There are numer­ous chal­lenges relat­ed to Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) respectively.

Among those, the avail­abil­i­ty of noti­fied bod­ies was and is one of the core issues. In this con­text, it is with­in the inter­est of noti­fied bod­ies and man­u­fac­tur­ers that con­for­mi­ty assess­ment pro­ce­dures move for­ward as smooth as possible.

To facil­i­tate this process and to help man­u­fac­tur­ers prepar­ing appro­pri­ate sub­mis­sions, Team-NB recent­ly pub­lished and updat­ed posi­tion papers where rec­om­men­da­tions are pro­vid­ed what aspects should be regard­ed in tech­ni­cal doc­u­men­ta­tion submissions.

Team-NB is the Euro­pean asso­ci­a­tion for med­ical device noti­fied bod­ies. Their guid­ance rep­re­sents the per­spec­tive of mem­ber orga­ni­za­tions and is an impor­tant indi­ca­tor for man­u­fac­tur­ers regard­ing MDR and IVDR relat­ed expectations.

Should you wish to learn more and/ or have mdi Europa send­ing you the afore­men­tioned posi­tion papers, please let us know.

Source: Team-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website