Prior to making a change to your ‘legacy’ device, you must determine if it is considered ‘significant’ or not.
Our tool helps assess if the change is non-significant, allowing it to remain a legacy device. Or if the change is considered significant, and therefore pushes the device into MDR/IVDR designation.
The tool incorporates decision trees from the MDCG guidance documents, along with additional examples of significant and non-significant changes. It should allow you to easily understand if a change is considered significant or not.
NOTE: please refer to the MDCG guidances (linked below) for additional examples; and as the fundamental resource for change assessment under the MDR/IVDR’s transition provisions.
Legacy devices are those that hold valid CE Marking under the MDD/AIMDD/IVDD and may continue to be placed onto the market.
For devices to maintain legacy status, no significant changes to the design or intended purpose can occur after the MDR and IVDR Dates of Application:
- 26 May 2021 (medical devices)
- 26 May 2022 (IVDs)
This is per the legacy device transition articles:
- MDR Art. 120(3c), point (b)
- IVDR Art. 110(3)
MDCG Guidance for Legacy Device Changes
If a significant change is made, the product must be certified to the MDR of IVDR before the change can be incorporated. However, the regulations do not identify what constitutes a significant change to the intended purpose or design.
Instead, industry should refer to the MDCG guidance documents:
- MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
- MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
The MDCG guidances cover:
- Further explanation as to what constitutes a ‘significant’ change to the intended purpose or design
- Examples of changes that are, and are not, considered significant
- Decision trees to help determine if a change is considered significant or not, i.e., to determine if a specific change allows a device to maintain legacy status or requires the device to be certified to the MDR/IVDR
Notifying your Notified Body
There is a difference between a significant change that pushes a device out of its legacy device status, and changes significant enough to inform your Notified Body, Authorized Representative and/or Competent Authority.
A change that is considered non-significant per MDCG 2020-3 and MDCG 2022-6 may still need to be notified to the Notified Body, Authorized Representative or Competent Authority. Manufacturers should follow their change procedure to ensure the proper entities are notified.
In some situations, you may wish to request that your Notified Body issue written confirmation that the change is not considered ‘significant’. For example, changes that result in your product label no longer matching the information on your CE Marking certificate or Declaration of Conformity, neither of which should be reissued after the MDR/IVDR’s date of application.
Further, manufacturers should document the rationale as to why the change is not considered ‘significant’ under the MDR/IVDR transitional provisions.
The change assessments provided below are for reference only. Casus Consulting does not take responsibility for the accuracy of this information. Casus Consulting has taken due care in preparing the legacy device change assessment tool, but we do not guarantee, nor do we assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials.
The legacy device change assessments outlined in the MDCG documents are publicly available on the EU Commission website. Links are provided on this page and individuals should verify the information as published by the EU Commission before taking any action. Further, if there is a question on a specific requirement, users should contact their Notified Body or Competent Authority to confirm.
Legacy Devices: Change Assessment Tool