Electronic ifu Click this link to view LSTPI-B Instructions for Cleaning, Sterilization, Inspection & Maintenance - ifu. 207/2012 has been applied, can be accessed here. Request a document Concept by IFUcare. Accessibility: eIFUs can be accessed from anywhere with an internet connection, making them more accessible than paper-based instructions. The EyeSustain Taskforce on Electronic Instructions for Use plans to advocate for e-IFU to regulators and countries that do not accept e-IFU via local ophthalmologist advocacy and partnerships with global eyecare ELECTRONIC IFU INFORMATION. These pamphlets are printed in multiple languages and, in the case of an IOL, significantly increase the size and weight of the packaging. 0. A well implemented eIFU system can help maintain or improve patient safety while reducing production costs and environmental burden. com, prima di ogni utilizzo, per accedere alla versione più aggiornata delle IFU. As i read the directive and come to know that only Article 9 applicable to us. GSPR General Safety and Performance Requirements 12. The MDR states: "(f) Instructions for use may be provided to the user in non-paper format (e. Requirements for electronic instructions for use Electronic Instructions for Use (IFU) To access an electronic IFU, please use the dropdown menus to select your preferred language, product and corresponding lot number Electronic IFU Information. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to Therefore, under Article 6, manufacturers must specify on their products’ packaging about the IFU being in electronic format and where it can be found. Electronic Instructions For Use. Through our Download Center, you This site allows you to consult and download the Instructions for use in electronic format (eIFUs) for JDentalCare products. Electronic IFUs (eIFUs) also exist, and the rules for them are laid down in Implementing Regulation (EU) 2021/2226. Electronic IFU Cleaning, Sterilization, and Disassembly Symbols Glossary Patient Information For ConMed instrument Instructions for Year 2022 opened with the new (and long-awaited) EU Regulation 2021/2226 on instructions for use (IFU) in electronic form for medical devices Electronic IFU in China. On December 15, 2021, the European Commission published in the Official Journal the new regulation This website provides you with the Instructions For Use (IFU) from our company medical devices. Global Regulatory Agencies outlined several rules that can be implemented. jdentalcare. Related Information Part no. Electronic IFU may be supplied in New Zealand but the sponsor must be able to provide upon request from a user a hardcopy of the IFU. On the Abbott eLabeling website you will find user information guides and product Instructions for Use (IFU). 0811. • Have a system in place to clearly indicate when IFU has been revised and inform each user of the device thereof if a revision was necessary for safety reasons. Electronic IFU Cleaning, Sterilization, and Disassembly Symbols Glossary Patient Information For ConMed instrument Instructions for Durabilité : ce que nous faisons, ce que nous offrons. In case of problems opening PDF files through the browser, you can download Adobe Acrobat Reader software through the following link: Adobe Acrobat Reader. Starting from April 1st 2020, you will find Regulation (EU) No 207/2012 on electronic instructions for use of medical devices already mentioned that ‘for some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users’. e-ifu. g. The Field Safety Notice will be sent to users who purchased products impacted Indicates consult instructions for use for an electronic instruction for use (eIFU) Caution To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness Introduction. Medical Device Regulation (MDR) requires manufacturers to provide detailed instructions for use (IFU) to guide proper and safe use of medical devices and products. This site provides Instructions for Use (IFU) documents intended for healthcare professionals and information for patients. 5 Lay User Lay User refers to individual who does not have formal training in a relevant field or discipline. Wir haben die Voraussetzungen für die elektronische Gebrauchsanweisung für Sie zusammengefasst. 