The MDR brings many chal­lenges for med­ical device man­u­fac­tur­ers. Cer­tain­ly, an area that requires increased atten­tion and care­ful plan­ning is labeling.

Sec­tion 23 of annex I of the MDR defines the Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR) for labels and instruc­tions for use. Depend­ing on the intend­ed use of a device, numer­ous changes may need to be imple­ment­ed under the MDR – com­pared to the MDD.

Below is a non-exhaus­tive list of ele­ments that should be considered

Source: MDR

In case you need to know more on label­ing changes

For relat­ed infor­ma­tion about label­ing changes please also check our top­ics as linked below. If you have any spe­cif­ic ques­tions or require assis­tance for com­pli­ance of your labels and IFU, please don’t hes­i­tate to get in touch with us. 

Vis­it our Sup­port­ive Infor­ma­tion Sec­tion regard­ing MDR / IVDR.
Or get in con­tact with our team.