EU: Medical devices – electronic instructions for use

 

The EU Commission has published a delegated act allowing instructions for use in electronic format for all medical devices intended for exclusive use by healthcare professionals.

Commission Implementing Regulation (EU) 2021/2226 currently applies only to specific medical devices and their accessories. However, a survey conducted by the Commission between 1 August and 10 October 2024 on the replacement of paper-based instructions for use with electronic ones revealed a clear preference among healthcare professionals for receiving instructions in electronic format. Providing instructions electronically enables the healthcare sector to deliver more efficient and timely solutions.

In light of these findings, the scope of Implementing Regulation (EU) 2021/2226 should be broadened to include all medical devices and their accessories intended for professional users, as defined under Regulation (EU) 2017/745. Once registration in the European database on medical devices (Eudamed) becomes mandatory, manufacturers will be required to submit to the UDI database the Uniform Resource Locator (URL) where the electronic instructions for use can be consistently accessed.

For devices subject to the transitional provisions of Article 120 of Regulation (EU) 2017/745, the now-repealed Commission Regulation (EU) No 207/2012 should remain applicable until the end of the transitional period specified in Article 120(3a)(b) of Regulation (EU) 2017/745.

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

To find out more about the product compliance for medical devices, do not hesitate to contact the Product Compliance Institute.