This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.
This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design7 or substantial changes to the approved quality system or the product-range covered
that are part of the conformity assessment process and surveillance defined by the relevant notified body under the IVDD.
One of the most important guidance for EU IVDR has just been released! In includes:
– Assessment whether changes are ‘significant changes in the design or intended purpose’ in accordance with IVDR Article 110(3)
– Changes not concerning the design or intended purpose
– Changes in the design or intended purpose
Flowcharts:
– Changes in the intended purpose – Chart A
– Changes in the design – Charts B to E
– Software changes – Chart C
– Changes related to an ingredient or material – Chart D