kit

IVDR, Article 2(11) First adopted 2017-04-05

a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof

Pharma Directive proposal, Article 4(20) Own wording Proposal proposed 2023-04-26

a set of components that are packaged together and intended any preparation to be used reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to perform a specific in vitro diagnostic examination, or a part thereof its administration

Compared with IVDR: struck words are only in IVDR, marked words only here.

CPR, Article 3(17) Own wording adopted 2024-11-27

a product placed on the market by a single economic operator as a set of components that are packaged together and at least two separate items, none of which needs to be a product itself, intended to be used to perform a specific in vitro diagnostic examination, or a part thereof incorporated together into construction works

Compared with IVDR: struck words are only in IVDR, marked words only here.