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The MDCG guidance document on significant changes under MDR Article 120(3) has been updated. MDCG 2020-3 Rev. 1 can be found: HERE
The Document was updated to:
- align to the equivalent IVDR guidance MDCG 2022-2,
- account for the extension to the MDR transitional provisions (EU 2023/607), and
- to take “into account the experience gained with the application of the original version so far”.
The scope of the document is related to significant changes to a device design or intended purpose as they relate to the MDR transitional provisions. All other types of changes are out of the scope of Article 120(3) MDR.
Non-significant changes to the device design or intended purpose can be made to an MDD/AIMDD legacy device without having to certify under the MDR. Of course, the device should still conform to the MDD/AIMDD, and manufacturers should document all changes made.
CE Marking certificates should not be amended. However, the Notified Body may confirm in writing that the implementation of the change does not represent a significant change in design or intended purpose under Article 120(3c), point (b) MDR and that the related AIMDD/MDD certificate remains valid until the end of the transition period.
MDCG 2020-3 Rev. 1 advises that such a statement from the Notified Body does not constitute issuance of a “supplemented certificate”, which is prohibited for legacy devices.
Changes to Manufacturing Process or Organization
Changes to the manufacturing process or the manufacturer’s organization are not generally considered to be changes to the design or intended purpose of a device. This is the case even if it updates the information supplied with the device, e.g., instructions for use.
Examples of such non-significant changes are:
- To the manufacturer’s name, address, or legal form, including due to a merger or acquisition,
- Changes in relation to the authorized representative,
- Relocation or addition of a new manufacturer site, including when it affects subcontractors or suppliers,
- Changing the supplier of a material, substance, or component, provided the specifications of the new material, substance or component do not change,
- New process validation as part of manufacturing improvements or scale-up of manufacturing,
- Changes of the QMS, such as changes in the monitoring and control of production and operations environment, generally do not impact the design or intended purpose either, provided that the conditions for which the conformity assessment certification was granted are maintained.
Changes to the design or intended purpose
Examples of changes considered non-significant
- Clarifications of intended purpose, population, or clinical application in the information supplied with the device, if in line with the original certification
- Limitation of the intended purpose, e.g., restriction of an indication or target population
- Changes to the design that do not alter the device’s built-in control mechanism, operating principle, source of energy, or alarm systems. For example:
- Modification of a part to adhere to a new or revised standard
- Change to design for an easier operation, such as a change to the thumb rest of injection syringe, change to lids, or change to the mechanism of loading substances
- Changes to outer packaging (e.g., size, material, layout) that do not adversely affect the stability, sterility, or microbial state of the device
- Software security updates
- Appearance of a software user interface provided it does not negatively affect the usability or add new functions
- Extension of the shelf life validated by protocols approved by the notified body
- Change of the sterilisation cycle parameters
The above changes are valid only if the risk/benefit ratio is not negatively affected.
Examples of changes considered significant
- Change of the design that alters the device’s built-in control mechanism, operating principle, source of energy, or alarm systems. For example:
- Change from manual to software-driven device
- Change to the measuring function, wavelength, or light emission
- Silencing/removing/adding of an alarm system
- Change that may adversely affect the safety or performance and negatively affect the risk/benefit ratio of a device. For example:
- Change to the device dimension or design characteristics outside of current specifications
- New sensors with a different working principle
- Removal of a design and development input
- New user interface, e.g., keyboard input to touchscreen
- Change to a material or substance which is part of an implant and intended for direct or indirect contact with patient tissue or fluid for more than 30 days, or is part of a surgically invasive device which is absorbed
- Change of the terminal sterilization method (e.g. ETO to Gamma)
Significant changes to the design or intended purpose will push the device out of its legacy device status and into MDR certification.
Change Decision Tree Flow Charts
MDCG 2020-3 Rev. 1 provides flowcharts to help assess if a change is significant or not under MDR Article 120(3).
The flowcharts start on page 16.
An intended purpose or design change is considered non-significant if the answer to every question in a sub-chart leads to “non-significant change” also when returning to the main chart.
However, if any sub-chart delivers the result “significant change”, the change being assessed is a “significant change in design or intended purpose” according to Article 120(3c), point (b) MDR.
When in doubt, manufacturers may discuss the proposed change with their Notified Body.