30APR2024 NuVasive San Diego – FL Tissue License – Exp. 21 CFR Part 800-1299 deal with medical devices while requirements of 21 CFR Part 809. CONTACT US. 104-13 (May 22, 1995) and Government Paperwork Elimination Act, Pub. com (65) 6681-0000 Follow us on LinkedIn. Damit will die Europäische Kommission sicherstellen, dass das Sicherheitsniveau bei der Bereitstellung elektronischer Gebrauchsanweisungen mindestens genauso hoch ist, wie bei der Bereitstellung von Gebrauchsanweisungen in Papierform. Whether they can also be provided in electronic form (eIFU) is Paper-form IFU is required and additional electronic IFU is optional for home use devices. The European the Council as regards electronic instr uctions for use of medical devices THE EUROPEAN COMMISSION, Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing But an electronic IFU(33 (eIFU) stands to be more flexible and economical in the long run than traditional, printed IFUs. A number of IFUs are available in electronic format only and are not included in kit packaging. The Communiqué will have its legal ground Welcome to the KaVo Electronic Instructions for Use Download Center. 105-277, Title XVII (October 21, 1998), we have issued regulations and guidances news archive – varex imaging. What is your model number or product name? Find My Manual. electronic format IFU: - Over 88% of healthcare professionals would prefer to have the electronic IFU 1; - Over 90% of the hospital administrative staff/ hospital pharmacists would prefer to have eIFU for medical devices2; - 85% of users prefer to have instructions for use of their contact lenses and lens care products in digital format3. Electronic IFU in China. Date: [December 1. from the product box or blister labelling; Select the eIFU in your language We recommend that surgical manufacturers replace paper IFU with an alternative, electronic-IFU whenever possible for ophthalmic surgical products. Paper-form IFU is required and additional electronic IFU is optional for home use devices. ISO International Organization for Standardization 16. It is an integral part of the medical or IVD device. Pour ifm, la durabilité est plus qu'un mot à la mode. The legislation currently requires that a printed IFU, in multiple languages, is provided to each patient with each device. Rest of articles applicable to manufactures which provide the IFU in electronic Food and Drug Administration Welcome to the eIFU website of undefined, offering a seamless and compliant way to access essential product documentation, such as Instructions for Use. These pages list our product offerings in these areas. Abbott recommends the eLabeling be downloaded, printed, reviewed, and readily available for reference. Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) GHWP/WG1-WG2-WG3/F002:2023 6 / 10 1. Both MDR and FDA regulations permit e-IFU, although for MDR, this is limited to certain products. Please refer to the Use-By Date on the product packaging to find the Electronic Instructions for Use. 1 Regulation 2021/2226). At Alysidia, our professionals’ team helps medical device manufacturers all across Europe comply with EU MDR’s requirements. stryker. The Wij willen hier een beschrijving geven, maar de site die u nu bekijkt staat dit niet toe. The IFU documents on this site are valid only on the date printed. Johnson & Johnson Vision. Electronic IFU can take several formats including; files supplied with the device on read-only media, files downloadable from the internet, and help files displayed by the device. Under the general rule, electronic Instructions For Use (eIFU) are Electronic IFUs and other information on this website are considered valid on the access date. With the rapid evolution of technology and practices, eIFU Regulation I am slightly confused on when you can supply an electronic IFU instead of a paper IFU accompanying the product. In case of changes or updates to Instruction for use due to safety reason, the user will be notified by a Field Safety Notice (FSN) via email. Use this site to find electronic Instructions For Use (eIFU) and manuals of your Medtronic product. com Electronic IFU (eIFU) Electronic instructions for use ― instructions displayed in electronic form: • by the device (“help” systems, or graphical user interface (GUI)-based dialogues), or • contained in portable electronic storage media supplied by the manufacturer together with the device, or “instructions for use in electronic form(电子型使用说明)”是指设备以电子形式显示的使用说明，包含在制造商与设备一起提供的便携式电子存储介质中，或通过软件或网站提供。 制造商的哪些器械可以提供电子型使用说明. HOYA Surgical Optics Global Headquarters HOYA MEDICAL SINGAPORE PTE LTD. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Choose your Location. e. For online IFUs, obsolete versions of the IFU For best results, use the free Adobe@Reader to view electronic IFU. What are the. NOTE 1: Principles for lay person(s) may also apply to self-testing for an IVD medical Stay Ahead Of Regulatory Changes like the European Commission’s Survey on Electronic Instructions For Use (eIFUs) for Medical Devices. Electronic Instructions for Use (IFU) Symbols Glossary. European Countries Non-European Countries (Excluding the United States) Careers; Contact Us; There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including: 1. 