IVD device conformity assesSment

NEOEMKI LLC. is a notified body for conformity assessment of IVD device according to Directive 98/79/EC.

Any conformity assessment procedure under Directive 98/79/EC must be closed by 26th of May, 2022.

We receive new applications until 30th of September, 2021.

Acceptance of the submitted application is subject to the completeness of the application documentation and our available resources. Application submission before the above deadline does not mean acceptance and contracting automatically.

The conformity assessment main steps are:

  • decision whether the device belongs to IVD products,
  • determination of IVD type the device belong,
  • choosing appropriate conformity assessment procedure according to the type of the IVD device,
  • involvement of a Notified Body, if needed (subject to conformity assessment procedure)
  • follow the procedure to prove conformity with the directive,
  • when conformity proven, CE mark has to be put on product.

The flowcharts above may help with determination of the appropriate assessment procedure:

IVD termék (nem önellenőrzésre szolgáló, nem A vagy B lista)
IVD termék önellenőrzésre szolgáló (kivéve A és B lista)

IVD product (A lista)
IVD product (B lista)

For IVD products other than device for self-testing, non-classified as list „A” or „B”, conformity assessment has to be concluded by the manufacturer itself. Involvement of Notified Body not necessary for these products. Classification of the product must be proven in this case (non self testing, neither list A or B). The product must comply with the Directive 98/79/EC. The manufacturer signs Declaration of Conformity for the product. After successful closure of the conformity procedure CE mark can be put on product.

For self-testing IVD device, and device classified as list „A” or „B” IVD device according to Amendment II. of directive 98/79/EC (with exclusion of device for performance evaluation), manufacturer or EC representative have to involve Notified Body in conformity assessment procedure.