There cer­tain­ly is a back­log in guid­ance espe­cial­ly relat­ed to the IVDR. In May, how­ev­er, the Med­ical Device Coor­di­na­tion Group (MDCG) has issued a num­ber of doc­u­ments that may help man­u­fac­tur­ers and oth­er eco­nom­ic oper­a­tors in the IVDR implementation:

MDCG 2022-7 is a Q&A doc­u­ment around the top­ic of Unique Device Iden­ti­fi­ca­tion (UDI). Ques­tions are struc­tured in dif­fer­ent cat­e­gories, i.e. UDI-DI, Basic UDI-DI, UDI Labelling, Sys­tems and Pro­ce­dure Packs, Retail and Pro­mo­tion, Kits and Eudamed. We have received spe­cif­ic ques­tions regard­ing UDI in the past months. Please review the doc­u­ment to see if unad­dressed issues are answered with the guidance.

MDCG 2022-8 pro­vides infor­ma­tion on which IVDR require­ments are applic­a­ble for lega­cy and old devices, i.e. those prod­ucts that have been or will con­tin­ue to be placed on the mar­ket under the IVDD. The guid­ance is based on MDCG 2021-25, which has been set up for med­ical devices. It pro­vides valu­able infor­ma­tion includ­ing an annex table as to how eco­nom­ic oper­a­tors should under­stand the tran­si­tion­al pro­vi­sions and what spe­cif­ic pro­vi­sions must be implemented.

MDCG 2022-9 includes advice and a tem­plate for IVDR man­u­fac­tur­ers to set up a sum­ma­ry of safe­ty and per­for­mance. This is a require­ment for class C and D devices.

Last­ly, MDCG 2022-10 is also intend­ed for man­u­fac­tur­ers of IVD med­ical devices under the IVDR. It is a Q&A doc­u­ment that address­es spe­cif­ic issues relat­ed to assays used in clin­i­cal tri­als. The lat­ter may range from CE-marked IVDs to tri­al- or drug-spe­cif­ic assays that are not always meant to be devel­oped as IVDs – reg­u­la­to­ry ques­tions are not always clear­ly addressed for these cases.

Should you be inter­est­ed in receiv­ing one or sev­er­al of the doc­u­ments, please let us know and we will be hap­py to provide.

Source: MDCG

For fur­ther infor­ma­tion on this sub­ject please browse our web­site by key­word MDCG.