The Euro­pean Commission’s Med­ical Devices Coor­di­na­tion Group (MDCG) recent­ly pub­lished two guid­ance doc­u­ments on time­lines for device reg­is­tra­tion and on reg­is­tra­tion expec­ta­tions for man­u­fac­tur­ers of lega­cy devices. Lega­cy devices in this con­text refer to those devices that will be placed on the mar­ket with a direc­tive cer­tifi­cate beyond May 26, 2020 (MDR date of appli­ca­tion) or May 26, 2022 (IVDR date of appli­ca­tion) respectively. 

The inten­tion of these guid­ance doc­u­ments is to close gaps in the inter­pre­ta­tion of the afore­men­tioned time­lines and reg­is­tra­tion requirements.

Time­lines

Arti­cle 29 of the MDR pro­vides for the reg­is­tra­tion of devices in EUDAMED as of May 26, 2020 with the data ele­ments list­ed in annex VI, part A, sec­tion 2 and annex VI, part B of the MDR. How­ev­er, the present guid­ance takes the posi­tion that arti­cle 123(3)(e) defines a tran­si­tion peri­od for the pro­vi­sion of these data ele­ments of 18 months, or, if EUDAMED should not be ful­ly func­tion­al on time, of 24 months.

The guid­ance doc­u­ment also makes clear that man­u­fac­tur­ers nonethe­less have to assign the Basic UDI-DI and UDI-DI as of May 26, 2020.

The guid­ance doc­u­ment also makes clear that man­u­fac­tur­ers nonethe­less have to assign the Basic UDI-DI and UDI-DI as of May 26, 2020. Also, the full reg­is­tra­tion of devices may become nec­es­sary before the end of the above-men­tioned tran­si­tion peri­od if a rel­e­vant seri­ous adverse event must be reg­is­tered in EUDAMED.

Lega­cy Devices

As already men­tioned in ear­li­er dis­cus­sions, man­u­fac­tur­ers of lega­cy devices must in accor­dance with arti­cles 120(3) of the MDR ful­fill the MDR require­ments on post-mar­ket sur­veil­lance, mar­ket sur­veil­lance, vig­i­lance, reg­is­tra­tion of eco­nom­ic oper­a­tors as of May 26, 2020. Although man­u­fac­tur­ers of lega­cy devices do not have to ful­fill the nor­mal MDR UDI oblig­a­tions they are oblig­ed to ful­fill reg­is­tra­tion require­ments, which in turn requires the imple­men­ta­tion of the UDI sys­tem. This is where the explana­to­ry gap persisted. 

With the present guid­ance doc­u­ment, the bot­tom line is that the MDCG expects man­u­fac­tur­ers to reg­is­ter their devices into EUDAMED 18 or 24 months respec­tive­ly after the date of appli­ca­tion as stat­ed above. In addi­tion, the reg­is­tra­tion of lega­cy devices may become nec­es­sary ear­li­er if a rel­e­vant seri­ous adverse event must be reg­is­tered in EUDAMED.

For this pur­pose, EUDAMED will allow for the reg­is­tra­tion of lega­cy devices also if no Basic UDI-DI and UDI-DI has been assigned yet. Accord­ing­ly, there will be a EUDAMED-DI instead of the Basic UDI-DI and a EUDAMED-ID instead of the UDI-DI. The EUDAMED-DI may entire­ly be gen­er­at­ed by EUDAMED or par­tial­ly assigned by the man­u­fac­tur­er. The EUDAMED-ID will always be gen­er­at­ed by EUDAMED.

Fur­ther details can be retrieved from the cor­re­spond­ing guid­ance doc­u­ments. Should you wish to review the full ver­sions, please let us know and we will be hap­py to pro­vide. The afore­men­tioned con­sid­er­a­tions apply mutatis mutan­dis for the IVDR, i.e. while mak­ing the nec­es­sary alter­ations to account for the IVD Reg­u­la­tion specifics.

Please note also that the MDCG doc­u­ments are only guid­ance. They are rep­re­sent­ing the cur­rent posi­tion and opin­ion of the Euro­pean Com­mis­sion, but they are not legal­ly binding. 

Sources: MDCG guid­ance doc­u­ments on devices reg­is­tra­tion and reg­is­tra­tion of lega­cy devices

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