EU Medical Device Regulation to Allow Electronic Instructions for Use

The European Commission said medical devices may be marketed with electronic instructions for use (IFUs) under the EU’s Medical Device Regulation.

Devicemakers will need to indicate on the product packaging that the instructions for use are supplied in electronic rather than paper form and must provide information on how to access the IFUs in a commonly available format.

Manufacturers will also need to develop a contingency plan for users who may not have internet access.