Hi all,
We have a List B Annex II IVD assay kit and a Self-declared instrument. First, the instrument was made as a self-declared CE IVD and this instrument will be used as part of the assay system, where the assay is Annex II List B IVD. The idea is to sell the instrument individually and also as part of the assay.
1. Can't we use such instrument (extraction kit instrument - Annex III, self-declared CE IVD) with the assay (Annex II List B classified)?
2. We heard from a Consultant that to use the instrument with assay, the instrument must be classified as Annex II List B instrument so that it can be sold as part of the List B assay and separately.
His point is - a self-declared Annex III IVD can't be used as part of Annex II List B IVD assay. A self-declared CE IVD instrument can be sold as an independent instrument, but not with the Annex II List B assay.
Our argument is that the instrument itself falls under Annex III self-declared IVD, when used with Annex II List B assay, the Notified Body will check all applicable essential principles pertaining to both Assay and the Instrument and can be used with the assay.
Similar approach to US FDA: if a class II 510(k) cleared instrument is made part of a PMA, then instrument will be looked as a Class II instrument only; FDA does not ask manufacturers to reclassify the instrument as Class III, since it is part of a PMA.
Any thoughts?
Thanks,
Sreenu
We have a List B Annex II IVD assay kit and a Self-declared instrument. First, the instrument was made as a self-declared CE IVD and this instrument will be used as part of the assay system, where the assay is Annex II List B IVD. The idea is to sell the instrument individually and also as part of the assay.
1. Can't we use such instrument (extraction kit instrument - Annex III, self-declared CE IVD) with the assay (Annex II List B classified)?
2. We heard from a Consultant that to use the instrument with assay, the instrument must be classified as Annex II List B instrument so that it can be sold as part of the List B assay and separately.
His point is - a self-declared Annex III IVD can't be used as part of Annex II List B IVD assay. A self-declared CE IVD instrument can be sold as an independent instrument, but not with the Annex II List B assay.
Our argument is that the instrument itself falls under Annex III self-declared IVD, when used with Annex II List B assay, the Notified Body will check all applicable essential principles pertaining to both Assay and the Instrument and can be used with the assay.
Similar approach to US FDA: if a class II 510(k) cleared instrument is made part of a PMA, then instrument will be looked as a Class II instrument only; FDA does not ask manufacturers to reclassify the instrument as Class III, since it is part of a PMA.
Any thoughts?
Thanks,
Sreenu
