Commission Implementing Regulation (EU) 2021/2226 (2) limits its application to certain medical devices and their accessories.
The results of a survey on replacing paper-based instructions for use by electronic instructions for use the Commission carried out from 1 August to 10 October 2024 show a clear preference, among healthcare professionals, for receiving instructions for use in electronic form than in paper. Providing instructions for use in electronic form helps the health sector deliver better and faster solutions.
The scope of application of Implementing Regulation (EU) 2021/2226 should therefore be extended to all medical devices and their accessories covered by Regulation (EU) 2017/745 that are intended for professional users, including devices that fall under the transitional provisions provided for in Article 120 of Regulation (EU) 2017/745
(Text with EEA relevance)
25 June 2025