How should substantial and significant changes be reported to notified bodies under MDR?

Question

I am seeking clarification on how to interpret and report substantial or significant changes for medical devices under the MDR, particularly for Class IIb and IIa devices.
Section 2.4 of Annex IX states: "The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements referred to in Section 2.2."
I am not sure if this means that adding a new device counts as a substantial change, or if it refers to substantial changes to the devices themselves. Additionally, terms like "substantial" and "significant" changes are used, but I find it difficult to determine exactly where the threshold lies for reporting changes to the notified body. How do others interpret this, and what guidance or processes do you use to determine when changes must be reported?

Dr. Oliver Eidel · Accepted Answer

From our experience, the interpretation of what counts as a substantial or significant change really depends on your notified body (NB). We generally treat any substantial change to the device itself as reportable, especially if it could affect safety, performance, or intended use. For minor updates with no risk change for the user, we document a short disclaimer in our internal records explaining why we don't consider them reportable.
The MDR is not very clear on this, and different NBs may have their own lists or guidance. For example, our NB provided a list of changes that must be notified, covering product, QMS, and organizational changes. When in doubt, we refer to MDCG 2020-3 for guidance on significant changes and use that decision tree for both pre- and post-certification. If we report a change and the NB determines it's not substantial, we keep that as justification for handling similar changes internally in the future.
In practice, we aim to only report changes that could affect safety or performance, or that add new products not substantially similar to existing ones. Surveillance audits will often cover new but substantially similar products. Ultimately, a robust QMS and clear internal process for documenting risk assessments and justifications for each change is essential to stay compliant and avoid unnecessary reporting.

Answer

We've found that notified bodies can have quite different thresholds for what they expect to be reported under 'substantial' or 'significant' changes. Our internal process is to use a flowchart based on MDCG 2020-3 to assess whether a change might be significant enough to report. We also try to get feedback from our notified body during audits to refine our understanding.
For adding new products, if they're substantially the same as what's already certified, our NB has been comfortable just reviewing them at the next surveillance audit. But for product changes, it's less clear, and we tend to err on the side of caution if there's any doubt about impact on safety or performance.
It's a grey area, but as long as you have a documented process for evaluating changes and justifying your decisions, most NBs seem satisfied.

Answer

Our notified body (Kiwa-Dare) provided a list of examples for substantial changes that must be notified, including product, QMS, and organizational changes. We've reported product changes in the past that were reviewed as 'not substantial', and now we use that feedback as justification for similar future changes without reporting them. Their interpretation for Class IIb is pretty lenient—they mainly want to be notified of changes to the device-range covered, so the amount of reportable design changes is quite low.

Answer

It really depends on how your notified body interprets the rules. The intent behind the MDR requirements is to provide extra safety for users, but it can make compliance more difficult for manufacturers. There's no standard process—some NBs are stricter, some are more lenient. Our approach has been to keep a robust QMS and detailed documentation. Whenever in doubt, we include a justification in our records for why something was or wasn't reported.

How should substantial and significant changes be reported to notified bodies under MDR?

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