4 of the MD Regulations, and must comply with all other applicable Australian laws. Introduction. This proposal is of a great importance for the industry and MedTech Europe will provide its contribution to the consultation. Through our Download Center, you have the option to download e-IFUs directly to your electronic device, or you can request to have a printed copy mailed to you. 2. 1. Display search results with a default set of facets. Languages. We welcome the extension of the [] Instructions For Use (IFU) information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken. Timeliness: eIFUs can be updated more easily and quickly than paper-based instructions, ensuring that Electronic IFU Information This site provides Instructions for Use (IFU) documents intended for healthcare professionals. SSchoepel Involved In Discussions. We provide an innovative tool to manage your IFU digitally and in full compliance with MDR regulation. e-IFU regulation Regulation (EU) Number 207/2012 on Electronic Instructions for Use 11. In the USA, requirements for IFU are put forward by the Code of Federal Regulations (CFR). Contact your healthcare provider if There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including: 1. Except for software and devices with screens, the IFU may reside on a website, and its The European Union has allowed electronic instructions for use (eIFUs) since March 2013 with Regulation 207/2012. com; Type in the REF or Re-Order No. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation An Electronic IFU for your Medical Device. 2). Regulation 4J of the Medical Device Regulations 2002 [as amended] [UK MDR 2002] on electronic instructions for use of medical devices allows manufacturers of certain types of However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU). 7200. É possibile richiedere una copia cartacea delle Arthrosurface Joint Solutions Electronic Instructions for Use Filter By: CLEAR FILTERS PRODUCT NAME Femoral Condyle Shoulder HemiCAP Talus Toe HemiCAP UniCAP ToeMotion WristMotion Hemi OVOMotion WristMotion Total PF Wave (PFXL) OVO WaveKahuna Hip HemiCAP PF Classic Inlay Glenoid Glenojet SpeedSpiral Toe DF ToeMATE BOSS SpiralUp KLS-Martin L. If you would like to request a printed version of an electronic IFU (eIFU), we invite you to contact us using your local free phone number provided in the link below. Instructions for Use (IFU) for medical devices have traditionally been paper-based but, with the advent of electronic Electronic IFU Information This site provides Instructions for Use (IFU) documents intended for healthcare professionals. C2P is an The Geistlich Pharma AG eIFU system ensures access to the IFU of all Geistlich products as electronic documents; You can also order eIFU as a hardcopy; Enter the eIFU System via ifu. P. 10 Biopolis Road, #04-01/06, Chromos, Singapore 138670 HSO. In a notification, Chinese authority has said only that eIFU should be consistent with approved IFU. The responsibility SFDA/MDS Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices (MDS – G41, of September 29, 2019) Electronic Instructions for Use – eIFU: For professional users of medical devices (including IVDs) – Anika’s Electronic Instructions for Use (IFU) website is intended for medical professionals to download Instructions for Use for products from Anika Companies. IFUcare is a service of QbD IVD | Qarad, the regulatory The Implementing Regulation (EU) 2021/2226 outlines the circumstances in which the instructions for use (IFU) for Medical Devices can be presented in electronic format instead of paper format. varex to participate in cjs securities 25th annual new ideas for the new year virtual conference; varex announces private offering of $125 million of senior secured notes But an electronic IFU(33 (eIFU) stands to be more flexible and economical in the long run than traditional, printed IFUs. Manufacturers had to rely on printed materials as the means of communicating product, safety, and Website support: support@ifucare. ETHICON. 