Eudamed guidance. ) The Basic UDI-DI is the access key for device-related information entered in the EUDAMED database. The pages collate information about the modules, including the user guide, technical documentation and guidance. Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) July 2022: MDCG 2021-13 Rev. Jun 2, 2020 · The document describes the legal and other connected rules – mainly arising from the EUDAMED database design – that are essential to understand before making decision on the Basic UDI-DI grouping. Each EUDAMED account is associated with one of the following actors: • Manufacturer • Authorised Representative • System/Procedure Pack Producer • Importer Each of these actors has a set of roles that are specific to each module in EUDAMED. However, 1) the requirements for manufacturers to report potential supply disruptions shall only apply from 10 January 2025, and 2) EUDAMED will only be mandatory once published in the Official Journal of the EU. Jun 6, 2019 · After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Introduction 1. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional; MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States; MDCG 2019-5 Registration of legacy devices in EUDAMED In the guidance document MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional, the Medical Device Coordination Group (MDCG) sets out how to apply certain provisions of the MDR that require the use of Eudamed. The purpose of this user guide is to help you navigate through the Notified Bodies and Certificates process of registering certificates module into EUDAMED. 1 EUDAMED. The obligation for placing the UDI carrier applies according to the following timelines: Device as per Regulation (EU) 2017/745 (MDR) Implantable devices and Class III devices Class IIa and Class IIb devices Class I devices Placing UDI-carriers EUDAMED’ and the Guidance ‘Registration of legacy devices in EUDAMED’ – MDCG 2019-5. 2 The XML bulk upload/download through EUDAMED UI. Guidance on classification of medical devices October 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The EUDAMED ID will have the same format and value as EUDAMED DI except the first prefix character. Recent Updates to the EUDAMED Timeline. 1 Introduction. incident in Eudamed. Important Notice – EUDAMED Launch Delay; Guidance on Qualification and Classification of Software; EU UDI FAQs; European Union Legislation – Issuing Entity Designation; European Union Medical Device Regulation; Guiding Principles for Issuing Entities Rules on Basic UDI-DI; Guidance on Application of UDI Rules to Device-Part of Products Mar 15, 2021 · MDCG Guidance. On 23 January 2024, the European Union published the latest regulation, “amending Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] as regards a gradual roll-out of Eudamed [European Database on Medical Devices], information obligation in case of interruption of supply and transitional provisions for Guidance is available on the preparation, submission and assessment of PSURs. The EUDAMED modules include: actor registration, unique device identifier (UDI) and device registration, notified bodies and certificates, clinical and performance studies, vigilance, and market surveillance. Each EUDAMED account is associated one of the following actors: manufacturer Several technical EUDAMED documents were published including; a data dictionary, MDR and IVDR data sets, an update to the 2018-1 guidance on Basic UDI and changes, electronic data exchange introduction, definitions, and guidelines. 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. Nov 3, 2023 · The overarching goal of EUDAMED is to strengthen regulatory oversight and patient safety within the EU. 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). SRN이란, EUDAMED 및 관련 공식 문서 및 관련 보고서에서 모든 경제 운영자(Economic Operator)를 고유하게 식별하는 단일 등록 번호(Single Registration Number) 입니다. Manufacturers must register both themselves and their devices into EUDAMED; however, only Economic Operators (Manufacturers, Distributors, Importers and Authorized Representatives) can currently register in EUDAMED to obtain what is referred to There is the EU guidance on practices in the transition to fully availability of EUDAMED for MDR and IVDR (MDCG 2021-1, MDCG 2022-12). The EUDAMED database is built around 6 interconnected modules and a public website. with a set of characters. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. obtained an 'SRN' (Single Registration Number)). Input from stakeholders was taken into account. 1 min read; News announcement; New information published by the Commission expands upon guidance issued in April 2019 regarding Eudamed registration for legacy devices; the term “legacy device” pertains to any medical device or IVD with valid CE Mark certification under existing European Medical Device Directives, and that may remain on the European Union market after The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. EUDAMED has been delayed since 2020 and reporting in EUDAMED has been voluntary. EUDAMED DI: B-BEMF000000106CR023335WE EUDAMED user guide 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. EUDAMED will be made up of 6 modules (of which, not all are currently available) and will be used for different purposes as shown in the table below. The present MDCG guidance describes in detail the alternative solutions to be applied by all the parties involved in operations with medical devices in order to comply with the regulatory requirements on information exchange set forth by the new Regulations. 