Ethical and regulatory clearance – Clinical validation takes longer than you think!

The new IVDR tran­si­tion­al peri­ods that have been pub­lished in Jan­u­ary 2022 took some pres­sure from all of us who still need to re-val­i­date a bunch of IVD-prod­ucts for IVDR-compliance.
Nonethe­less, there is no time to lose! Clin­i­cal per­for­mance stud­ies take longer than you might expect.
Did you know that by law a Ger­man ethics com­mit­tee has 30 days to give you their opin­ion on your study plan (§36 Medizinprodukterecht-Durchführungsgesetz)?
Fur­ther­more, most clin­i­cal per­for­mance stud­ies must be approved by gov­ern­men­tal author­i­ties. By law, they have 45 days to send you their final statement.
Addi­tion­al delays, for instance when spe­cialised infor­ma­tion is required by ethics com­mit­tee or author­i­ties, or when exter­nal experts are to be con­sult­ed, are not con­sid­ered here.
This means that even in the case of no unnec­es­sary delays there is a poten­tial lead time of 2,5 months only to receive the approval to start with the clin­i­cal per­for­mance study.
Because of this and oth­er fac­tors, often­times there is sim­ply not enough time to meet our client’s dead­line for sub­mis­sion of the tech­ni­cal doc­u­men­ta­tion to the noti­fied body.
Long sto­ry short: Don’t hes­i­tate to con­tact us for the clin­i­cal val­i­da­tion of your prod­ucts. Time is run­ning short already! Include a min­i­mum of 9 to 12 months for the clin­i­cal per­for­mance study in your planning.