24DEC2024 NuVasive San Diego – IL Tissue License Continued Electronic Instructions for Use (IFU) Our electronic Instructions for Use (IFU), for selected Xstrahl products to which European Regulation No. Billy Milly. • Shall indicate on the label that IFU is supplied in electronic form instead of paper The new law requires all IFUs to be provided in electronic-only. provides online access to Instructions for Use (IFU) and/or Cleaning and Sterilization Instructions which details the applicable safety information to ensure proper use of the medical devices manufactured by the KLS Martin Group. If you are a Medical Device Manufacturer in Europe looking for quality electronic IFUs for your medical devices, contact us to become an MDR compliant medical device Dear customer: Below you will find the applicable instructions for use (IFU) for Createch products. The e-IFU is our environmentally responsible solution to providing you access to instructions for our products. version history) should be documented for review by the TGA if requested. For electronic Instructions For Use, go to www. Electronic IFU Information This site provides Instructions for Use (IFU) documents intended for healthcare professionals. geistlich-pharma. La sezione "Altre versioni" nella pagina dei risultati della ricerca consente di consultare versioni precedenti delle Istruzioni per l'uso attualmente non valide. This website uses cookies. e-IFUs represent a significant leap towards enhanced efficiency, sustainability, and improved user experience. According to the IVDR. Dear All, Reading the new European Parliament regarding electronic instructions for use of medical devices 2021/2226 I was wondering what are now the differences between European and US (FDA) requirements about User Manual Australia@s Therapeutic Goods Administration (TGA) on Wednesday issued a new guideline detailing how manufacturers can comply with regulations for providing the instructions for@use (IFU) for a medical device in electronic or online format. With the rapid evolution of technology, MedTech Europe believes that the Regulation (EU) 2021/2226 (eIFU Regulation) no longer reflects the generally acknowledged state of the art as called out in the Medical Device Regulation 2017/745 (MDR); Annex I General Requirements, Art. Organize all your instructions for use and make them available to your customers DON’T BREAK THE SEAL Select the corresponding IFU version by comparing the "Valid as of" date of the IFUs with your product's manufacturing date, since specifications in IFUs may change for different versions of a product. These prescription-use products are intended for use by healthcare professionals only. Labeling – Part 801 General Labeling Provisions – Subpart A Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU) February 5, 2024. Why your views matter The feedback received through this consultation will contribute towards further strengthening of the regulatory framework related to IFU for medical devices and the format in which it is made available. For precise search Electronic IFU Information. medical devices and their accessories (covered by Regulation (EU) 2017/745) and fitted with a built-in system visually displaying the instructions for use. Though there are many advantages of using eIFU, complying with all the eIFU Regulatory requirements seems challenging. Contact Us. When the MDD came into law in 1992, electronic labeling (e-labeling) did not. This IFU search page provides you with Instructions For Use for Dako-branded products. @ Die EU-Verordnung 2017/745 (MDR) legt die allgemeinen Anforderungen an die Gebrauchsanweisung (instructions for use, kurz IFU) fest. Link to View/Download PDF. From this site you can view or print Instructions For Use (IFU) for the Small Headed Screw System, Large Headless Screw System, and RIPTIDE System devices. Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. Which country or region did you receive your device from your healthcare provider? Select. Accelerate your ability to achieve, maintain & expand market access for all products in global markets with C2P – Your key to unlocking market access, trusted by more than 300 of the world’s leading brands. The trend continues with more recent expansions in electronic IFU use in other markets1. It also establishes certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form relating to their Instructions for Use (IFU) and User Manual: From an application submission perspective, an electronic format is now accepted with its printed version. 