관련 안내자료와 도움이 될만한 사이트를 정리해 보았습니다. A system or a procedure pack that is a device in itself has to be registered by a Manufacturer (MF) and is not considered as a system or procedure pack to be registered by a System/Procedure pack producer (PR). The MDCG 2019-4 guidance document provides more information on this subject. This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. 4 MDCG guidance 2021-25, Regulation (EU) 2017/745 - application of MDR requirements to legacy devices [ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC October 2021 5 See section 2. Get a summary of the requirements medical device companies will need to follow when establishing EUDAMED nomenclature systems under the new EU MDR and IVDR. Registration of devices. Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator. EUDAMED is the database of Medical Devices available on the EU Market. 1 “Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional” lists affected articles of the MDR 2017/745 and provides practical steps until EUDAMED is functionally. For such products whose maximum number of reuses is determined, a change to this - data element will require the allocation of a new UDI-DI. Jul 16, 2019 · Article 88. Being a European concept, the Basic UDI-DI guidance provides useful information for stakeholders outside of the EU. Each EUDAMED account is associated one of the following actors: manufacturer Jun 10, 2021 · The guidance is a temporary support and recommendation to sponsors until the EUDAMED module for clinical investigations is fully functional from May 2022 which coincides with the Date of Application of the new in vitro diagnostic medical devices regulation (Regulation (EU) 2017/746). According to Article 73 of the MDR, all applications or Apr 25, 2024 · Extend the IVDR transition period for legacy devices; Introduce a gradual rollout of EUDAMED, which will make some registration modules mandatory early; Require manufacturers to report potential disruption to supply of critical products (including discontinuation) May 3, 2021 · Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional . The updated IVDR transition plan also features two new priority actions in existing sections. Mar 30, 2022 · eu mdr/ivdr의 eudamed에 대해 이제 막 알아보는 단계입니다. 1. TITCK will review EUDAMED actor registration applications. Instead, the registration should be modified as needed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional. obligations of operators’, MDCG guidance4 and other documents covering the UDI requirements5. Registration of MDR compliant devices on Eudamed will be voluntary before that date, when the Eudamed module on device registration is ready, hopefully in September 2021. ” “Whether the authorized The on-going guidance development document summarises the on-going guidance documents and deliverables of MDCG subgroups. Guidance is also available from the Medical Device Coordination Group: MDCG 2021-27 Rev1 Questions and Answers on Articles 13 (Importers) & 14 (Distributors). It is advisable to Apr 15, 2019 · The EU@s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed. 14. Annex XVI products; Borderline and Classification; Class I Guidance is available on the preparation, submission and assessment of PSURs. Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Apr 19, 2021 · The Summary of Safety and Clinical Performance (SSCP) is a regulated document which will be validated by the Notified Body (NB) during technical conformity assessment and made publicly available on Eudamed, the European database on medical devices. number shall be provided to the UDI Database in EUDAMED and in addition, reflected in the instructions for use in accordance with Annex I, GSPR 23. Questions & Answers A. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified Nov 6, 2021 · The TITCK Department of Medical Device Registration and Coordination announced on 18 October 2021 that the Guidance has been translated into Turkish, and in this context, economic operators are obliged to register with the EUDAMED Actor registration module in line with the Guidance. New EUDAMED Dates Jul 10, 2019 · Article 37. ’ Therefore, EUDAMED should be continually updated and maintain current Jan 21, 2021 · European Commission Issues New Guidance On Eudamed Medical Device Database Nomenclature January 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. For the most current understanding of EUDAMED’s deadlines, please read: EUDAMED Gradual Rollout (starting 2025) Until EUDAMED is mandatory, the registration requirements under the old Directives (MDD/AIMDD/IVDD) continue to apply. UDI-DI 1. Mar 24, 2022 · This site is managed by: Directorate-General for Health and Food Safety Jul 10, 2019 · Article 29. a specific guidance is intended. The Medical Device Coordination Group (MDCG) of experts have published guidance on a range of topics including the following: Borderline and classification; Clinical investigations and evaluations; Covid-19; Custom-made devices; EUDAMED; European Medical Device Nomenclature (EMDN) Implant cards; In Vitro Diagnostic medical devices (IVDs) May 3, 2021 · This is taking for granted that the current goal of 26 May 2022 for a fully functional Eudamed database will be met. ; MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Eudamed Guidance documents - Alysidia EUDAMED is the European Database on medical devices. The guidance notes that there are several entry points for inputting and downloading data into the Eudamed database: The user interface EUDAMED. 