Electronic Instructions for Use (e-IFUs) for Medical Devices

Introduction

Electronic Instructions for Use (E-IFU) have become an integral part of the Medical Device landscape in Europe. As regulatory requirements tighten and technology advances, manufacturers must ensure their E-IFUs are compliant, accessible, and informative. EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (e-IFU) is regulated by Implementing Regulation (EU) 2021/2226.

Essential Requirements:

The electronic instructions for use (e-IFU) must comply with the core requirements set forth in the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). These ensure the devices remain safe, effective, and easily accessible. According to the Implementing Regulation (EU) 2021/2226, manufacturers may replace traditional paper instructions with electronic ones if certain conditions are fulfilled. These conditions apply to devices within specific categories:

• Implantable and active implantable Medical Devices, along with their accessories.
• Fixed-installed Medical Devices and their accessories.
• Devices with integrated systems that visually display instructions (such as ultrasound machines).

This approach maintains clarity and accessibility while embracing modern digital solutions.

The most important changes introduced by the new Implementing Regulation 2021/2226 are:

1. Software
2. Risk assessment
3. E-IFU on the manufacturer’s website: If an e-IFU is provided, it must be available on the manufacturer’s website (Article 5(11).?
4. E-IFU indication on device labels: According to Article 6(1), manufacturers must now clearly indicate in the labeling that the instructions for use for the device are supplied in electronic form instead of in paper form.

Harmonized Standards:

Adherence to harmonized standards, such as IEC 62304, can help manufacturers demonstrate compliance with regulatory requirements.

What regulations and guidance apply to e-IFU?

There are a few regulations and guidance documents that one needs to be familiar with if they are planning on selling your Medical Device or in vitro diagnostic (IVD) in the US or the EU.

In the EU, the requirements for information to be provided with the device, which covers eIFU, can be found in Clause 23.1 (f) Annex 1, Chapter III of EU MDR: However, Regulation 207/2012 has recently been repealed and replaced with Regulation 2021/2226. This new regulation aligns with EU MDR and lays down the rules for when and how manufacturers may provide eIFU in a non-paper format.

Instructions for use may be provided to the user in non-paper format (e.g. 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.

In the US, FDA addresses IFU in 21 CFR Part 801.5. Unfortunately, section 801.5 says nothing about electronic delivery, and there is little formal guidance on their use, compared to the EU regulations.?

Still, FDA does allow manufacturers to deliver eIFU rather than in paper form. Section 352(f) of the Federal Food, Drug and Cosmetic Act states:

Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.

Special case: IVDs and products without an intended medical purpose

(IVDR (Regulation 2017/746) Annex I, Chapter III, 20.1.f)

Implementing Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic medical devices (IVDs). For them, the IVDR governs when manufacturers may deviate from the paper form:

“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.”

Emerging Trends in E-IFU

The Medical Device industry is continually advancing, and e-IFUs are evolving alongside it. They can be integrated with other digital health solutions, such as patient portals and remote monitoring systems. Additionally, Artificial Intelligence (AI) can be employed to personalize e-IFU content and enable intelligent search features. For software defined by the MDR, the use of an electronic format is allowed, even if the product is used by non-professionals. In the case of medical software, e-IFUs are permitted when the product is used by laypersons, provided the instructions are embedded within the software itself rather than supplied in paper form, as stated in Article 3(3) of Implementing Regulation (EU) 2021/2226. Blockchain technology can further enhance the security, integrity, and traceability of e-IFUs.

Conclusion

Electronic instructions for use (e-IFU) are essential for ensuring the safe and effective use of Medical Devices. By adhering to regulatory standards, implementing best practices, and keeping up with new trends, manufacturers can create e-IFUs that cater to the needs of healthcare professionals and patients. The Implementing Regulation 2021/2226 has replaced the previous EU Regulation 207/2012, which was also applicable under the MDR. However, Regulation 207/2012 continues to apply to devices placed on the market or put into service during the transitional.

Visit our website for more details: https://mavenprofserv.com/