The Med­ical Device Coor­di­na­tion Group (MDCG) has issued new guid­ance doc­u­ments under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR):

  1. MDCG 2021-08 lays out appli­ca­tion mech­a­nisms includ­ing appli­ca­tion forms for clin­i­cal inves­ti­ga­tions. These are to be used in the absence of EUDAMED as a cen­tral reg­is­tra­tion plat­form for clin­i­cal stud­ies. The includ­ed forms are aligned as far as pos­si­ble with the planned EUDAMED data fields.
  2. MDCG 2021-09 spec­i­fies UDI require­ments for man­u­fac­tur­ers of con­tact lens­es, spec­ta­cle frames, spec­ta­cle lens­es and ready read­ers. Among oth­ers, man­u­fac­tur­ers are remind­ed that they must set up the UDI sys­tem as per MDR require­ments. Fur­ther­more, man­u­fac­tur­ers of the afore­men­tioned prod­ucts should not use the vol­un­tary UDI/ device reg­is­tra­tion in EUDAMED until fur­ther notice. 
  3. MDCG 2021-11 on implant cards is com­ple­men­tary to MDCG 2019-8. The guid­ance pro­vides a non-exhaus­tive list of implantable med­ical device types to aid man­u­fac­tur­ers allo­cate the appro­pri­ate term allow­ing the iden­ti­fi­ca­tion of the device on the implant card.
  4. MDCG 2021-12 can be cross-ref­er­enced to our arti­cle from our May newslet­ter on the EMDN web­site. The guid­ance pro­vides FAQ and answers on the new Euro­pean nomen­cla­ture sys­tem. 

Should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch. We are also hap­py to pro­vide you with the cor­re­spond­ing guid­ance documents.

Source: Euro­pean Commission

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing con­tent on our website