EU MDR 23.4 IFU (Device Code?)

[Amy Elizabeth]

Hello All,

Can anyone confirm if device codes are required on IFUs? We have the device tech file group/product family. But if we were to list each code this would be quite large. I cant see anything specifically obvious in 24.3 but wondered if anyone knew of any more hidden suggestions that it does.

 

[Nichole F]

I've never heard of a device code being included in the IFU aside from a product or REF number. What device code are you thinking might need to be included? EMDN? MDA/MDN?
The EMDN needs to be included in the technical documentation but the EMDN/MDA/MDN is likely to mean anything to anyone other than your notified body.

 

[Pavol M]

There are no requirements for codes in the instructions for use in the Medical Device Regulation (MDR). The information in the instructions for use should be the output of the technical documentation, clinical evaluation and risk management.

If there are risks associated with some of the codes, you may consider adding codes to the instructions for use.

 

[Amy Elizabeth]

Sorry I meant Product codes. Thank you @Pavol M