The evolution of the european regulatory framework regarding electronic instructions for use (EIFU) of medical devices: analysis of regulation (EU) 2025/1234 amending regulation (EU) 2021/2226

Since the adoption of Regulation (EU) 2017/745 on Medical Devices, the European Commission has embarked on a modernization effort to improve the communication of regulatory information in the European Union (EU). This initiative includes enabling manufacturers to provide instructions for use in a dematerialized or electronic format, a modern approach that leverages technological advancements to reduce environmental impacts and streamline document management. Adopted to modernize the strict framework established by its predecessor in 2021, Regulation (EU) 2025/1234, published on June 26, 2025, will come into effect on July 16, 2025, introducing significant changes informed by feedback from the industry and healthcare professionals to better align with technological advancements. This regulation broadens the scope of application, simplifies certain obligations, and integrates the European EUDAMED database into the management of electronic instructions for use. Understanding the key changes and implications of Regulation (EU) 2025/1234 is critical for medical device manufacturers in the European Union and Switzerland. This article provides an in-depth analysis of the developments introduced by Regulation (EU) 2025/1234, comparing them with the initial framework and examining their impact on manufacturers and professional users.

1. Initial Context: Regulation (EU) 2021/2226

The Implementing Regulation (EU) 2021/2226, adopted on December 14, 2021, established a rigid framework regarding the security, accessibility, and compliance of electronic instructions for use. It primarily aimed to reduce environmental impacts and costs while ensuring user safety. This framework mainly applied to:

• Active and non-active implantable medical devices and their accessories;
• Fixed medical devices;
• Devices equipped with integrated systems for displaying instructions for use.
  Electronic instructions were exclusively intended for professional users, with no reasonably foreseeable use by laypersons.
  Furthermore, strict safeguards were imposed, such as prior risk assessment, secure access compliant with the General Data Protection Regulation (GDPR), and archival of previous versions for a prescribed duration according to device type. Finally, devices without a medical purpose, as listed in Annex XVI of Regulation (EU) 2017/745, were explicitly excluded from electronic instructions.

2. New Features and Implications Introduced by Regulation (EU) 2025/1234

Regulation (EU) 2025/1234 introduces significant changes that transform the management of electronic instructions while having important operational implications for manufacturers and professional users. It is worth noting that these changes are not limited to the EU: The Swiss authority, SwissMedic, has promptly adopted the new EU requirements, enabling the electronic provision of instructions for use for devices intended for professional users in the Swiss market as well.

2.1 Expanded Scope and Terminological Clarifications

The new regulation extends the availability of electronic instructions to all medical devices and accessories covered by Regulation (EU) 2017/745, including those benefiting from the transitional provisions under Article 120 (“legacy devices”), as well as products without a medical purpose listed in Annex XVI of the regulation, provided they are intended for professional use. However, manufacturers must provide a paper version if use by laypersons (patients, caregivers, etc.) is reasonably foreseeable. Furthermore, terminological clarifications have been made: the term “medical” is removed from several provisions to explicitly include products without a medical purpose, and the definition of fixed devices has been reworded to maintain technical specificity while broadening their scope of application.

2.2 Integration into EUDAMED

To enhance transparency and traceability of device-related information throughout the European Union, manufacturers are now required to include the internet address (URL) for accessing electronic instructions in the UDI/Device module of the EUDAMED database when device registration becomes mandatory. This measure aims to harmonize the management of such information across Europe.

2.3 Simplification of Obligations

The regulation eliminates certain requirements deemed redundant. For example, the evaluation by a notified body, previously required under Article 8 of Regulation (EU) 2021/2226, is no longer included, as this verification is already covered by the conformity assessment procedures set out in Article 52 of Regulation (EU) 2017/745. Likewise, the proactive obligation to inform users who downloaded electronic instructions has been removed. This simplification streamlines regulatory requirements while maintaining a high level of compliance. In parallel, manufacturers are now required to retain all electronic versions along with their publication dates and ensure their availability upon request for the prescribed retention periods.

2.4 Operational Implications for Manufacturers

The expanded scope and terminological clarifications provide manufacturers with the opportunity to standardize their document management by adopting uniform electronic formats, thereby reducing costs associated with paper production and facilitating rapid updates. However, this evolution requires the upskilling of segments less familiar with the stringent requirements of the medical industry. Managing both paper and electronic versions to meet market and recipient needs entails optimizing logistics and fostering cross-departmental collaboration among regulatory, marketing, and production teams. Integration into EUDAMED necessitates rigorous processes to ensure data consistency and timeliness. Manufacturers must also maintain robust document management tools to securely archive and access electronic versions. Finally, removing redundant obligations simplifies administrative burden but requires systems that uphold security, traceability, and accessibility of information.

3. Summary of Regulatory Requirements

To help manufacturers navigate regulatory updates, the following summary highlights the requirements introduced by Regulation (EU) 2025/1234:

• Conduct a documented risk assessment (Article 4).
• Establish a mechanism to provide paper instructions upon request, free of charge to users, within a maximum of seven calendar days (Article 5(3)).
• Include emergency medical information and startup instructions for devices with integrated systems displaying instructions for use (Article 5(4)).
• Continue to respect national language requirements of Member States (Article 5(11)).
• Retain historical versions of electronic instructions available on the website (Article 5(13)).
• Clearly indicate on the label that instructions are provided electronically and not on paper (Article 6(1)).
• Provide information on accessing electronic instructions and the minimum details required for such access (Articles 6(2)-(3)).
• Once the UDI/Device module in the EUDAMED database becomes mandatory, manufacturers must include the web address where electronic instructions can be accessed (Article 7(3)).

It is important to clarify that providing electronic instructions for use remains an option available to medical device manufacturers, not an obligation. Manufacturers may continue to provide instruction leaflets in paper format. However, those opting for electronic formats must demonstrate full compliance with the requirements established by Regulation (EU) 2025/1234.

Need Assistance?

At Efor, we support our clients through this complex transition by leveraging our expertise in regulatory compliance and digital transformation, particularly for the dematerialization and provision of electronic instructions for use (e-IFU), both in Europe and other international jurisdictions with specific requirements.

Our services include:

• Regulatory Analysis: Assessing the impact of new requirements on your activities.
• Technical Support: Designing and implementing centralized document solutions compliant with EUDAMED and tailored to your internal processes.
• Review and Updates: Adapting your quality management system and device documentation to ensure regulatory compliance.
• Training and Operational Support: Developing team capabilities on the new regulatory framework and optimizing organizational practices.

In collaboration with our experts, manufacturers can transform this regulatory evolution into an opportunity for modernization and competitiveness. Efor’s team is here to support you at every step of your compliance journey, integrating cutting-edge solutions along the way. Contact us today at : TechnicalDivision@efor-group.com.