Regulatory Open Forum

Hi Eric

It sounds like you are CE marking an IVD Kit – without knowing what the cartridge is used for (intended use) – The outer carton should reflect the labeling of the 'Kit' i.e. it should specify all of the contents. This is where it is possible then to specify which component is sterile or not.

Each component within the kit should then have it's own label (as you mention). Quite often the lancet may be manufactured and CE marked by the Supplier. In which case you leave their labeling, which should be CE compliant from that Manufacturer (refer to Annex I sec 20.s)).

The IFU in the Kit box again should reflect the Kit that you are supplying. Again you can be clear within the IFU what component you are CE marking as Legal Manufacturer, and what component may be CE marked by another Legal Manufacturer (e.g. lancet) (refer to Annex I sec 20.ag)).

It is worth checking all points under IVDR Annex I. sec 20. to ensure you have all requirements covered.

Note, I presume that the Kit has an intended use that would make it Class B, C, or D under the IVDR. In other words, your NB will review and confirm your labeling during their certification process. The CE mark on the Kit label would bear the NB number (as well as the CE on the cartridge label).

Please reach out if you need further support.

Hi Eric

It sounds like you are CE marking an IVD Kit – without knowing what the cartridge is used for (intended use) – The outer carton should reflect the labeling of the 'Kit' i.e. it should specify all of the contents. This is where it is possible then to specify which component is sterile or not.

Each component within the kit should then have it's own label (as you mention). Quite often the lancet may be manufactured and CE marked by the Supplier. In which case you leave their labeling, which should be CE compliant from that Manufacturer (refer to Annex I sec 20.s)).

The IFU in the Kit box again should reflect the Kit that you are supplying. Again you can be clear within the IFU what component you are CE marking as Legal Manufacturer, and what component may be CE marked by another Legal Manufacturer (e.g. lancet) (refer to Annex I sec 20.ag)).

It is worth checking all points under IVDR Annex I. sec 20. to ensure you have all requirements covered.

Note, I presume that the Kit has an intended use that would make it Class B, C, or D under the IVDR. In other words, your NB will review and confirm your labeling during their certification process. The CE mark on the Kit label would bear the NB number (as well as the CE on the cartridge label).

Please reach out if you need further support.