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Registration of devices (incl. Procedure packs and Systems)NB/CRF module, for registration of Notified Body’s certificates and activities.CI/PS module, for registration of clinical Investigations under the EU MDR and performance studies under the IVDRVGL module, for reporting Vigilance cases and uploading post-market surveillance informationMSU module, for market surveillance activities by competent authoritiesUnder the EU MDR and IVDR, a device manufacturer or a procedure pack/system producer shall provide and continuously maintain up-to-date the following data in the EUDAMED database:Information about its Economic Operator role relative to the devices and procedures packs or systems placed on the market, per EU MDR/IVDR Annex VI, Part A. Upon successful registration of the manufacturer or procedure pack/system producer in EUDAMED, a Single Registration Number (SRN) is assigned to the entity. Details on how to register and maintain the manufacturer or procedure pack/system producer in EUDAMED’s Actor module are provided in the EU Commission’s EUDAMED User Guide – Economic Operators – Actor module. The so-called “core data elements”, a number of device-related data fields in EUDAMED that the manufacturer shall register together with the UDI-DI, per EU MDR/IVDR Annex VI, Part B. Core data elements include, for example: whether the product is a procedure pack or system, whether the device is sterile or single use or it contains latex or CMR substances.Details on how to register and maintain the information in the numerous fields of EUDAMED’s UDI module are provided in the EU Commission’s EUDAMED User Guide – UDI Devices.EUDAMED’s UDI helpdesk has been established to support Economic Operators in all aspects of the UDI system under the EU MDR/IVDR, i.e. UDI assignment, labelling and registration of devices.In practice, what do you need to do?If you have not started, make UDI a priority. The obligation for UDI assignment for non-legacy devices applies from the date of application of the EU MDR (i.e. 26 May 2021) or IVDR (i.e. 26 May 2022).The following steps will help you deploy your UDI project.8 steps to deploy your UDI projectLet’s see more in detail what each step entails.STEP 1 – Register with an EU-accredited agency for UDI assignmentUDI codes must be issued under the rules of an EU-accredited assigning agency. The EU Commission has designated the following entities, per Implementing Decision (EU) 2019/939:GS1 AISBLHealth Industry Business Communications Council (HIBCC)International Council for Commonality in Blood Banking Automation (ICCBBA)Informationsstelle für Arzneispezialitäten GmbH (IFA)Once registered with your agency of choice, you will be granted the company prefix, e.g. GS1 Global Company Prefix (GCP), the individual identification key that gives you access to the system. In case of changes in the legal status of your company (e.g. name change, merger, acquisition, spin-off), you must notify the agency.STEP 2 – Set up a UDI Management procedureThe manufacturer’s Quality Management System (QMS) should include a UDI Management procedure encompassing at a minimum the following aspects, in alignment with MDCG 2021-19:The structure of the manufacturer’s UDI-DIs (or Master UDI-DIs, MUDIs, for contact lenses) and UDI-PIs, including for third-party components that are medical devices or IVDs and for which. Udi magic download Udi magic professional full version Udi magic demo free download Udi magic v6.0 download Udi magic v4.0;

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You have a product that qualifies as a medical device under the EU MDR or as an IVD under the IVDR and want to understand how to implement the Unique Device Identifier (UDI) requirements. You have read the EU MDCG guidance documents on UDI, the EU Commission factsheet on UDI, browsed the new EU UDI Helpdesk, and are still unsure how to proceed. Here is everything you need to know.Replaces the version of July 2021Key takeawaysThe Unique Device Identification (UDI) system for medical devices, procedure packs, and systems under the EU MDR and for IVDs under the IVDR is mandatory. Only custom-made devices and investigational devices or IVDs for performance studies are exempt. Do not mistake the deadlines for affixing UDI carriers on the device label for an overarching deadline to assign UDIs. UDI assignment by manufacturers and procedure pack or system producers applies since the date of application of the EU MDR and IVDR.UDI management is a cumbersome activity that entails registration with a UDI assigning agency, UDI construction, core data management for EUDAMED registration, and labelling changes for UDI carriers. The process requires dedicated personnel and must be part of the quality management system.ContentWhat is UDI?What UDI codes exist under the EU MDR and IVDR?What is EUDAMED and how does it relate to UDIs?In practice, what do you need to do?What about “legacy devices”?Do UDI and EUDAMED apply in Switzerland?How Decomplix can helpFurther readingWhat is UDI?Unique Device Identifier (UDI) is a system intended to unambiguously identify medical devices at the generic group, model, and unit levels, and to allow rapid access to device-related information. Although medical device UDI requirements are already in place in many jurisdictions (e.g. USA, China, Brazil, South Korea, Saudi Arabia), there is no harmonized or universal application of UDIs. It is essential to verify the requirements in each geography of interest for the manufacturer. The present blog refers only to UDI requirements that apply to medical devices CE-marked under the EU MDR and IVDR. UDI is not required for:custom-made devices, investigational devices and IVDs for performance studies, or medical devices and IVDs manufactured and used within a healthcare institution.Simplified requirements apply to “legacy” devices, i.e. those still CE-marked under the former Directives. See chapter: What about “legacy devices”?Unique Device Identifier (UDI) is a system intended to unambiguously identify medical devices.There are 3 aspects of the UDI to be considered by a device manufacturer or procedure pack/system producer:The UDI codes, to be assigned (and maintained) by the manufacturer or procedure pack/system producer under the EU MDR or IVDR. Different types of UDI codes exist for a device model and unit. In addition, overarching UDI codes are required at the generic device group level. Special UDI rules apply to IVD kits, procedure packs/systems, and “configurable” devices.The obligation to assign UDI codes started from the date of application of the EU MDR (26-May-2021) or IVDR (26-May-2022).The data associated with a UDI code, to be uploaded (and maintained) by the manufacturer or procedure pack/system producer in the EUDAMED

