Inter­est group for noti­fied bod­ies Team NB has updat­ed its Code of Con­duct (CoC) under Reg­u­la­tions (EU) 2017/745 on med­ical devices (MDR) and (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). The new doc­u­ment was issued on Sep­tem­ber 16 under ver­sion 5.0.

The updat­ed CoC has been revised to reflect the cur­rent applic­a­ble leg­is­la­tion and guid­ance doc­u­ments. Changes com­prise, but are not lim­it­ed to:

– Esti­ma­tion of time need­ed for tech­ni­cal doc­u­men­ta­tion review
– Detailed expla­na­tion of re-cer­ti­fi­ca­tion require­ments
– Clar­i­fied require­ments for unan­nounced audit
– Required of time need­ed for cor­rec­tive and pre­ven­tive action (CAPA)

Should you wish to take a clos­er look at the doc­u­ment, you may access it here.

Source: Team NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website