{"id":34494,"date":"2025-07-17T14:13:02","date_gmt":"2025-07-17T12:13:02","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34494"},"modified":"2025-07-31T09:41:13","modified_gmt":"2025-07-31T07:41:13","slug":"regulation-eu-2025-1234-extends-eifus-to-all-devices-for-professional-use","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/07\/17\/regulation-eu-2025-1234-extends-eifus-to-all-devices-for-professional-use\/","title":{"rendered":"Regulation (EU) 2025\/1234 Extends eIFUs to All Devices for Professional Use"},"content":{"rendered":"

Instructions for Use (IFU) are a key component of medical device labelling in the European Union<\/strong>, essential for product safety and efficacy.<\/p>\n

It is precisely in the context of managing this documentation that, on June 26, 2025, Implementing Regulation (EU) 2025\/1234<\/strong>, amending the previous Implementing Regulation (EU) 2021\/2226, was published in the Official Journal. Thanks to this initiative of the European Commission, electronic instructions for use (eIFU)<\/strong> will be extended to all medical devices intended for professional use: <\/strong>a welcome change that promises to reduce the burden on manufacturers through the greater use of digital tools.\u00a0 The new provisions will enter into force on July 16, 2025<\/strong>.\u00a0 <\/strong><\/p>\n

Please note that the instructions for use (IFU), whether in paper or electronic format (eIFU), are needed to provide users with all the information they need to use the device safely and effectively.<\/p>\n

What changes with Regulation (EU) 2025\/1234?<\/h2>\n

All devices intended for professional<\/strong> use, by healthcare professionals, can now only<\/strong> be accompanied by instructions in electronic format (eIFU)<\/strong>, without the need for a paper version.\u00a0 It is very important to emphasise ‘professional use’: traditional paper IFUs remain mandatory if the product is intended for the lay user.<\/p>\n

Also relevant is the fact that Regulation 2025\/1234 also applies to non-medically intended devices listed in Annex XVI of the MDR<\/strong><\/a>, provided they are intended for professional use.<\/p>\n

Furthermore, devices subject to the transitional provisions of the MDR, known as Legacy Devices, are also included.<\/p>\n

This change represents a major step forward for manufacturers, who will now be able to manage documentation in a more streamlined and flexible manner.<\/p>\n

However, beware of the dual purpose of a medical device: if a professional device can reasonably also be used by a patient or end consumer (lay user<\/strong>), instructions addressed to the latter must be provided in paper form<\/strong> (Article 3, para. 2 of Regulation 2025\/1234).<\/p>\n

Further key changes<\/h2>\n

The main changes in addition to the previous ones are listed below. The main changes include:<\/p>\n