The Euro­pean Com­mis­sion has offi­cial­ly rec­om­mend­ed to post­pone Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) for one year. All eyes are on the EU insti­tu­tions if the pro­pos­al will be adopt­ed in time before May 26, 2020, the date of full appli­ca­tion of the MDR. As for Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR), there are no plans for a delay.

Despite these devel­op­ments, the Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished a num­ber of updat­ed and new guid­ance documents.

Updates:

MDCG 2018-1, which pro­vides guid­ance about the Basic UDI-DI and changes to the UDI-DI under the MDR and IVDR has been updat­ed and is avail­able in its third version.

MDCG 2019-8, which pro­vides guid­ance on implant cards under the MDR has been updat­ed and is avail­able in its sec­ond revision.

New guid­ance documents:

MDCG 2020-1 pro­vides guid­ance on clin­i­cal eval­u­a­tions (MDR) and per­for­mance eval­u­a­tions (IVDR) for Med­ical Device Soft­ware (MDSW). The doc­u­ment is intend­ed to clar­i­fy the lev­el of clin­i­cal evi­dence man­u­fac­tur­ers are required to include in their eval­u­a­tion doc­u­ments. It is high­ly rec­om­mend­ed for man­u­fac­tur­ers of MDSW as clin­i­cal eval­u­a­tions or per­for­mance eval­u­a­tions respec­tive­ly are an inte­gral part of the tech­ni­cal doc­u­men­ta­tion under the MDR and IVDR.

MDCG 2020-2 is essen­tial­ly impor­tant for class I med­ical device man­u­fac­tur­ers who may and want to make use of the extend­ed tran­si­tion peri­od until May 25, 2024. This con­cerns devices that would need a Noti­fied Body under the MDR for the first time due to new clas­si­fi­ca­tion rules, i.e. reusable sur­gi­cal instru­ments, cer­tain soft­ware prod­ucts, sub­stance based devices, inhalers, etc.

These prod­ucts may con­tin­ue to be placed on the mar­ket under the MDD until May 25, 2024 if cer­tain con­di­tions are met. Among oth­ers, no sig­nif­i­cant changes to the design or intend­ed pur­pose of the device may be imple­ment­ed after the MDR data of appli­ca­tion. In addi­tion, a Dec­la­ra­tion of Con­for­mi­ty in accor­dance with the Med­ical Devices Direc­tive (MDD) must be drawn up before the MDR date of appli­ca­tion. If the applic­a­ble MDR date of appli­ca­tion will be May 26, 2020 or May 26, 2021 remains to be seen and depends on the out­come of the post­pone­ment pro­pos­al men­tioned above. The guid­ance doc­u­ment spec­i­fies the details that should be includ­ed in the Dec­la­ra­tion of Con­for­mi­ty. Man­u­fac­tur­ers are high­ly rec­om­mend­ed to care­ful­ly review the doc­u­ment and imple­ment the requirements.

MDCG 2020-3 is an impor­tant guid­ance doc­u­ment for man­u­fac­tur­ers who want to con­tin­ue plac­ing prod­ucts on the mar­ket under an MDD/ AIMDD cer­tifi­cate beyond the MDR date of appli­ca­tion and also for class I device man­u­fac­tur­ers mak­ing use of the extend­ed tran­si­tion period.

The guid­ance pro­vides addi­tion­al details what sce­nar­ios would include sig­nif­i­cant changes and which changes would not be con­sid­ered sig­nif­i­cant in this context.

One of the con­di­tions to fol­low this route is that no sig­nif­i­cant changes to the design or intend­ed pur­pose of the device may be imple­ment­ed. The guid­ance pro­vides addi­tion­al details what sce­nar­ios would include sig­nif­i­cant changes and which changes would not be con­sid­ered sig­nif­i­cant in this context.

The doc­u­ment makes clear that in case of doubt, the Noti­fied Body should be con­sult­ed. Admin­is­tra­tive changes are gen­er­al­ly not con­sid­ered sig­nif­i­cant because they do not alter the design or intend­ed pur­pose. MDCG 2020-3 offers use­ful flow­charts for the deci­sion mak­ing process.

Class I device man­u­fac­tur­ers who would need a Noti­fied Body for the first time due to the MDR’s amend­ed clas­si­fi­ca­tion rules, are request­ed to doc­u­ment changes and pre­pare a jus­ti­fi­ca­tion why changes are not sig­nif­i­cant in this con­text. These must be pro­vid­ed upon request.

Sources: MDCG guid­ance documents

To com­ple­ment this arti­cle we rec­om­mend the fol­low­ing sources