The Euro­pean Commission’s Direc­torate-Gen­er­al for Health and Food Safe­ty (DG SANTE) has released a con­sol­i­dat­ed overview link­ing to the pub­lished fee lists of noti­fied bod­ies (NBs) des­ig­nat­ed under the Med­ical Devices Reg­u­la­tion (MDR) and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR).

The doc­u­ment gath­ers, in two tables, direct hyper­links to fee sched­ules pub­lished on indi­vid­ual NB websites—Table 1 cov­er­ing MDR ser­vices and Table 2 cov­er­ing IVDR services—spanning bod­ies across Ger­many, Italy, France, Ire­land, the Nordics, Cen­tral Europe and beyond.

Its pur­pose is trans­paren­cy. Both Reg­u­la­tions require noti­fied bod­ies to make their stan­dard fees pub­licly avail­able, and this overview cen­tralis­es that scat­tered infor­ma­tion in one place. For man­u­fac­tur­ers, it offers a prac­ti­cal start­ing point for bench­mark­ing con­for­mi­ty-assess­ment costs and com­par­ing NBs when plan­ning cer­ti­fi­ca­tion or sup­pli­er selection.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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