The Med­ical Device Coor­di­na­tion Group (MDCG) has recent­ly issued guid­ance MDCG 2022-6, Guid­ance on sig­nif­i­cant changes regard­ing the tran­si­tion­al pro­vi­sion under Arti­cle 110(3) of the IVDR.

Arti­cle 110(3) of the IVDR lays out the tran­si­tion­al pro­vi­sions for lega­cy devices, i.e. IVD med­ical devices that may con­tin­ue to be placed on the mar­ket under the IVDD beyond May 25, 2022. One of the con­di­tions to make use of the tran­si­tion­al peri­od is that no sig­nif­i­cant changes to the device’s intend­ed pur­pose or design must be imple­ment­ed. In case of a sig­nif­i­cant change, the device must demon­strate full com­pli­ance to the IVDR require­ments immediately.

MDCG 2020-6 pro­vides valu­able exam­ples and flow charts man­u­fac­tur­ers, noti­fied bod­ies and com­pe­tent author­i­ties may use to deter­mine if a change is sig­nif­i­cant or non-significant. 

Among oth­ers, the guid­ance says that the addi­tion of spec­i­men types rep­re­sents a sig­nif­i­cant change of the intend­ed purpose.

Among oth­ers, the guid­ance says that the addi­tion of spec­i­men types rep­re­sents a sig­nif­i­cant change of the intend­ed pur­pose. MDCG 2022-6 also men­tions that reduced sen­si­tiv­i­ty or speci­fici­ty val­ues that have to be includ­ed in the IFU due to PMS activ­i­ties rep­re­sent a sig­nif­i­cant change because this adverse­ly affects the device per­for­mance. The lat­ter can be espe­cial­ly crit­i­cal for man­u­fac­tur­ers of IVD tests relat­ed to the SARS-CoV-2 virus who are still work­ing on com­pli­ance with guid­ance doc­u­ments like MDCG 2021-21 and thus have to pro­vide addi­tion­al per­for­mance data after May 25, 2022.

As an over­all prin­ci­ple, changes must be doc­u­ment­ed and held avail­able for com­pe­tent author­i­ties and noti­fied bod­ies if requested.

We would also like to draw your atten­tion to doc­u­ment man­age­ment and release pro­ce­dures in that regard. Essen­tial doc­u­ments like the dec­la­ra­tion of con­for­mi­ty should not be changed after May 25, 2022 unless this is required by the IVDR. If a change is imple­ment­ed after May 25, 2022, this should be backed by a reg­u­la­to­ry ratio­nale in accor­dance with MDCG 2022-6.

We strong­ly sug­gest to care­ful­ly ready the guid­ance doc­u­ment and imple­ment the cor­re­spond­ing pro­ce­dures. Should you wish to receive the guid­ance doc­u­ment, please don’t hes­i­tate to get in touch.

Source: MDCG