|Theme||Significant change under the transitional provisions|
|Products concerned||IVD : legacy devices|
This guidance is intended to provide clarification on the concept of “significant change” in the design and purpose of the IVD, under the transitional arrangements provided for in Article 110 of Regulation (EU) 2017/746..
It is intended for manufacturers of IVDs that are compliant with Directive 98/79/EC and that are placed on the market or put into service after May 26, 2022.
Various flowcharts are provided in the appendix to help determine whether a change is considered significant.