COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form

Ref. Ares(2025)1431476 - 21/02/2025 EUROPEAN COMMISSION Brussels, XXX PLAN/2024/2826 (POOL/D3/2024/2826/2826-EN feedback.docx) […](2025) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form (Text with EEA relevance) This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission. COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC1, and in particular Article 5(6) thereof, Whereas: (1) Commission Implementing Regulation (EU) 2021/22262 limits its application to certain medical devices and their accessories. (2) The results of a survey on replacing paper-based...