1 apply to “Labeling of in-vitro diagnostic products. To request a paper IFU to be provided at no cost, please contact your local Alphatec Spine representative or Customer Service directly at orderprocessing@atecspine. • Shall make available all historical issued electronic versions of the IFU on the website. Available Websites for eIFU. com • Have a system in place to clearly indicate when IFU has been revised and inform each user of the device thereof if a revision was necessary for safety reasons. Note that according to the legislation, printed Instructions for Use and The user accesses the correct IFU via a key-code given on the label, which also contains basic information for identification and contact information to the manufacturer. You might know the European regulation 2021/2226 and 207/2012. S. B. 1: Under certain conditions, the MDR does not require instructions for use for medical devices or the IFU can be provided in electronic form. Product Name. . I guess most of the company's do provide . After you have downloaded the document, you can subscribe to receive an automatic e-mail notification when new IFU versions become available. enthält auch alle früheren Version der IFU; Die regulatorischen Hürden für den Wechsel zur eIFU sind hoch. From this site, download IFUs as PDF files free of charge. As highlighted by Yvonne and Oliver, there’s a lot to like about delivering instruction via an electronic channel. In this article, we are going to discuss about the requirements for eIFU mainly for the EU market, based on the Commission Implementing Regulation (EU) 2021/2226. In China manufacturer could use eIFU in a wide product group independent of professional user or implant. Instructions for use may be provided to the user in non-paper format (e. Privacy EyeSustain, in collaboration with the Medical Devices Manufacturing Association, sent a survey to 227 US surgical instrument and supply manufacturers regarding their thoughts around electronic IFU (e-IFU) as a substitute for paper IFU. Sometimes, the channel might be the device itself. Instructions for Use (IFU) for medical devices have traditionally been paper-based but, with the advent of electronic technologies, the possibility of digitising IFUs for medical and in vitro diagnostic (IVD) devices was realised by some forward-thinking companies and approved by regulatory bodies. Regards, Sreenu . For most medical devices a print IFU must be provided. st, 201 9 ] Symbols Glossary Return to eIFU Symbols Glossary Symbols Glossary – English Symbols Glossary – German Symbols Glossary – French Symbols Glossary – Greek Symbols Glossary – Spanish Symbols Glossary – Italian Symbols Glossary – Bulgarian Symbols Glossary – Brazilian Portuguese Symbols Glossary – Turkish Symbols Glossary – Dutch Symbols Glossary – We would like to show you a description here but the site won’t allow us. The European Commission draft proposal for implementing regulation to replace the EU 207/2012 regulation for electronic Instructions for use (IFU) has been published for public consultation on 27 April. Sep 4, 2024. Leave this field blank The European Commission has made changes to rules governing the provision of electronic instructions for use (eIFU) for medical devices (MDs), as originally laid down in Regulation 207/2012. ; User-Friendly Interface: Our software is designed for ease of use, allowing your team to manage IFUs with minimal training. the current strategy of FDA is same to accept the electronic user documentation. Information in the electronic IFU must include all items specified in essential principle 13. Electronic IFU (eIFU) Electronic instructions for use - instructions displayed in electronic form: by the device ("help" systems, or graphical user interface (GUI)-based dialogues), or; contained in portable electronic storage media supplied by the manufacturer together with the device, or; online, through a manufacturer's website. ; For information downloadable from the internet, the State and Tissue Bank Licenses Tissue Bank Licenses NuVasive San Diego – AATB Tissue License – Exp. Some products have limited regional availability. Users should keep their Welcome to the KaVo Electronic Instructions for Use Download Center. Ortho Technology, Inc. This site provides eIFU documents for healthcare professionals. Find out more about how Xstrahl will work tirelessly for As an alternative to paper IFU, electronic instructions for use (e-IFU) can be accessed through websites linked through Quick Response (QR) codes on the package. Ob sie auch in elektronischer Form vorliegen darf (eIFU), regelt die Durchführungsverordnung (EU) 2021/2226. Changes implemented in each version (i. a植入和有源植入医疗器械及其配件; JDentalCare consiglia di visitare ifu. Timeliness: eIFUs can be updated more easily and quickly than paper-based instructions, ensuring that users 10. 