COCIR, together with other European Trade Associations, has developed an industry guidance on Electronic Instructions for Use (eIFU), which provide ability to have more ergonomic interfaces and possibilities to use various multimedia platforms to host tutorials and presentations.

According to the Commission Regulation (EU) No. 207/2012 of 09 March 2012

“Manufacturers shall clearly indicate that the instructions for use of the device are supplied in electronic form instead of in paper form.”  That information shall be provided on the packaging for each unit or, where appropriate, on the sales packaging. In the case of fixed installed medical devices, that information shall also be provided on the device itself.

In order to help manufacturers to comply with the Regulation, the Medical Device Industry - represented here by COCIR, EUCOMED, EUROM VI, EUROMCONTACT and FIDE- has released a Guidance on device, unit pack or sales packing information for the supply of eIFU.

One of the key recommendations of the Guidance is to use a symbol already known to end users, referring to IFU and to add an indicator that would refer to the electronic format.  Such a harmonized industry approach should help users and customers to quickly adapt to new labelling format and ensure better access to information.

 
This Joint Industry Guidance has also been communicated for information to the European Commission and the Medical Devices Expert Group members (composed of representatives of EU Member States and other key stakeholders).