Noti­fied body asso­ci­a­tion Team-NB has pub­lished a posi­tion paper estab­lish­ing har­monised expec­ta­tions for “Demon­stra­tion of Safe­ty and Per­for­mance for Com­bi­na­to­r­i­al Use of Reagent Devices with oth­er devices or Equip­ment” under Reg­u­la­tion (EU) 2017/746 (IVDR).

The IVDR already impos­es clear oblig­a­tions on man­u­fac­tur­ers of com­bi­na­to­r­i­al devices. For exam­ple, annex I, sec­tion 13.1 requires that the whole com­bi­na­tion — includ­ing the con­nec­tion sys­tem — is safe and does not impair device per­for­mance; annex II, sec­tion 6.5(d) demands doc­u­ment­ed proof of con­for­mi­ty when a device oper­ates in con­junc­tion with oth­er equipment.

The posi­tion paper builds on these require­ments by dis­tin­guish­ing between closed sys­tems (defined instrument–reagent com­bi­na­tions) and open sys­tems (gen­er­al lab­o­ra­to­ry equip­ment from any brand). For closed sys­tems, full per­for­mance eval­u­a­tion is required for at least one com­bi­na­tion; equiv­a­lence must be demon­strat­ed for fur­ther com­bi­na­tions. For open sys­tems, man­u­fac­tur­ers must define crit­i­cal equip­ment spec­i­fi­ca­tions and con­duct per­for­mance eval­u­a­tion using a rep­re­sen­ta­tive instrument.

The paper iden­ti­fies three pil­lars man­u­fac­tur­ers must address: robust risk assess­ment and per­for­mance eval­u­a­tion, clear and action­able labelling, and ongo­ing post-mar­ket sur­veil­lance of com­bi­na­to­r­i­al work­flows per IVDR arti­cle 78 and annex III.

Take­away: Man­u­fac­tur­ers claim­ing com­bi­na­to­r­i­al use should review their tech­ni­cal doc­u­men­ta­tion against these expec­ta­tions before their next noti­fied body interaction.

Source: Team-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Team-NB posi­tion paper — When com­pan­ion-diag­nos­tic changes require noti­fied-body approval

Team-NB posi­tion papers on MDR and IVDR tech­ni­cal documentation