01OCT2024 NuVasive San Diego – CA Tissue License – Exp. This The Regulation makes it clear that your packaging must clearly specify that the IFU is in electronic format and where it can be found. This will result in huge savings and burden reduction for your company. An e-IFU can be accessed by a Quick Response code on packages. Documents should be reviewed before using or implanting a device, or performing follow-up care. The Turkish Ministry of Health (“the MoH”) has recently shared a Draft Communiqué on the electronic instructions for use (IFU) of medical devices with the industry for comments and suggestions. Digital platforms may include desktop or laptop computers, smart phones, tablets, or the device itself. This in turn greatly reduces the price that manufacturer had to bear to print the IFU's to provide along with each device . Similarly, instructions for use are also not required under certain conditions for IVDs (see Fig. Welcome to Electronic Instructions For Use. Language. Reactions: Rocke. Saudi Arabia: Optional: MDS – G10: Guidance on Labelling Requirements for Medical Devices, Dated: 18-Jan-2015: Where the device is intended for use by lay persons, the IFU shall be provided in a paper format. Rather See more Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). IFU Instructions for Use 17. Regulation (EU) 2021/2226, even though recently published, only allows Instructions for Use are intended to provide detailed instructions for processing reusable surgical instruments manufactured by Stryker Orthopaedics. If you like more information on the eIFU contact us or download our Electronic Instructions For Use. , more information can be presented on a computer screen as compared to a smart phone screen). In a period characterized by rapid digital transformation and technological advancements, the adoption of Electronic Instructions for Use (e-IFU) stands out as a critical evolution in the medical device sector. Key Feature. Fig. Manufacturers of software covered by Regulation (EU) 2017/745 may provide instructions for use in electronic form too by the means of the software itself instead of in paper version. Regulation (EU) 2021/2226, even though recently published, only allows The year 2022 opens with the new (long-awaited) EU Regulation 2021/2226 on electronic instructions for use (IFU) for medical devices. OA Pain Management and Regenerative Medicines Electronic Instructions for Use Filter By: CLEAR FILTERS View All . According to the document, the medical device manufacturers intended to place their devices on the Saudi market are allowed to provide the instructions for use in an electronic format providing that the medical device in question is intended to be used by healthcare professionals, and the appropriate format of the IFU does not impact the use of IFUcare enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for use (IFU) out of product packaging and make them accessible online. in an electronic format (eIFU). You can search by lot (batch) number, code number, reference number, or part number. There is no rule in term of eIFU. 2021/2226 on Electronic Instructions for Use (IFU) for medical devices bimeri; Mar 5, 2024; EU Medical Device Regulations; Replies 8 Views 946. The electronic IFU must clearly state the date of release, and target regulatory jurisdiction and should be version controlled. On 15th December 2021, the new Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of Medical Devices (eIFU) has been published on the Official Journal of the European Union. If you need a physical copy of an IFU, you can request it by contacting Createch. We are seeking feedback on how IFU are provided, and whether electronic IFU (eIFU) should be made available in more flexible format. Companies may think that e-IFU is an easy way to go and reduces the financial burden on having to print copies of paper IFU, on the contrary, I think it adds another risk level to the product such as an obsolete version being Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. If a downloadable PDF version were available, surgical facilities could print 1 copy . GDPR General Data Protection Regulation 13. From this site you can view or print Instructions For Use (IFU) for the Cannulated Compression Headless Screw and Cannulated Screw Systems. However, unlike the MDR, the IVDR does not make this exemption Download Instructions for Use as well as documents on approved importers through our electronic IFU (eIFU) web portal. MENTOR Worldwide LLC. Electronic IFU Information. The Regulation Medical devices, perhaps more than any product, demand user manuals that are effective, efficient, and readily available. Other than the software and devices having screens, IFU can be instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex instead of in paper form. , Adobe c. the Council as regards electronic instr uctions for use of medical devices THE EUROPEAN COMMISSION, Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing ELECTRONIC INSTRUCTIONS FOR USE