The European Commission has made changes to the rules governing the provision of electronic instructions for use (eIFU) for medical devices (MD), as originally foreseen in Regulation 207/2012.

Copy: The original legislation allowed manufacturers to provide hard-copy instructions for use (IFU) for MDs and associated software electronically, usually on digital hardware (USB sticks) or via a website.

The latest update, Implementing Regulation 2021/2226, repealed and replaced Regulation (EU) 207/2012, which was published in 2012 to enable the provision of eIFU.

Qarad has pioneered electronic labeling and eIFU services that meet and exceed EU, FDA and other international legislation since 2008. As a regulatory expert, Qarad always keeps a length ahead of proposed regulatory updates. As such, they immediately applied the new European provisions to their services and informed each customer of this change.

Qarad began assessing the future impact of the new regulations while they were still being drafted. With this head start and the flexibility of Qarad’s platform and services, they have ensured that their customers continue to benefit from the seamless application of the latest legislation to their information portals. medical devices.

Paper IFU and eIFU

IFUs and eIFUs are essential to ensure that medical devices are used safely, as they allow users to access critical medical device information. Therefore, the current rules require that the level of safety, longevity and security of eIFUs be superior or at least equal to those of IFUs.

Qarad monitors all current and proposed legislation, both in the EU and globally, and its eIFU platform and associated services have been designed to quickly make and implement changes.

eIFUs for medical devices are now widely distributed, with obvious benefits: a huge reduction in paper waste and costs. Additionally, it overcomes the logistical challenges of paper IFUs such as managing inventory and tracking IFU updates. But setting up a compliant eIFU solution is also a complicated process. Qarad simplifies this process.

Impact on the manufacturer

Manufacturers who wish to continue using eIFUs under the Medical Devices Regulation (MDR) should review the new implementing regulation 2021/2226 and consider how their current procedures align with the new requirements.

While no major changes have been made to the list of devices that can use eIFUs, the new regulations that allow manufacturers to provide eIFUs are:

  • Implantable and active implantable medical devices and their accessories
  • Fixed medical devices and their accessories
  • Medical devices and their accessories fitted with an integrated system for displaying the instructions for use

Manufacturers may provide operating instructions in electronic form rather than in paper form for listed devices only under the following conditions:

  • Devices and accessories are intended for the exclusive use of professional users.
  • Use by others is not reasonably foreseeable

For software, manufacturers may provide eIFUs within the software itself.

New rules

First of all, it is important to know why the eIFU regulation needed an update. The “old” eIFU rules were defined in terms of medical devices placed on the market at the time of the (Active Implantable) Medical Device Directives ((AI)MDD)[1]. Since 2017, the (AI)MDD has been replaced by the Medical Devices Regulation[2] (MDR). Since the MDR introduced many more and stricter rules, the associated regulations, such as the eIFU regulation, also urgently needed revision.

One of the rules introduced in the MDR is that in addition to documentation, which is shared with the healthcare professional, all implant manufacturers must also provide implant cards and information to the patient. According to the regulations, this patient information must be shared’by any means allowing rapid access to this information […]’. It is clear that eIFU would be ideal to serve this purpose.

Qarad’s eIFU website allows manufacturers to distribute information for both healthcare professionals and patients. Both are hosted on the same website, making data management easier for the manufacturer while maintaining a clear distinction between the respective HCP and Patient portals so that customers can easily obtain the documents relevant to them.

Transparency is another requirement of the new regulations. Effective systems and procedures must be in place to ensure that device users, having downloaded an eIFU from the website, can be notified of updates or corrective actions for their particular device.

Qarad will implement a subscription module in 2022, which will allow end users to easily subscribe to eIFU updates and related documentation. This new feature will be aligned with EU General Data Protection Regulation (GDPR) regulations.

Qarad’s eIFU website will be explicit in the consent obtained for the processing of personal data. The personal information entered will be limited to the strict minimum and kept for a period in accordance with the applicable regulations.

The requirements of Article 5 of Regulation 2021/2226 state that for devices with a defined expiry date, with the exception of implantable devices, the manufacturer must keep the eIFU available to users for 10 years after placing market of the last device, and at least two years after the end of the expiry date of the last device produced.

For devices without a defined expiry date and implantable devices, the manufacturer must keep the instructions for use available to users in electronic form for 15 years after the last device has been placed on the market.

All historical released versions of eIFUs should be available on websites. As such, version information is essential. On the Qarad website, version management is an integral part of the system and retroactive downloading of historical versions is a standard feature.

Article 6(3) deals with the elements to be included in the information on how to access eIFUs. Whereas previously Regulation 207/2012 required a unique reference and any other information necessary for the user to identify and directly access the appropriate eIFU, the new regulation requires the basic UDI-DI and/or the UDI-DI (Unique Device Identification – Device Identifier) ​​of the device, and any additional information allowing the identification of the device, including its name and, if applicable, the model.

Qarad’s eIFU platform customers have access to built-in configurable data fields that they can add to their portals to publish this type of additional critical information to their end users.

Article 7(2) adds two new requirements for websites through which eIFUs will be provided:

  • protected against unauthorized access and falsification of content in accordance with Article 4(1)(e)
  • Regulation (EU) 2016/679 (GDPR)

Security is an essential part of the Qarad eIFU system infrastructure and design. Qarad conducts quarterly scans against the Open Web Application Security Project (OWASP) Top 10 Threats and, at least, annual third-party penetration testing to verify the effectiveness of its controls and measures.

Qarad’s eIFU platform and service has been operational for over 13 years. Their system technology and capabilities are constantly evolving, ensuring their customers benefit from the latest hardware and software platforms.

More information

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[1] Respectively COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) and COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 on medical devices

2 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC