Guidance on IVDR Significant Changes

Jul 19, 2022 | News

Guidance on IVDR Significant ChangesMedical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR, that outlines what constitutes a significant change to a medical device. This document is vital for IVD manufacturers as it clarifies when a change to a device may require notification to, or approval from, a regulatory authority.

There are three main types of changes that are considered significant under the guidance:

  • Changes to the intended use of the device
  • Changes to the device design
  • Changes to the software

Other types of changes that may be considered significant include:

  • Changes to ingredients or materials
  • Changes to sterilization methods
  • Changes to packaging design

The effects these changes will have on the device's safety and performance will be considered when determining whether or not the change is significant.

Manufacturers need to be aware of these guidelines when making changes to their devices, as failure to follow them may result in delays in getting the IVD to market or even a recall. If you are unsure whether a change to your medical device is significant, you should consult with a qualified regulatory affairs consultant like MEDIcept if ever in doubt.

When making a change to a medical device, manufacturers must first assess whether the change is significant. No further action is required if the change is considered non-significant. If the change is determined to be substantial, manufacturers must notify the relevant regulatory authority and provide information on the change, as well as evidence to support why the change does not adversely affect the safety or performance of the device.

The MDCG guidance clarifies what constitutes a significant change to a medical device. This is important for manufacturers as it helps to ensure that changes to devices do not alter the performance of the device. Medical device manufacturers can use the charts provided within Annex to determine whether a change is significant or not by examining whether the change alters the operating principle, adversely affects safety or performance, or negatively affects the risk/benefit ratio. If any of these criteria are met, the change is considered significant, and the manufacturer must follow the requirements of the IVDR for that change. These charts can also help medical device manufacturers save time and resources by avoiding changes wherever they are unnecessary.

MEDIcept is your go-to source for comprehensive medical device regulatory solutions. We have a long history of success in helping clients achieve and maintain compliance with global regulations. Our team of experts is available to help you navigate the MDCG 2022-6 guidance, ensuring your products meet all requirements. Contact us today if you have any questions about the MDCG guidance, about significant changes to medical devices in general, or to get started on your medical device compliance journey and we can help you every step of the way.


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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.

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