Multi-Adjustable Facemask ® Electronic Patient IFU D-00980 REV-0 The information contained in the IFU is believed to be valid and accurate. L. The responsibility resides with the user to ensure that the most current version of the IFU is used. There are currently two Fresenius Kabi websites that provide electronic instructions for use (eIFU) for the MedTech portfolio. For electronic Instructions For Use, go to For best results, use the free Adobe@Reader to view electronic IFU. (6) Regardless of the language obligations imposed on manufacturers by the law of the Member States, manu­ facturers who provide instructions for use in electronic For online IFUs, obsolete versions of the IFU must remain accessible to the public where appropriate. With electronic IFUs, the process of updating information is far less time-consuming and involves less waste. The move to electronic IFU (eIFU) for professional use devices started almost two decades ago in major markets like the US and quickly followed by Canada. 15OCT2024 NuVasive San Diego – DE Tissue License – Exp. An eIFU is the electronic version of a paper IFU provided with the device. This allows the manufacturer to update the instructions for use whenever there is a design change or a recommended change in the operation due to a risk identified post-market. • Shall indicate on the label that IFU is supplied in electronic form instead of paper The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. This site is intended for visitors from North America, South America, Africa, Asia, Europe, Latin America and the Pacific. contactus@hoya. Current Revision. com. 12 Rev. ; Real-Time Updates: With our View or download electronic Instructions for Use (IFU) for Parcus Medical products. E. Electronic IFU (e-IFU) refers to the electronic version of the IFU. This Regulation on electronic instructions for use (eIFU) of medical devices can be downloaded on our website. HSO eIFU Main V1. Watch Now About For medical devices, Fresenius Kabi AG may provide electronic instructions for use instead of or in addition to paper copies where allowed or required. Want to stay ahead of the curve with eIFU labeling for medical devices? Learn about the benefits and regulations here. The risk assessment includes, among other things, an evaluation of the level of knowledge and experience of the user %PDF-1. Procedures; Products; Education; Product Literature; This site is intended for visitors from Africa, Asia, Europe, Latin America and the Pacific. Welcome to the Terumo Cardiovascular IFU Library, your resource for electronic copies of Instructions for Use (IFU). For example, a dialysis machine with a 13-inch (33-cm We have started to provide the instructions for use (IFU) of our products. ; Users should always have the choice to obtain the content of the eIFU in paper form on request, without undue delay or within the time period specified in the risk assessment, and at no additional cost. MDCG 2023-3 - is it me or was the rug just pulled? Errek; Feb 15, 2023; EU Medical Device Regulations; Replies 7 Welcome to Instructions For Use The e-IFU website provides you with Instructions For Use (IFU) from Johnson & Johnson Medtech Companies I am a Healthcare Professional. The “e” in eIFU simply refers to the method of delivery for those instructions. Analytical cookies help us improve our website by providing insight on how visitors interact with our site, and necessary cookies which the website needs to function properly. We included a qualification flowchart to help determining if an eIFU can be provided instead of a paper IFU. This will result in huge savings and burden reduction for your 1. Electronic IFU e-IFU and eManuals Solutions. ”. With the rise in a digital media interaction, the idea of electronic-Instructions for use is becoming more popular. Human factors guidance on medical device eIFUs. The original legislation allowed manufacturers to provide paper-based instructions for use (IFU) for MDs and associated software electronically, usually on It can provide a great advantage to people if the electronic IFU is also provided in audio and video version . To eliminate this signi We are plan to provide the IFU in electronic form as well as paper form for our Class IIb X-Ray medical device. It is the user’s responsibility to use the most recently available eIFU from this website. 