IVD per­for­mance eva­lua­ti­on test­ing with “resi­du­al samples”?

Need for “resi­du­al samples”

Manu­fac­tu­r­ers of in vitro dia­gno­stic (“IVD”) devices rely on using sam­ple mate­ri­al of human ori­gin as part of pro­duct deve­lo­p­ment and to per­form per­for­mance eva­lua­ti­on test­ing. Cor­re­spon­ding mate­ri­al is gene­ral­ly available: so-called “resi­du­al samples” regu­lar­ly accu­mu­la­te in medi­cal dia­gno­stic labo­ra­to­ries. At pre­sent, howe­ver, this mate­ri­al is gene­ral­ly dis­po­sed of and not pas­sed on to manu­fac­tu­r­ers for IVDs. The reason for this is the con­cern of the labo­ra­to­ries that the pro­vi­si­on of such resi­du­al samples could vio­la­te the rules of the GDPR or medi­cal device regulations.

The term “resi­du­al sample”

Uncer­tain­ty regar­ding the hand­ling of resi­du­al samples exists sim­ply due to the fact that the term is not men­tio­ned in the regu­la­ti­ons curr­ent­ly still appli­ca­ble to IVDs, the IVD Direc­ti­ve (PDF) and the Medi­cal Devices Direc­ti­ve (only in Ger­man). It was not until the IVD Regu­la­ti­on and the Medi­cal Devices Imple­men­ta­ti­on Act (MPDG) came into force that the term was defi­ned and made an issue. In prin­ci­ple, the­re are pos­si­ble uses for resi­du­al samples. This can be pos­si­ble under dif­fe­rent con­di­ti­ons in each spe­ci­fic case. In addi­ti­on, noti­fi­ca­ti­on obli­ga­ti­ons and pati­ents’ rights must be observed.

Recom­men­da­ti­on for action

IVD manu­fac­tu­r­ers should con­sider the fol­lo­wing pri­or to using sam­ple mate­ri­al in the con­text of pro­duct deve­lo­p­ment or per­for­mance evaluation:

1.    Does the mate­ri­al basi­cal­ly con­sti­tu­te usable “resi­du­al samples” in the terms of the regu­la­ti­ons?
2.    Is pati­ent con­sent requi­red for use?
3.    Are the regu­la­to­ry requi­re­ments for use met?

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