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Il 7 luglio 2025 è stata adottata la Decisione di esecuzione (UE) 2025/1324, che modifica la Decisione (UE) 2019/1396 riguardante gli aspetti amministrativi dei gruppi di esperti in ambito dispositivi medici e IVD. Questo provvedimento prevede la nomina di un nuovo expert panel, con l’obiettivo di potenziare il supporto scientifico e tecnico offerto alla Commissione, agli organismi notificati e agli Stati membri. La misura punta a rendere le valutazioni cliniche più solide e uniformi, ad aumentare la trasparenza e a ridurre i principali colli di bottiglia nei processi di consultazione. Norme armonizzate false
25 March 2026

Harmonised Standards, Implementation and Enforcement Acts

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On 7 July 2025, Implementing Decision (EU) 2025/1324 was adopted, amending Decision (EU) 2019/1396 concerning the administrative aspects of expert panels in the field of medical devices and IVDs. This measure provides for the appointment of a new expert panel, with the aim of enhancing the scientific and technical support offered to the Commission, notified bodies and Member States. The measure aims to make clinical evaluations more robust and uniform, increase transparency and reduce major bottlenecks in the consultation processes.

On 26 June 2025,Implementing Regulation (EU) 2025/1234 (amending Regulation (EU) 2021/2226) on Instructions for Use (IFUs) that can be provided in electronic form instead of on paper was published in theOfficial Journal of the European Union, introducing new features.

Regulation (EU) 2025/1234 is an important update of Implementing Regulation (EU) 2021/2226, which governs the conditions for providing Instructions for Use (IFU) in electronic form for medical devices, and does not replace the previous Regulation, but intervenes to update and clarify several technical aspects in response to the digital evolution of recent years.

An important novelty introduced by Regulation 2025/1234 concerns IT security: the website on which the instructions are made available must be structured to ensure protection against tampering and unauthorised access, with backup and redundancy systems to guarantee the continuity and availability of information even in the long term (up to 10 or 15 years, depending on the type of device). These requirements intersect with cybersecurity requirements.

From the point of view of accessibility for health professionals, Regulation 2025/1234 better specifies how the consultation of UIFs must take place:access must be immediate, free and compatible with mobile devices. The UIFs must also be readable by assistive technologies, such as speech readers, in line with the European Accessibility Act (Directive 2019/882).

The aspects related to the choice of electronic format have also been strengthened. The regulation requires that the choice of electronic format be adequately justified in the risk assessment conducted by the manufacturer and that periodic audits of the accessibility, functionality and security of the website used be provided for. Furthermore, all changes and updates must be traceable and available in case of audits by the competent authorities.

Finally, no new harmonised standards were published in June 2025 for either the MDR (EU 2017/745) or the IVDR (EU 2017/746), the latest updates of which you can find on this page.

What can FTR ADVISOR do for you?

Do you want to know more or want to be sure if your electronic IFUs comply with the applicable European Regulations?

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