5 %âãÏÓ 1156 0 obj > endobj 1170 0 obj >/Filter/FlateDecode/ID[086B39B584881D4DA45526E1F8B973DA>98051D5E06F95649ABB3B811D24E76B9>]/Index[1156 29]/Info 1155 PV300_EN_0120 - STOJAN MEDICAL drastic reinterpretation of the role of the Instructions for Use (IFU) and the regulated method for which this information is passed along to end-users and patients. Electronic instructions for use (eIFU) The size of a digital format will likely be dependent on the platform from which it is being accessed (e. Website support: support@ifucare. Privacy Complete Regulatory Compliance: Our eIFU software is fully equipped to handle the EU MDR electronic IFU requirements, ensuring that all your documentation remains compliant with the latest regulations. Under the MDR 2017/745, electronic Instructions for Use (eIFUs) are allowed for the following types of medical devices: If they are for professional use and use by other persons is not foreseeable: Implantable and active implantable devices, Fixed installed medical devices and their accessories, and; With the rapid evolution of technology, MedTech Europe believes that the Regulation (EU) 2021/2226 (eIFU Regulation) no longer reflects the generally acknowledged state of the art as called out in the Medical Device Regulation 2017/745 (MDR); Annex I General Requirements, Art. This website provides Instructions for Use (IFU) documents for products offered by Novastep. To open an IFU, you must have a PDF reader installed (e. io. The eIFU website is intended for Healthcare Professionals only. HCL Hindustan Computer Limited 14. La gestion responsable de l'environnement et des ressources naturelles est fermement ancrée dans la philosophie d'entreprise, et les progrès réalisés sur la voie d'une production climatiquement neutre sont documentés dans les rapports réguliers sur la durabilité. Electronic IFU Cleaning, Sterilization, and Disassembly Symbols Glossary Patient Information For ConMed instrument Instructions for Paperwork Reduction Act of 1995, Pub. Sterilmed, Inc. Part # Description. Request printed copy of IFU Electronic IFU leaflets offer streamlined access, enhanced user experience, the ability to deliver multilingual content seamlessly, and significant sustainability benefits. Sep 24, 2014 Users may only be provided with electronic instructions for use if the risk assessment shows that the safety level is just as high as if the instructions for use were provided on paper (Article 5 Sec. Common human factors engineering (HFE) standards and guidance documents (such as IEC 62366-1, FDA’s HFE guidance, HE75) do not yet cover or provide specific advice on Title: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) Authoring Groups: Working Group 1 - Pre-market: General MD Working Group 2 - Pre-market: IVDD Working Group 3 - Pre-market: Software as a Medical Device . To obtain a hard copy, submit a no-charge purchase order through the standard ordering process. Electronic IFU Cleaning, Sterilization, and Disassembly Symbols Glossary Patient Information For ConMed instrument Instructions for Instructions For Use. It can be seen that the Draft Communiqué is based on the EU Regulation numbered 207/2012 of March 09, 2012 (“EU Regulation”). Cerenovus. Biosense Webster, Inc. Instructions for use are generally defined as the information a medical device manufacturer provides end users about the intended useof the device, its proper use, and any precautions they should take while using the device. Our technical library allows you to view and download all of the Technopath package inserts in in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website. 07 02/2020 STIHLER ELECTRONIC GmbH Fully read the instructions for use, including the warning and caution information, before you use ASTODIA. Not all products have documents included in this website. Yes, but some documents can be ordered only as part of a set. So please guide me applicable Articles of eIFU Directive EU 207/2012 to us. Symbols Glossary. An extension of the European legislation to include all professional The requirements for IFUs are laid down in the EU Medical Device Regulation (Regulation (EU) 2017/745). For example, a dialysis machine with a 13 MDA/GD/0026: REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES – Dated: 21 November 2022 Stated that: Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. IC Implant Card 15. Tile View List View. Every ophthalmic surgical supply, including IOLs, IOL cartridges, and viscoelastic syringes, is packaged with instructions for use (IFU). Failure to follow the warnings, cautions, and infor-mation on use can result in death or severe injury to the patient. Clinical indications of products published on the NuVasive website are subject to individual national regulatory approval. I am a Patient. , however, makes no warranty, either expressed or implied, as to the completeness of information in all possible conditions. kst jbdyh botk ffhe tilzg gxj mbg jqzel yyt hyrotk