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How long will it take to val­i­date my product?

The time between pur­chase order and sub­mis­sion of the study report is usu­al­ly 6 – 12 months depend­ing on the com­plex­i­ty of the clin­i­cal per­for­mance study. Lead times for val­i­da­tion depend on the intend­ed pur­pose of the prod­uct. If suit­able sam­ple donors are abun­dant, the sam­pling process is uncom­pli­cat­ed, and the required sam­ple size is low, lead time will be short. In the case of a high num­ber of donors with rare dis­eases are need­ed for a com­pli­cat­ed sam­pling pro­ce­dure, lead time will be long.

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How much will it cost to val­i­date my product?

Cost require­ments of a clin­i­cal per­for­mance study are usu­al­ly 80,000 € – 350,000 €. The price is very much depen­dent on the intend­ed pur­pose of the prod­uct. Fac­tors that dri­ve costs are, among oth­ers, required sam­ple size, num­ber of sam­ple types, com­plex­i­ty of analy­sis (PCR is more expen­sive than a lat­er­al flow test), num­ber of dif­fer­ent analy­ses, and devi­a­tion from diag­nos­tic routine.

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Do you also offer prod­uct devel­op­ment ser­vices and ana­lyt­i­cal per­for­mance studies?

Our own ser­vices focus on clin­i­cal val­i­da­tions. To be able to pro­vide a full-range ser­vice for the whole val­ue-chain of IVD prod­ucts, we col­lab­o­rate with part­ner com­pa­nies whose exper­tise fills our gaps. IVD prod­uct devel­op­ment and ana­lyt­i­cal per­for­mance stud­ies are car­ried out by our part­ners from Future Diag­nos­tics B.V. If required, we would be glad to estab­lish a contact.

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Is the CE-labelling done by ICS?

No. ICS only func­tions as a Con­tract Research Orga­ni­za­tion (CRO) for the plan­ning, con­duct, and eval­u­a­tion of the clin­i­cal per­for­mance study. CE-cer­ti­­fi­­ca­­tion can only be car­ried out by accred­it­ed noti­fied bod­ies. Cur­rent­ly (Sep­tem­ber 2023), there are twelve noti­fied bod­ies des­ig­nat­ed under IVDR 2017/746: DEKRA Cer­ti­fi­ca­tion GmbH (Ger­many), DEKRA Cer­ti­fi­ca­tion B.V. (Nether­lands), TÜV SÜD Prod­uct Ser­vice GmbH (Ger­many), TÜV Rhein­land LGA Prod­ucts GmbH (Ger­many), BSI Group The Nether­lands B.V. (Nether­lands), GMED SAS (France), Nation­al Stan­dards Author­i­ty of Ire­land (Ire­land), MDC Med­ical Device Cer­ti­fi­ca­tion GmbH (Ger­many), 3EC Inter­na­tion­al a.s. (Slo­va­kia), QMD Ser­vices GmbH (Aus­tria), Eurofins Elec­tric & Elec­tron­ics Fin­land Oy (Fin­land), and Ser­tio Oy (Fin­land). Please con­sid­er the indi­vid­ual scope of IVD-prod­ucts that the indi­vid­ual noti­fied bod­ies are accred­it­ed for.

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Can you skip eth­i­cal clear­ance to accel­er­ate the val­i­da­tion process?

The involve­ment of an ethics com­mit­tee before the start of a study can only be skipped in very rare cas­es. This depends on the spec­i­fi­ca­tions of the prod­uct which is to be val­i­dat­ed. Even in those cas­es, we strong­ly rec­om­mend the involve­ment of an ethics committee.

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Will a noti­fied body accept the clin­i­cal study report?

Yes, our study plans and study reports are designed to ful­fil all reg­u­la­to­ry requirements.

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Can ICS con­tact the noti­fied body to accel­er­ate the con­for­mi­ty assess­ment process?

No. Com­mu­ni­ca­tion with the noti­fied body is done by the man­u­fac­tur­er or – in case of non-EU man­u­fac­tur­ers – by the autho­rised rep­re­sen­ta­tive. If you need an autho­rised rep­re­sen­ta­tive, we rec­om­mend Qarad BV. If required, we would be glad to estab­lish a contact.

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I need very spe­cif­ic pre-ana­lyt­i­cal con­di­tions; can this be accommodated?

Yes. Sam­ples for clin­i­cal per­for­mance stud­ies must fit pre­cise­ly to the intend­ed pur­pose of the val­i­dat­ed prod­uct. We pro­cure all sam­ples in a project-spe­­cif­ic man­ner and accord­ing to the study requirements.

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Is your lab­o­ra­to­ry certified?

Our study site and lab­o­ra­to­ry are not cer­ti­fied accord­ing to any offi­cial stan­dard. In all cas­es where such stan­dards are need­ed (e.g., because the intend­ed pur­pose of the val­i­dat­ed prod­uct requires it), we col­lab­o­rate with exter­nal study sites that are fit for the pur­pose. This is a stan­dard pro­ce­dure; most clin­i­cal per­for­mance stud­ies are con­duct­ed in exter­nal study sites due to the dif­fer­ent indi­vid­ual require­ments of IVD products.

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Where do you source the samples?

This depends on the required sam­ple spec­i­fi­ca­tions. Sam­ples that can­not be col­lect­ed in our own study site are col­lect­ed in col­lab­o­rat­ing study sites. ICS prof­its from a dense net­work of col­lab­o­ra­tions to clin­ics, test cen­tres, and physi­cians’ prac­tices from all med­ical fields.