Release date: 2014-06-12 The European Union's electronic instructions for use came into effect in March 2013. It is common for users of electronic devices or software to visit the manufacturer's website and download the latest product operating manuals, firmware or software as recommended. Electronically issued operating manuals or instruction manuals (IFUs), in addition to environmental protection, provide manufacturers and users with some of the more important advantages over paper. Manufacturers get cost benefits and speed time to market, while end users get more detailed and updated instructions. In 2003, the FDA approved the use of electronic labels for prescription medical devices used in US medical facilities. Since 2007, the European Union has issued guidelines for electronic instruction manuals (EIFU) for in vitro diagnostic equipment. 2 In March 2012, the European Commission issued the EIFU Regulations for certain types of medical devices, which came into force on March 1, 2013. 3 Applicable medical device type The European Commission's regulation EU 207/2012 on medical equipment EIFU applies to all EU member states and does not need to be converted into the laws of any member state. This regulation defines EIFU as a specification available on the website in the form of a removable electronic medium (eg, CD, DVD, USB stick) or displayed electronically on the product screen. For the latter two cases, the manufacturer is required to provide instructions on the website at the same time. This regulation allows the following types of equipment to use EIFU: • Active implantable medical devices and accessories that are embedded or programmed for use in prescribed active implantable medical devices covered by the European Directive 90/385/EEC (AIMDD). Implantable medical devices and their accessories for use in prescribed implantable medical devices covered by the European Directive 93/42/EEC (MDD). Fixed-mount medical devices covered by the EU Directive 93/42/EEC. • Medical equipment and accessories that are covered by the European Directives 90/385/EEC and 93/42/EEC and equipped with a built-in system to display the instruction manual. • Independent software covered by the EU Directive 93/42/EEC. The EIFU is only available if the target user of such equipment is a professional (such as a medical institution) and will not be improperly used by others. If the design of the medical device requires a portion of the instructions to be provided to the patient, the regulation requires that the portion be in paper form. Advantages and risks of medical equipment EIFU The EIFU can also contain video and audio files to demonstrate the installation, operation, implantation, and disposal of medical devices, enhancing the safe use of the device and helping to achieve the desired performance. Manufacturers can quickly and easily update EIFU based on post-marketing regulatory data to further enhance the safety of medical devices. EIFU dramatically reduces the cost and environmental footprint associated with paper and printing, while increasing time to market and avoiding costly recalls due to inaccurate information provided by paper IFU. The main risks associated with EIFU include delays in the provision or absence of instructions for use in medical institutions and insufficient safety provisions related to EIFU. Safety is the first principle This regulation allows for the additional provision of EIFU and as an alternative to paper instructions under specific requirements. Despite the high risk of this approach, most manufacturers are expected to offer EIFU instead of paper IFU. Therefore, this requirement is more troublesome. The manufacturer must clearly state on the medical device or on the sales package that the instruction manual is in electronic format rather than paper. If it is a fixed-mounted medical device, this statement should also be provided on the device itself. To date, there is no uniform symbol to declare the existence of EIFU, so the relevant symbols must be explained on the paper IFU or the booklet accompanying the medical device. In terms of content, the EIFU must meet at least the basic requirements of the instruction manual listed in MDD or AIMDD. Additional audio or video files may also be included to increase the usefulness of the instructions. The manufacturer shall implement and document the risk assessment of the EIFU's terms, taking into account at least the following: • Knowledge and experience of the target user. • The target environment in which medical devices are used. • An electronic resource entry when a user uses a medical device. • The impact of the EIFU website being temporarily unavailable. • Security measures to prevent electronic data and content from being tampered with. These risk assessments must be regularly updated with post-marketing data and should demonstrate that the EIFU provided maintains or improves safety levels compared to paper specifications. In addition to risk assessment, the EIFU regulations also set out certain obligations that manufacturers must fulfill to ensure patient safety and overcome the risks associated with the EIFU provisions, as follows: • EIFU is provided in all Member States where equipment is available, unless special circumstances are justified in the risk assessment. • Provide paper IFUs to users free of charge within seven calendar days upon request. • Provide information on foreseeable medical emergencies in the device or accompanying booklet. • If the instruction manual has been revised for safety reasons, each user should be notified. • Provide EIFU in a common format or provide hardware or software requirements information to display content. • Ensure that the IFU is still available for at least two years after the last production facility expires, and if it is an implanted device or a device with no clear expiration date, ensure that the IFU is still available for 15 years after the last production date. • Develop specialized website requirements such as hardware and protection against software intrusion to minimize downtime and display errors. Certification body assessment As part of the compliance assessment process, the regulatory body requires the certification body (NB) to review the EIFU for all devices except Class I equipment to verify compliance with EIFU regulations. Certification body audits are based on sampling methods that are applicable to equipment classification and complexity. Class III equipment EIFU is the most rigorous. The requirements of the regulations cover a number of matters, including content, access, risk analysis, inspection and verification, special obligations and website requirements. The above requirements are more based on a quality system (for example, a paper IFU is required to be provided within seven calendar days) and a Quality Management System (QMS) audit can be applied. Other requirements are technical in nature (for example, EIFU content itself and risk analysis). Although the NB approach may vary slightly, in EIFU approval, manufacturers can foresee approval as a mix of quality system and technical documentation assessments. NB is likely to want the EIFU website to function properly before making these assessments. As part of a continuous assessment visit, NB may audit post-marketing regulatory data to ensure that the transition to EIFU does not result in a reduction in equipment-related safety levels. Outlook When transitioning to EIFU, manufacturers must weigh the risks and benefits. Although the requirements of the EIFU regulations may seem cumbersome, manufacturers can achieve economic benefits and improve patient safety and satisfaction. The European Commission has laid the foundation for electronic labels. Although the scope of the EIFU regulations is limited to specific types of equipment, once the impact analysis is completed, the regulations will soon be included in other categories. Manufacturers who are prepared for EIFU transitions in business process and content management systems will have a competitive advantage. references Dr. Jayanth Katta is a Certified Manager and Equipment Specialist at BSI Healthcare in Grand Rapids, Michigan. Prior to joining BSI, he was the chief scientist of a startup medical device company in Philadelphia. He holds a PhD in Bioengineering from the University of Leeds, UK. Source: MEDTEC 5 Inch Biometric Tablet,Sim Card Fingerprint Tablet,Wireless 4G Tablet With Barcode Scanner,Fingerprint Scanner Rugged Tablet Shenzhen BIO Technology Co.,Ltd. , https://www.hfsecuritytech.com