MDCG 2022-6: Significant changes under the IVDR, explained
The IVD equivalent of MDCG 2020-3: which changes cost your legacy IVD its transition period.
MDCG 2022-6 is the IVDR counterpart to the MDR significant-change guidance. It helps legacy-IVD manufacturers decide whether a proposed change may be made while the device remains on the transitional route. A change that significantly alters the design or intended purpose ends that route for the changed device; administrative and manufacturing changes usually do not.
Who this applies to
This guidance applies to manufacturers placing legacy IVDs on the EU market under the transitional provisions in IVDR Article 110(3). That includes devices with an IVDD certificate and devices that were self-declared under the IVDD but require notified-body involvement under the IVDR.
The guidance was published in May 2022. The transition deadlines and entry conditions have since been amended, most recently by Regulation (EU) 2024/1860. Use the current version of Article 110 to decide whether a device remains eligible for transition; use MDCG 2022-6 to assess the separate question of whether a proposed change is significant.
Start with the right baseline
Compare the proposed device with the IVDD-compliant design and intended purpose that existed on 26 May 2022. The intended purpose includes the use stated in the label, instructions and promotional material. A change is not significant merely because it touches a controlled document: first decide whether it changes the design or intended purpose, then assess its significance.
The manufacturer owns and documents that assessment. For devices covered by an IVDD certificate, follow the agreed change-notification process and involve the notified body when required. A notified body may confirm that a change is non-significant, but it cannot use that confirmation to issue a new IVDD certificate.
The changes most likely to cross the line
MDCG 2022-6 provides a main flowchart and sub-charts for intended purpose, assay design, software and materials. The recurring pattern is:
Usually significant |
Usually not significant |
|---|---|
Adding an analyte, genotype, specimen type, function or target population |
Narrowing the intended purpose without introducing a new risk |
Changing between screening, diagnostic, confirmatory, monitoring, qualitative or quantitative use |
Correcting spelling or making purely editorial changes |
Changing the intended user, such as professional use to self-testing |
Manufacturer name, address, legal form or authorised-representative changes |
A new assay principle, major architecture change or algorithm change that affects performance or interpretation |
A supplier change where the material specification remains unchanged |
Material or reagent changes that adversely affect performance or introduce new risks |
Manufacturing scale-up or process validation that preserves the approved design |
Corrective actions accepted by the competent authority are generally treated as non-significant for this transitional assessment. That does not remove the obligation to control, validate and document the change.
Software needs two assessments
For software changes, assess both the software itself and the device result. New or major operating-system, architecture, database or interoperability changes can be significant when they affect performance, safety or interpretation of data. A change to an algorithm is significant when it changes the operating principle or adversely affects performance.
Bug fixes, security updates, user-interface changes and efficiency improvements can be non-significant, but the label is not decisive. Record the regression evidence and risk analysis showing why the change does not adversely affect the device.
What this means for you, practically
- Confirm transition eligibility first. Record the current Article 110 route, deadlines, notified-body milestones and device scope before assessing the change.
- Freeze the 26 May 2022 baseline. Keep the intended purpose, design specifications, assay architecture, software version and applicable certificate together.
- Walk every relevant chart. A change is non-significant only when the main chart and all applicable sub-charts end there.
- Attach evidence to the change record. Include risk analysis, verification or validation, labelling impact and the reason each flowchart answer applies.
- Escalate before implementation. Follow the notified-body agreement for certified devices; if the desired change is significant, plan the IVDR conformity route for the changed device.
Related MDCG guidance
Related resources
MDCG guidance
MDCG 2020-3: Significant changes to legacy devices
Which design or intended-purpose changes make your MDD device lose its transition-period grace — and which don't.
Change Evaluation List
Sven Piechottka
MDCG guidance
MDCG 2020-6: Sufficient clinical evidence for legacy devices
The evidence bar your MDD-era device must clear for MDR certification, and which data sources count.
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