The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR, i.e. 26 May 2022. It is therefore important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’ under Article 110(3) IVDR.
According to Article 110(3) IVDR, changes that do not concern the design or intended purpose are out of the scope. Moreover, changes that concern the design or intended purpose only fall under the scope, if they are considered ‘significant’. If a change is not a significant change in design or intended purpose under IVDR Article 110(3), the implantation of such a change is allowed during the transitional period without the need for certification under the IVDR. In such cases, the manufacturer needs to comply with the documentation requirements of the IVDD.
To facilitate a harmonized judgement of the significance of changes, the MDCG 2020-6 guidance provides several flowcharts in the attached annexes, including the chart regarding changes in the intended purpose (Chart A), charts regarding changes in the design (Charts B to E), chart for software changes (Chart C), chart for changes related to an ingredient or material (Chart D), and a chart concerning changes related to sterilization (Chart E).
Attachment: MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.
MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR