The Med­ical Device Coor­di­na­tion Group (MDCG) has recent­ly pub­lished a use­ful guid­ance on the Implant Card (IC) accord­ing to arti­cle 18 of the MDR. 

It makes sense to review the doc­u­ment in detail, so if this require­ment applies to one of your prod­ucts, please let us know and we will send the com­plete ver­sion to you. Below, we con­densed some of the main aspects for a first overview. The guid­ance doc­u­ment sug­gests to include the fol­low­ing details on the IC:

  1. Device name; 
  2. Device type; 
  3. Ser­i­al num­ber or, where applic­a­ble, lot or batch number; 
  4. Unique Device Iden­ti­fi­ca­tion (UDI); the UDI as AIDC4 for­mat and the UDI-DI as HRI5 
  5. Name and address of the man­u­fac­tur­er of the med­ical device; 
  6. Web­site of the man­u­fac­tur­er of the med­ical device. 

The guid­ance also sug­gests the usage of a sup­ple­men­tary leaflet to include the expla­na­tion of sym­bols, the instruc­tions how to com­plete the IC and also to adhere to the lan­guage require­ments. Final­ly, there are use­ful insights about sym­bols to be used and design exam­ples of ICs.

Source: MDCG guid­ance on implant cards

We pro­vide addi­tion­al infor­ma­tion and doc­u­ments on this subject

Guid­ance Doc­u­ments in our Com­plete Down­load Sec­tion regard­ing MDR
Guid­ance Doc­u­ments in our Com­plete Down­load Sec­tion regard­ing IVDR

If you require fur­ther infor­ma­tion on this top­ic, please don’t hes­i­tate to get in touch with our team.