23 Jul MDCG 2020-3
MDCG 2020-3 – Guidance on significant changes
In May 2023 the Medical Device Coordination Group updated the MDCG document MDCG 2020-3 Rev.1. This document provides guidance on significant changes concerning the transitional provisions under Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR). This document focuses on legacy devices, which are medical devices covered by valid certificates under the Medical Device Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) that continue to be marketed or put into service until the extended deadlines of December 2027 or December 2028, as applicable.
Definition of a Significant Change:
A significant change in the design or intended purpose of a device is critical to determine whether the device can continue to be placed on the market under its existing certification. According to the guidance, a significant change includes two cumulative elements:
- There is a change in the design or intended purpose.
- The change is significant.
Changes that do not concern the design or intended purpose are out of the scope of Article 120(3). Similarly, changes required to comply with other Union legislation are also out of scope if the risk/benefit ratio of the device is not negatively affected.
Types of Changes:
The guidance provides detailed criteria to assess whether a change is significant, utilizing several flowcharts to aid in the decision-making process. These criteria cover various aspects, including changes in the intended purpose, design, software, substances or materials, and sterilization methods.
Changes in the Intended Purpose
Non-significant changes include:
- Restriction or deletion of certain indications or applications.
- Restriction of the target population.
Significant changes include:
- Additional or new indications or clinical conditions.
- New user or patient populations.
- New ways of clinical application, such as new anatomical sites or delivery methods.
Changes in the Design
Non-significant changes include:
- Minor design modifications that do not alter the built-in control mechanisms, operating principles, source of energy, or alarm systems.
- Changes to improve ergonomic comfort or aesthetic presentation without altering functionality.
- Updates within the currently certified range, such as new variants within existing specifications.
Significant changes include:
- Alterations to the built-in control mechanisms, operating principles, source of energy, or alarm systems.
- Changes that adversely affect the safety or performance and negatively impact the risk/benefit ratio of the device.
- Major changes in the design, such as changes in device dimensions or new sensors with different working principles.
Software Changes
Non-significant changes include:
- Bug fixes, performance improvements, and security updates.
- Updates to the user interface that do not affect usability or add new functions.
Significant changes include:
- Major modifications to the software architecture or algorithms that impact the device’s operating principles.
- Introduction of new medical features or functionalities that alter diagnosis or therapy.
Changes in Substances or Materials
Non-significant changes include:
- Substitution of materials within defined specifications.
- Changes that do not affect the safety or performance of the device.
Significant changes include:
- Changes to materials that are in contact with patient tissue or fluids for more than 30 days.
- Introduction of materials of human or animal origin.
- Changes that increase the toxicological or biological risk.
Sterilization Changes
Non-significant changes include:
- Changes to sterilization cycle parameters.
- New sterilization vendors or chambers without altering sterilization methods.
Significant changes include:
- Changes in the terminal sterilization method.
- Changes affecting the sterility assurance level or packaging design that impact sterility.
Impact on Device Certification
If a change is deemed significant, the device cannot be placed on the market under the AIMDD/MDD certification and must be assessed for compliance under the MDR. Manufacturers must document the assessment of changes and provide evidence that non-significant changes do not affect the design or intended purpose. Notified Bodies must verify changes as part of their surveillance activities or following manufacturer submissions for prior approval.
Conclusion:
In conclusion, the MDCG 2020-3 Rev. 1 guidance provides a detailed and structured approach for medical device manufacturers to determine the significance of changes in design or intended purpose for legacy devices under the transitional provisions of the MDR. By clearly defining what constitutes a significant change and offering practical flowcharts and examples, the guidance ensures manufacturers can make informed decisions that maintain compliance and uphold device safety and performance.
This document is essential for manufacturers navigating the extended transition periods, allowing them to continue marketing legacy devices without compromising regulatory requirements. Proper adherence to these guidelines will facilitate a smoother transition to the full implementation of the MDR, ensuring that all medical devices on the market continue to meet high standards of safety and effectiveness. Manufacturers must stay vigilant and maintain thorough documentation of all changes to their devices, working closely with notified bodies to ensure compliance and avoid disruptions in market availability.
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