The Euro­pean Asso­ci­a­tion of Med­ical devices Noti­fied Bod­ies, TEAM NB, pub­lished revi­sion 2 of its “Best Prac­tice Guid­ance for the Sub­mis­sion of Tech­ni­cal Doc­u­men­ta­tion under Annex II and III of In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746”.

As per the scope of the doc­u­ment, “[t]his best prac­tice guid­ance doc­u­ment has been devel­oped by mem­bers of Team NB who have reviewed the best prac­tice guid­ance doc­u­ments sub­mit­ted by indi­vid­ual Team NB noti­fied body mem­bers, with the pur­pose to devel­op a uni­fied approach on the expec­ta­tions of tech­ni­cal doc­u­men­ta­tion sub­mis­sions from man­u­fac­tur­ers.”

It is thus a high­ly rec­om­mend­able doc­u­ment for all man­u­fac­tur­ers of IVD med­ical devices who need to go through a noti­fied body assess­ment under the IVD med­ical devices reg­u­la­tion (IVDR).

We would also like to point out that the doc­u­ment is very use­ful for man­u­fac­tur­ers of class A devices. Even though class A devices do not need to go through noti­fied body cer­ti­fi­ca­tion, expec­ta­tions of noti­fied bod­ies and com­pe­tent author­i­ties who are in charge of mar­ket sur­veil­lance activ­i­ties, are gen­er­al­ly in con­cert. IVDR tech­ni­cal doc­u­men­ta­tion require­ments apply for all risk classes. 

Source: TEAM NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse our web­site by tag “Guid­ance Documents”