2. MDCG 2020-16 Rev. 2 days ago · The European database on medical devices (EUDAMED) is projected to be fully functional in 2027 following a gradual rollout starting in 2025. Jul 10, 2019 · Article 33 European database on medical devices 1. Further guidance Please be aware that this manual does not provide guidance, clarifications or recommendations for complying with the legislation. Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report Jul 9, 2024 · The amending regulation technically enters into force immediately. Technical considerations and guidance for managing UDI data to meet the deadline. It will start with 'D' instead of 'B'. For a wider understanding on how to use the platform, visit the EUDAMED Information Centre. 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. ” Under certain conditions, a System/Procedure Pack ‘Producer’ may become a ‘Manufacturer’. Its purpose is to strengthen market surveillance and transparency in medical device field providing to competent national authorities with quick access to information. EUDAMED Actor module user guide – for economic operators EUDAMED Actor module User Guide – for Economic Operators Introduction 6 1. Each user may have multiple accounts but can access EUDAMED with only one account at a time. Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report Jul 26, 2022 · The MDCG 2021-1 Rev. 3 User rights & profiles Each user has EUDAMED1 or more account(s) but may access with only 1 account at a time. EUDAMED user guide. Aug 9, 2024 · MDCG 2021-1 Rev. 3 User rights & profiles Each user has 1 or more account(s) but may access EUDAMED with only 1 account at a time. 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. 1: EC: EUDAMED: 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: EC: MDCG 2019-4 Timelines for registration of device data elements in EUDAMED: EC Eudamed Guidance documents - Alysidia EUDAMED is the European Database on medical devices. The UDI-DI/Device module of EUDAMED is used for this purpose. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. 4 - Publication date: Mon Apr 15 09:02:11 CEST 2019 - Last update: Mon Apr 15 09:02:34 CEST 2019 EUDAMED’ and the Guidance ‘Registration of legacy devices in EUDAMED’ – MDCG 2019-5. . As the first step, EUDAMED must pass an independent audit and be deemed fully functional. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). See Annex III of this document for more information. Oct 14, 2021 · Countries available in EUDAMED. Mar 19, 2021 · EUDAMED Alternative Solutions. The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. Where the number of items in a device package changes, is a new UDI-DI assignment required? A new UDI-DI assignment is required whenever there is a change that could lead to This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. For clinical investigations, solutions for the following affected MDR Articles are provided: Jun 9, 2023 · “For the purpose of this guidance and operations related to EUDAMED, the natural or legal person referred to in Article 22(1), 22(2) and 22(3) of the Medical Device Regulation shall be called the “system or procedure pack producer”. 2. Medical Devices Medical Device Coordination Group Document MDCG 2021-13 rev. This site uses cookies. MDCG 2019-5 Registration of legacy devices in EUDAMED Document date: Sun Apr 14 00:00:00 CEST 2019 - Created by GROW. EUDAMED will contain a living picture of the lifecycle of all products being available on the EU market. The MDCG 2021-1 guidance document provides helpful tables that cross reference different articles within MDR and provide guidance on how to meet these requirements in the absence of a fully functional Eudamed. 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 […] Jan 25, 2022 · EUDAMED’s 6 modules: an overview. 1. Guidance on UDI for systems and procedure packs – MDCG 2018-3 Rev. EUDAMED also contribute to the uniform application of the Directives. 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024. May 7, 2018 · The recent medical device nomenclature guidance (MDCG 2018-2) offers information for creating a nomenclature system within the EU. Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) July 2022 MDCG 2021-13 Rev. 1 day ago · “The manufacturer and authorized representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed upon by the parties. These are legally non-binding guidance documents, whose main purpose is ensuring uniformity in the application of the regulations. For further information on the EUDAMED DI format please consult the Format of the EUDAMED DI identification number document. This will allow bulk upload of existing information by uploading the XML files through the User Interface. The purpose is to increase transparency, including providing better access to information for the general public and healthcare professionals, as well as improving collaboration between different EU countries. D. For further information on EUDAMED, please visit the medical devices section of the European Commission website. Each EUDAMED account is associated one of the following actors: manufacturer Publication of MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices). ACTORS INVOLVED? Several technical EUDAMED documents were published including; a data dictionary, MDR and IVDR data sets, an update to the 2018-1 guidance on Basic UDI and changes, electronic data exchange introduction, definitions, and guidelines. EUDAMED restricted. DDG1. Actor module, SRN, GMDN, EMDN, CND Code등 관련된 용어들도 있는데 아직은 낯설기만 합니다. Criteria for EUDAMED