There has been an update in the guidance document MDCG 2020-16 concerning the classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. During this third revision, one can note there have been a few updates to this document.
The most significant update is in the definitions section where there has been the inclusion of the ‘Kit’ definition. According to the guidance document, this means 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.
There have also been some revisions when it comes to the specific rules of the IVDR. The sections discussing Rule 3a and Rule 6 both feature a revision to the examples, while the sections discussing Rule 4a and Rule 5c have been revised all together.
The updated guidance can be accessed using the following link
