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 design 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.
It is important to highlight that no issuing of new IVDD certificates is allowed under IVDR Article 110(3)
In particular, if the manufacturer wishes to make a ‘significant change in design or intended purpose’ within the meaning of IVDR Article 110(3), the implementation of such a change would prevent the manufacturer from placing the device on the market under the IVDD in accordance with that provision.