Revised Regulation on Instructions for Use in Electronic Form Expands Its Scope of Existing Provisions

The original Regulation governing the provision of instructions for use for medical devices in electronic form was limited in its scope. Although the scope of the Regulation has been expanded, the medical devices in relation to which instructions for use in electronic form were permitted remained limited.

This scope of such supply has now been substantially expanded. With some exceptions, Commission Implementing Regulation (EU) 2021/2226 expanded the medical devices in relation to which instructions for use may be provided in electronic form to all medical devices and their accessories falling within the MDR that are intended for professional use.

This includes devices without an intended medical purpose listed in Annex XVI to the MDR provided these are intended for professional use. Commission Implementing Regulation (EU) 2025/1234, which entered into force on Wednesday 16 July 2025, clarifies the relevant provisions of Articles 5 to 7 of Commission Implementing Regulation (EU) 2021/2226 laying down the requirements that must be fulfilled for instructions for use to be provided in electronic form for permitted medical devices.