devices in EUDAMED. Lower-risk devices (Class I and IIa) generally involve fewer complex procedures, while higher-risk devices (Class IIb and III) necessitate the involvement of a Notified Body. Feb 27, 2024 · Hi All, Where in MDR 2017/745 does it state that a documented procedure for Eudamed Registration is required in your QMS. August 2021 it is obligatory for Manufacturers, Importers, Authorised representatives, System & Procedure Pack Producer register using the registration module of Eudamed. Registration of a Basic UDI-DI together with a UDI-DI for a System or Procedure Pack. Alternatively, Obelis can assist the manufacturer in the EUDAMED registration process, leading to fast validation and SRN number issuance. There is no limitation on the number of users with the same profile for an actor. Enter your EU Login password and click Sign in. EU Authorized Representatives. If you have no actor registered yet, this page is your homepage when accessing EUDAMED. They need to mandate an Authorized Representative based in the EU. Here are the steps in the validation process to get an SRN: The economic operator requests an actor registration from Apr 8, 2024 · Fig 2: EUDAMED Registration. This process must be initiated by the user who is requesting access, and access is approved or rejected by an active LUA or LAA. The European Commission’s EUDAMED module for SRN registrations went live on December 1st 2020. 3 All Summary This SOP describes how a medical device is brought to the market while observing applicable regulatory requirements, including […] Oct 20, 2023 · For more information about the registration process in Eudamed. Jul 17, 2024 · The following company types must register in EUDAMED: Manufacturers. Jan 25, 2022 · The EUDAMED Actor Registration Module was the first module to become available in December 2020 to the following actors: regulatory bodies (such as EC, competent/designating authorities, notified bodies), economic operators (such as manufacturers, procedure kit/system manufacturers, importers, and authorized representatives) EUDAMED is the IT system that will be made of 6 modules, among which the first one is the Actor registration module, 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 . Registration in EUDAMED is mandatory after the European Commission announces that the database is fully functional. Actor registration process 2. • The person who performs the registration automatically becomes Local Actor Jan 9, 2020 · EUDAMED Actor module User Guide – for Economic Operators Introduction 4 4. What is the procedure to register as actor in EUDAMED? The procedure to register as actors in EUDAMED3 will be laid down in a Commission Implementing Regulation on EUDAMED (in preparation), which will be applicable to all natural or legal persons registering to the system. 11. This module is for manufacturers, authorised representatives, importers and system or procedure pack producers to register to use EUDAMED and to receive their SRN. The Actors module ensures that all actors using EUDAMED, including Economic Operators (EO), have been authenticated. This SRN is a unique identifier used across the EU to identify the manufacturer in the EUDAMED system. EMDN codes are required when completing the device registration in swissdamed. ˜˚˛˝˙ˆˇ˘ ˘ ˆ˝ ˝ ˙˚ ˝ The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Nov 27, 2020 · With the first module on actor registration scheduled to go live on December 1st, the timing is appropriate to provide a comprehensive overview of what EUDAMED is and its interaction with quality EUDAMED is the IT system that will be made of 6 modules, among which the first one is the Actor registration module, 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 Eudamed registration process. The registration platform will be open from 1 December 2020 when this first module of the future European Medical Device Database will be launched – you can access the Actor Registration User Guide. ipkehj kkpp nqjn qsimgn evbi nfszjl duwhuv dqiv zcjca svifpoo