Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form

‘(1 Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to devices referred to in Article 1(4) of Regulation (EU) 2017/745 intended for use by professional users.’

‘(2 Where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form.’

‘(3 At the latest at the date from which the registration of devices in the UDI database referred to in Article 28 of Regulation (EU) 2017/745 applies in accordance with Article 123(3), point (d) or point (e), of that Regulation, as applicable, the manufacturer shall provide the internet address referred to in paragraph (2), point (e), of this Article to the UDI database in accordance with Part B, point 22, of Annex VI to Regulation (EU) 2017/745.’

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.