Man­u­fac­tur­ers of med­ical devices are eager­ly wait­ing for more guid­ance on the imple­men­ta­tion of the MDR. MDCG has now issued a use­ful guid­ance on the Sum­ma­ry of Safe­ty and Clin­i­cal Per­for­mance (SSCP) and on the han­dling of MDD cer­tifi­cates for lega­cy devices.

The Med­ical Device Coor­di­na­tion Group (MDCG) issued a new guid­ance doc­u­ment on cer­tifi­cates that have been issued under the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD) and the Med­ical Devices Direc­tive 93/42/EEC (MDD).

Arti­cle 120 of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) gen­er­al­ly says that prod­ucts that have been man­u­fac­tured in accor­dance with a valid MDD cer­tifi­cate beyond May 2020, may still be placed on the mar­ket until the cor­re­spond­ing cer­tifi­cate expires. How­ev­er, the issu­ing Noti­fied Body still remains respon­si­ble for the sur­veil­lance activ­i­ties as a precondition.

The MDCG doc­u­ment now clar­i­fies that the con­tract between the man­u­fac­tur­er and the Noti­fied Body must pro­vide for the sur­veil­lance respon­si­bil­i­ties for the cer­tifi­cate (diesen Satz als Pul­lquote). Fur­ther­more, the doc­u­ment says that that “Author­i­ties respon­si­ble for noti­fied bod­ies have the right to and do mon­i­tor those noti­fied body’s activ­i­ties to the extent appro­pri­ate and necessary.”

Fur­ther­more, MDCG pub­lished a guid­ance doc­u­ment on the SSCP. Accord­ing to arti­cle 32 of the MDR, man­u­fac­tur­ers of implanta­bles and class III devices must set up the SSCP and pro­vide it to the Noti­fied Body. The Noti­fied Body will then upload the doc­u­ment to EUDAMED.

The guid­ance spec­i­fies among oth­ers, which con­tents should be includ­ed and pro­vides details about the val­i­da­tion pro­ce­dure. It also reflects a sam­ple template.

Should you have any spe­cif­ic ques­tions or require the full doc­u­ment for your ref­er­ence, please don’t hes­i­tate to get in touch.

Sources: MDCG guid­ance doc­u­ments, MDR

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