Launch. e. Jul 17, 2024 · EUDAMED medical device and IVD registrations do not expire. Jun 21, 2023 · The European Commission published a new EUDAMED user guide about the registration of certificates. Jul 11, 2022 · This delays EUDAMED by another year. In addition to the requirements to connect to EUDAMED, the User will need to provide (upload) the data in XML format to EUDAMED. WARNING. This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. For more specific information regarding the correct Jun 18, 2024 · The EUDAMED user guide was updated in February 2024 (EUDAMED user guide – Notified Bodies & Certificates (v 2. first paragraph on the meaning of the term device _. This format is a legal requirement for both nationally authorised products and centrally authorised products. SRN은 EUDAMED에 의해 생성되고 EUDAMED에서 Actor 등록 요청을 검증한 관계 당국에 의해 EUDAMED를 통해 발행됩니다. EUDAMED public. MDCG is preparing guidance on "appropriate surveillance" by notified bodies for publication in the third quarter. 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). 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. Subsidiaries and subcontracting. 1 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. Apr 13, 2022 · As with the legacy device document, the Eudamed guidance is at the consultation stage and has a second quarter publication timeline. Which national competent authorities will be registered in EUDAMED Actor module. Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and Nov 6, 2021 · The TITCK Department of Medical Device Registration and Coordination announced on 18 October 2021 that the Guidance has been translated into Turkish, and in this context, economic operators are obliged to register with the EUDAMED Actor registration module in line with the Guidance. 1: EC: EUDAMED: 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: EC: MDCG 2019-4 Timelines for registration of device data elements in EUDAMED: EC MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) MDR EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The full functionality of EUDAMED requires the availability and full operation of all six of its modules and the MDR provides that the obligations and requirements relating to EUDAMED apply from the date corresponding to six months after the date of publication of a notice of full functionality. 1 3. The System/Procedure pack producer (PR) is responsible for the registration of System/Procedure packs in EUDAMED. After this occurs, it will be published in the Official Journal of the European Union (OJEU). Caution Please note, however, that each member state regulates how to deal with the obligations of the MDR (which are related to the EUDAMED) as long as the EUDAMED is not yet fully functional. Guidance documents. 4 (n). After OJEU publication, a six-month transition period will commence. Jan 15, 2021 · The EUDAMED Vigilance module, expected to be released in June/July 2021 (see previous Tech Letter on EUDAMED – overview and timeline), will serve notably for the reporting of serious incidents Jul 4, 2020 · The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. 1 Aug 30, 2023 · This guidance document Guideline MDCG 2021-1 lists in tabular form which alternative solutions are possible until EUDAMED is fully functional. EUDAMED timeline Notes 1 Minimum Viable Product (MVP) means that the system developed implements at least the minimum Medical Devices Regulations requirements and allows competent authorities and all stakeholders Oct 20, 2023 · What is Eudamed? Eudamed will provide an overview of the lifecycle of medical devices available on the market in the EU. For Regulation (EU) 2017/746 on in vitro diagnostic medical devices, a joint implementation plan was endorsed in principle by the Medical Device Coordination Group (MDCG). 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 is the European Database on medical devices. Jul 17, 2024 · EUDAMED is currently voluntary; its mandatory use date has been postponed. 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 This site uses cookies. intended for Manufacturers who are supposed to have validly registered in EUDAMED (i. A. EUDAMED is structured around six interconnected modules and a public site: • Actor – user registration and management • UDI database and registration of devices Dec 16, 2022 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… 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. This post summarizes the general principles and the main 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. As per the current EUDAMED database design (The current EUDAMED database design is not final yet. Jan 9, 2020 · EUDAMED Actor module user guide – for economic operators EUDAMED Actor module User Guide – for Economic Operators Introduction 6 1. Here are some link to better understand UDI and EUDAMED Document Short summary Author […] This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. Trend reporting. The national competent authorities from EU 27, Iceland, Liechtenstein, Norway and Turkey are registered in EUDAMED as well as the UK competent authorities in respect of Northern Ireland. Regulation \(EU\) 2017/745 Jan 9, 2021 · The SRN guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED). Note that EUDAMED is designed to serve as ‘a living picture of the lifecycle of medical devices that are made available in the European Union (EU). Mar 1, 2021 · The European Commission@s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system. ptgkmmgpnbfmzxqqrlcqqxiisdxhltqkznogfmfxiqxkhyhq