On Novem­ber 27, the Euro­pean Com­mis­sion pub­lished anoth­er report on the expert pan­el review of an in vit­ro diag­nos­tic device in the con­text of the Per­for­mance Eval­u­a­tion Con­sul­ta­tion Pro­ce­dure (PECP). 

In this case, a MERS-CoV test was reviewed. Among oth­ers, the expert pan­el con­clud­ed that “[…] addi­tion­al data spe­cif­ic to MERS are nec­es­sary. Rec­om­men­da­tions include con­duct­ing in-depth ana­lyt­i­cal stud­ies, in sil­i­co analy­ses, and clin­i­cal val­i­da­tion through com­par­a­tive stud­ies with CE-marked MERS assays to enhance con­fi­dence in MERS detec­tion capa­bil­i­ties.”

Expert pan­el opin­ions are an impor­tant indi­ca­tor for expec­ta­tions of noti­fied bod­ies and com­pe­tent author­i­ties with regards to the per­for­mance eval­u­a­tion of spe­cif­ic IVD med­ical devices.

The review can be accessed here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website