EU: Medical Devices Regulation – instructions for use in electronic format

 

The EU Commission is conducting a public consultation on a new regulation allowing instructions for use in electronic format under the Medical Devices Regulation.

Commission Implementing Regulation (EU) 2021/2226 as regards electronic instructions for use of medical devices currently restricts its application to specific medical devices and their accessories.

A survey conducted by the Commission from 1 August to 10 October 2024 on replacing paper-based instructions for use with electronic instructions revealed a clear preference among healthcare professionals for receiving instructions in electronic format rather than on paper. Providing instructions for use electronically enhances the efficiency of the healthcare sector by enabling faster and more effective solutions.

Therefore, the scope of Implementing Regulation (EU) 2021/2226 should be expanded to include all medical devices and their accessories covered under Regulation (EU) 2017/745 (Medical Devices Regulation) that are intended for professional users.

Once the registration of devices in the European database on medical devices (Eudamed) becomes mandatory, manufacturers should be required to submit to Eudamed’s Unique Device Identifier (‘UDI’) database the Uniform Resource Locator (‘URL’) where the electronic instructions for use remain persistently accessible.

Accordingly, Implementing Regulation (EU) 2021/2226 should be amended to reflect these changes.

To find out more about compliance for medical devices in the EU and on other markets, please do not hesitate to contact the Product Compliance Institute.