In May 2023, the Medical Device Coordination Group (MDCG) issued 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. These significant changes are changes in design or intended purpose of medical devices. Some of these changes are deemed significant, while others are considered non-significant. Products holding certificates under the old EU directives are allowed to remain on the market during the transition to the new Medical Device Regulations (MDR), as long as they do not undergo any significant changes. This approach helps ensure a smooth transition and compliance with the evolving regulatory framework. 

“Significant changes” in the context of the EU Medical Device Regulation (MDR) refer to changes in the design or intended purpose of a medical device. Two conditions must be met for a change to be considered significant: 

1. There is a change in the design or intended purpose. 
2. The change is significant. 

Changes unrelated to the design or intended purpose are out of the scope of Article 120(3) of the MDR. According to the Medical Device Coordination Group (MDCG), changes in the manufacturer’s organization or manufacturing process, as well as adjustments to the quality management system (e.g., changes in monitoring and control of production and operational environment), are generally not considered changes in design or intended purpose. 

Changes to the design or intended purpose 

1. Significant changes in the intended purpose 
2. Significant changes in the design 
3. Software significant changes 
4. Significant changes related to a substance or material 
5. Significant changes related to sterilization 

“Significant changes in the intended purpose” of a medical device involve the following key elements: 

1. Extension of the Intended Purpose: 

• Inclusion of additional or new indications for use. 
• Addition of new clinical conditions for which the device can be utilized. 

2. Expansion to a New User or Patient Population: 

• Inclusion of an additional or new target population. 
• Introduction of a new user, for example, a shift from professional use to layman use. 

3. Introduction of a New Way of Clinical Application: 

• Addition of new applications, potentially involving different stages or severities of a disease. 
• Inclusion of new anatomical sites for device application. 
• Adoption of a new delivery pathway or deployment method for the device. 

These changes are considered significant because they can impact the device’s scope, application, and potential risks and benefits. Manufacturers must carefully evaluate and document these changes to ensure compliance with regulatory requirements and to safeguard the safety and efficacy of the device in its intended use. 

“Significant changes in the design” of a medical device, according to the EU Medical Device Regulation, encompass the following scenarios: 

1. Change of Design Affecting Control Mechanism, Operating Principle, Source of Energy, or Alarm Systems: 

• Transition from manual to software-driven operation. 
• Alteration of the measuring function, wavelength, or light emission. 
• Silencing, removing, or adding an alarm system. 

2. Change Adversely Affecting Safety, Performance, and Risk/Benefit Ratio: 

• Alteration of device dimensions or design characteristics outside current specifications. 
• Introduction of new sensors with a different working principle. 
• Removal of a design and development input. 
• Modification to mechanisms preventing the reflux of substances. 

These examples highlight modifications that are considered significant changes in the design of a medical device. Manufacturers should thoroughly evaluate such changes to ensure they comply with regulatory requirements and do not compromise the safety or performance of the device. 

“Software significant changes” in the context of medical devices encompass the following scenarios: 

1. New or Major Change of Operating System or Component: 

• Introduction of a new operating system or any major change to a component (beyond minor changes), for example, transitioning from Linux to Windows, iOS, or Android, or upgrading to a new version of an operating system (e.g., Windows 10 to Windows 11) if it requires modification to the device software. 

2. New or Major Modification of Architecture: 

• Significant alterations to the architecture of the software. 

3. Change of Algorithm Impacting Operating Principles or Device Control: 

• Alterations to algorithms that impact operating principles or control of the device, potentially affecting diagnosis or therapy. 

4.  Introduction of New Medical Feature or Functionality: 

• Addition of a new medical feature or functionality that may change the diagnosis or therapy delivered to the patient. 

5. New User Interface: 

• Changes to the user interface, such as presenting medical data in a new format or using a new dimension or measuring unit. 
• Transition from keyboard input to touchscreen. 
• Shift from keyboard input to wireless remote control. 

These examples highlight situations where modifications to the software of a medical device are considered significant. Manufacturers should thoroughly assess and address these changes in compliance with regulatory requirements to ensure the safety and effectiveness of the device. 

“Significant changes related to a substance or material” in the context of medical devices include the following situations: 

1. Change to Material or Substance in Implants: 

• Modification to a material or substance that is part of an implant, intended for direct or indirect contact with patient tissue or fluid for more than 30 days, or is part of a surgically invasive device that is absorbed. 

2. Addition or Change of Material of Human/Animal Origin: 

• Introduction or alteration of a material of human/animal origin (e.g., transition from collagen produced from skins to collagen produced from bones). 

3. Change in Toxicological or Biological Risk: 

• Change from a material with low toxicological or biological risk to a material with a higher risk. 

4. New or Changed Substance or Material Adversely Affecting Safety or Performance: 

• Introduction of a new or modified substance or material that adversely affects the safety or performance of the device, thereby negatively impacting the risk/benefit ratio of the device. 

These examples highlight situations where alterations to substances or materials in medical devices are considered significant changes. Manufacturers must carefully assess and manage these changes in accordance with regulatory requirements to ensure the continued safety and effectiveness of the device. 

“Significant changes related to sterilization” for medical devices involve the following scenarios: 

1. Change of Terminal Sterilization Method: 

• Modification of the method used for terminal sterilization, such as transitioning from Ethylene Oxide (ETO) to Gamma radiation. 

2. Change from Biological Indicator to Parametric Release: 

• Change from using a biological indicator to adopting parametric release methods. 

3. Change in Sterility Labeling: 

• Conversion of a device labeled as “non-sterile” to being labeled as “sterile.” 

4. Change in packaging design that affects sterility, stability or microbiological state of the device, including seal integrity 

• Change of the packaging design that has an impact on the sterility, stability, or microbiological state of the device, including considerations of seal integrity. 

5. Changes to Storage or Transportation Conditions: 

• Adjustments to storage or transportation conditions that could adversely affect the sterility or stability of the device. 

It’s important to note that more detailed information can be found in the Medical Device Coordination Group (MDCG) guidance document. Manufacturers should carefully assess and manage these changes in accordance with regulatory guidelines to ensure the continued effectiveness and safety of the sterilization process for the medical device. 

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