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The manufacturer takes on regulatory responsibility.The process and criteria for grouping devices (including IVD kits and “configurable” devices) or procedure packs/systems under the same BUDI.UDI-PI labelling process (unless described in the general device labelling procedure), with particular consideration of the impact on production processes when direct device marking is required (i.e. for reusable medical devices). In addition, the IT and logistics aspects of barcodes need to be thoroughly considered.UDI-DI and BUDI change management process, i.e. criteria triggering a new code per EU MDR/IVDR Annex VI Part C and MDCG 2019-5 (unless described in the general change management procedure).UDI data master maintenance (process for establishing and keeping up to date the list of all BUDIs, UDI-DIs/MUDIs and their associated core data). In addition, a list of all UDI-DIs/MUDIs and UDI-PIs assigned shall be part of the device’s Technical Documentation, as required by EU MDR Article 27(7) and IVDR Article 24(7), and shall be subject to the same retention periods as for the Technical Documentation.The process for electronic transmission and consolidation of UDI data in EUDAMED and/or in any bespoke national databases (for example, swissdamed in Switzerland).Unless your company has experience with GTIN management, it is recommended that you appoint a dedicated individual, with regulatory and technical knowledge, to oversee the UDI process throughout the device lifecycle, particularly if AIDC needs to be implemented.STEP 3 – Assign the individual UDI-DIs or Master UDI-DIs (for contact lenses)The UDI-DI shall be assigned by the manufacturer at the device or procedure pack/system model level. Each level of packaging as commercially available (excluding shipping containers) shall be assigned its own UDI-DI. In the case of “configurable” devices (those that consist of several components which can be assembled by the manufacturer in multiple configurations), a configurable device UDI-DI shall be assigned to groups of configurations, i.e. the collection of possible configurations for a given device as described in the technical documentation.A Master UDI-DI (MUDI) shall be assigned to a given combination of contact lens design parameters, as defined by the manufacturer, including at least the ‘Base Curve’ and ‘Diameter’, and completed with other relevant parameters as indicated on the contact lens labelling.GS1’s Global Trade Item Number (GTIN) corresponds to the UDI-DI. The structure of the UDI-DI includes the company prefix, e.g. GS1 Global Company Prefix (GCP), the manufacturer’s internal code for the product (e.g. model number), and ends with 1 check digit that is automatically calculated by the system.An example of UDI-DI structure, built through the GS1 system is shown below.Example of UDI-DI structure based on GS1 systemEU MDR/IVDR Annex VI, Part C, sections 3 and 6 shall be considered when assigning/updating all UDI-DIs, as special rules apply in certain cases. In addition, any relevant standards and guidelines of the UDI issuing agency chosen would need to be followed.STEP 4 – Assign the Basic UDI-DI (BUDI)If you only have one or a few device variants, grouping their UDI-DIs on the basis of BUDI criteria (same risk class, same intended purpose, and same design/manufacturing characteristics) is a no-brainer.

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The UDI carrier shall be placed on the device itself, in addition to their packaging, and the UDI-PI shall remain readable after each reprocessing cycle.For contact lenses, the placement of UDI carriers (that shall include the Master UDI-DI) on the packaging shall comply with the requirements in the EU MDR, specifically space constraints and sales unit requirements in Annex VI, Part C, sections 4.2 and 4.3.For procedure packs and systems, the devices contained shall bear the UDI carrier on their packaging or on the device itself, except when the type of device is exempted from UDI carrier or is an individual single-use disposable device, the use of which is generally known to the users are not intended for use outside the context of the procedure pack/system.For “configurable” devices, the UDI carrier shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the configuration, and shall be identified as the configurable device UDI.For medical device software (MDSW), UDI placing criteria are clearly established in EU MDR/IVDR Annex VI, Part C. Three situations are possible:For MDSW delivered on a physical medium (e.g. CD, USB key), each packaging level shall bear both the human-readable and machine-readable (i.e. AIDC) representation of the complete UDI-PI. The UDI-PI applied to the physical medium containing the MDSW and its packaging shall be identical to the UDI-PI assigned to the system level software.For MDSW not delivered on a physical medium but having a user interface (e.g. mobile apps, webtools), only the human-readable interpretation (HRI) of the UDI-PI shall be required. It shall be provided on a readily accessible screen for the user in an easily-readable plain-text format (e.g. on the ‘about’ file, splash screens, or included on the start-up screen).For MDSW lacking a user interface (e.g. middleware for image conversion), the human-readable representation of the UDI-PI shall be conveyed through an application programming interface (API).In either case, the human-readable format of the UDI-PI shall include the Application Identifiers (AI) for the standard used by the issuing entity, to assist the user in identifying the UDI and determining which standard is being used to create the UDI.The UDI-PI code should be on each applicable packaging level, from the unit of use to the highest package level, except logistics units. It is important to highlight that the implementation of a UDI-PI carrier constitutes a complex project for a company and that it can only be successfully achieved when implemented in the company’s Enterprise Resource Planning (ERP) system and with dedicated IT and logistic resources. The costs and timelines of such a project need to be assessed as early as possible. Although not a EU MDR/IVDR requirement, verification of the barcode’s print quality is recommended to help ensure readability throughout the supply chain. To that end, standard series ISO 15415 provides relevant requirements for 2D and linear barcodes.STEP 8 – Maintain UDIs throughout the device lifecycleAs part of the manufacturer’s change management process, device changes shall be assessed in consideration of the criteria for. Udi magic download Udi magic professional full version Udi magic demo free download Udi magic v6.0 download Udi magic v4.0;