New MDR and IVDR check­lists for PMS and Dec­la­ra­tion of Conformity

Dur­ing the past years, mdi Europa has pro­vid­ed a num­ber of tem­plates and check­lists that may be use­ful for the tran­si­tion of the Med­ical Devices Reg­u­la­tion and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (2017/745, MDR and 2017/746, IVDR).

Recent­ly, mdi Europa has set up new check­lists on the fol­low­ing topics:

• Dec­la­ra­tion of Conformity
• Post Mar­ket Sur­veil­lance (PMS) Plan 
• Peri­od­ic Safe­ty Update Report (PSUR)

Pre­lim­i­nary ver­sions may be reviewed in our Sup­port­ive Infor­ma­tion sec­tion (use link below) and are avail­able for free for our clients. Should you be inter­est­ed in join­ing mdi Europa and receiv­ing a copy, please let us know and we will be hap­py to ini­ti­ate a cooperation.

Sup­port­ive Infor­ma­tion Sec­tion MDR/IVDR