2024: MDR/IVDR Legacy Device Significant Change Tool

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MDR/IVDR Legacy Device
Change Assessment Tool

Assess if your device change is non-significant, allowing it to maintain its legacy status. Or if the change is significant, requiring MDR/IVDR CE Marking.

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Table of Contents

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.

Background

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.

Disclaimer

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

What type of change is occuring?

What type of change is occurring to the product information?

What type of change is occurring to the manufacturing process?

NOTE: Examples of changes that do not affect the intended use, sterilization or design include the following: relocation or addition of new manufacturing sites, changing the supplier of a material, substance or component, provided the specifications of the new material, substance or component do not change, or a new process validation as part of manufacturing improvements or scale-up of manufacturing.

What type of change is occurring to the QMS?

NOTE: An example of a change that does not impact intended use, material/substance, sterilization is a change in the monitoring and control of production and operations environment.

Is this a change related to corrective actions (including changes to shelf-life)?

NOTE: This question relates to design and intended use changes that are resulting from a corrective action and have been assessed and accepted by the competent authority of the Member State in which the manufacturer or its authorized representative has its registered place of business.

The assessment and acceptance of an FSCA by by a competent authority does not exempt the manufacturer from submitting changes to the relevant notified body under the AIMDD/MDD nor the notified body from assessing the change in line with the agreed arrangements.

Is this a change related to the intended purpose?

What type of change is occurring to the intended purpose?

Is this a design change?

What type of change is occurring to the design?

NOTE: Examples of design changes that do not fall into these categories (as long as they do not negatively affect the risk/benefit ratio of the device) are change of color of an assembly or device, change to design for an easier operation, modification of a part (e.g. a connector) to adhere to a new or revised standard, change of the swab intended to be used with a device or change from refrigerated to room temperature storage conditions.

Examples of changes that fall into these categories include the change from manual to software driven device, reduction of battery operating time, change of instructions for use to refer to reduced sensitivity of the device based on data obtained as a result of post-market surveillance or change from immunofluorescence to ELISA.

See MDCG 2020-3 (MDs) or MDCG 2022-6 (IVDs) for more examples.

Is this a software change?

NOTE: This item may impact standalone software or a device that incorporates software.

What type of change is occurring to the software?

Is an ingredient, substance or material change occurring?

What type of change is occurring to the ingredient, substance or material?

Is the product a Medical Device or an IVD?

Is a terminal sterilization method changing or is the packaging design changing, impacting the sterilization of the device (including shelf-life changes)?

Is a sterilization method changing or is the packaging design changing, impacting the sterilization of the device (including shelf-life changes)?

What type of change is occurring to the device sterilization?

What type of change is occurring to the IVD sterilization?

Is the shelf-life extension validated according to protocols approved by the notified body?

Change is Significant

The change is considered significant per Art. 120(3c), point (b) MDR or per IVDR Art. 110(3).

This means the device will not maintain 'legacy' status and must be certified under the MDR or IVDR to market with this change.

Change is Non-Significant

The change is considered a non-significant change per Art. 120(3c), point (b) MDR or per IVDR Art. 110(3).

If a change is non-significant, allowing the device to maintain 'legacy' status, it should still be documented in the manufacturer's QMS and may still need to be reported to the Notified Body.

Change is Non-Significant

The change is considered a non-significant change per Art. 120(3c), point (b) MDR or per IVDR Art. 110(3).

If a change is non-significant, allowing the device to maintain 'legacy' status, it should still be documented in the manufacturer's QMS. Further, QMS changes continue to be subject to the agreed notification procedure between manufacturer and notified body.