Theme Significant change under the transitional provisions
Target Audience Manufacturer  
Products concerned IVD : legacy devices
Documents mentioned

Regulation (EU) 2017/746

Directive 98/79/EC

MDCG 2020-3

Regulation (EC) 1272/2008

Regulation (EC) No 1907/2006

Q&A 9 of the CAMD’s FAQ – IVDR Transitional provisions

Q&A 15 of CAMD’s FAQ – IVDR Transitional provisions


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.