European Commission expands use of eIFUs
The European Commission has amended its implementing regulation to allow manufacturers to submit electronic medical device instructions for use (eIFU) to healthcare professionals for all devices, not just certain high-risk products. Products that may also be used by patients must continue to provide paper instructions.On 25 June, the Commission published an updated implementing regulation that significantly broadens what information can be shared via eIFUs to healthcare professionals. Under the previous regulation, only information for medical devices and their accessories that were for professional use could be submitted using an eIFU. More specifically, eIFUs were limited to certain devices that were meant for use by healthcare professionals and could not reasonably be used by patients, such as implantable devices and active implantable devices and their accessories, fixed installed devices, and certain software.
However, earlier this year, the Commission asked stakeholders if it should expand the regulation to other types of devices. Stakeholders agreed that eIFUs would be more convenient and effective for manufacturers and healthcare professionals. (RELATED: European Commission launches consultation on electronic instructions for use, Regulatory Focus, 24 February 2025)
Based on feedback from stakeholders, the Commission has expanded the scope of the regulation to all medical devices and their accessories covered under Regulation (EU) 2017/745 that are intended for professional users. This includes devices that fall under the transitional provisions in Article 120 of the Medical Device Regulations (MDR) and those that do not have an intended medical purpose listed under Annex XVI of the MDR.
However, the Commission also said that for devices that are intended for use by professionals and that could possibly also be used by a consumer, the instructions for use still need to be provided in paper form.
“From the moment in which the registration of devices in the European database on medical devices (Eudamed) becomes mandatory, manufacturers should provide to Eudamed’s Unique Device Identifier (‘UDI’) database the internet address under which the electronic instructions for use are accessible,” said the Commission.
Amended implanting regulation
