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.