Are you looking to replace paper-based instructions for use by electronic instructions for use? Do you as a healthcare professionals prefer receiving instructions for use in electronic form than in paper. The Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 was brought forward to help health sector in delivering better and faster solutions.
Previously, Commission Implementing Regulation (EU) 2021/2226 limited application of eIFU to certain medical devices and their accessories. However, Regulation (EU) 2021/2226 extends scope of application to all medical devices and their accessories covered by Regulation (EU) 2017/745 that are intended for professional users. This also includes devices that fall under the transitional provisions provided for in Article 120 of Regulation (EU) 2017/745.
Further, this regulation also applies to devices without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745, provided that they are intended for professional use.
So, if your medical device with or without an intended medical purpose is intended for professional use, compliance with Commission Implementing Regulation (EU) 2021/2226 can be claimed.
Whereas for devices which are intended for professional use can also be used by lay persons such as patients, Regulation (EU) 2021/2226 mandates that the instructions for use intended for lay persons should be provided in paper form.
Submitting a Technical File for CE or UKCA marking is a demanding process for any medical manufacturer. However, when your medical device is sterile, the level of regulatory scrutiny intensifies exponentially.
Most Notified Bodies assign a dedicated expert to review the sterilisation aspects of your submission, entirely separate from the standard technical and clinical reviews. Because of this dual track assessment, ensuring your sterilisation documentation is airtight before you begin the submission process is not just best practice. It is critical to keeping your product launch alive.
How Advena Medical can help:
The requirement for information supplied with the product is clearly indicated in Annex I, Section 23 of MDR 2017/745. This Commission Regulation outlines the conditions for providing existing IFU information electronically. Certain content and website-related rules are indicated for devices where electronic IFU is provided in addition to paper IFU. Advena Ltd can help in understanding and navigating these requirements and providing guidance in developing an eIFU fully compliant with MDR 2017/745 requirements.
