Significant change, or not? We can guide you.
REGULATORY AFFAIRS CONSULTING
Some submissions are just tricky. Some are huge, with major downstream impacts.
Notified Bodies know that these change projects happen, but they expect information to be presented in a particular way. Our experience brings this to you.
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In the EU regulatory sphere, a “substantial” change is one that typically prompts assessment by the notified body. This could be an on-site audit or a remote technical documentation audit, and may or may not result in re-issue of the certificate.
Whether a change is “significant” or not relates to the transitional provisions of the MDR or IVDR. Article 120 of MDR (IVDR Article 110 is analogous) states that legacy devices can continue to be placed on the market until the transition period ends “provided there are no significant changes in the design and intended purpose“.
For interpretation of what is significant, consider MDCG 2020-3 for MDR and MDCG 2022-6 for IVDR.
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Notified bodies have their own requirements for what to report and how, so check with them.
In general though, you should submit notifications when you plan to make a change that you have evaluated to be substantial and/or significant, and if you think it is borderline.
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This depends on factors such as the device classification, the conformity assessment route and the nature of the change.
The details count here. We can help you with interpretation.
OUR PEOPLE
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years at a leading notified body.
“When I was at BSI, navigating changes was one of the hardest things for my clients - but so easy for me. Through Brightbark Cranberry, I can bring the clarity of that insider knowledge, without the impartiality constraints that Notified Bodies have.”
- Joseph Langley
SERVICES
Every engagement is unique, and we tailor a bespoke set of deliverables to every project.
WE CAN
Help you set up the project for regulatory success
Advise on strategy
Drive key deliverables for regulatory submission
Write documentation
POTENTIAL PROJECTS
Packaging component / process change
Remediation of risk management files
Remediation of design control documentation
Labelling changes (e.g. EU Rep, CH Rep, Distributor, address changes)
Systematic response to audit findings
Overhaul of clinical evaluations
EXAMPLE DELIVERABLES
Classification rationales
Requirements checklists
Lists of applied standards
Labelling and instructions for use (IFU)
Design control - user needs, design inputs, input/output matrix
Verification & validation planning
Risk management files including risk analysis and benefit-risk analysis
Performance testing protocols and reports
Shelf life testing protocols and reports
Transit testing protocols and reports
Biological evaluation protocols and reports
Clinical evaluation protocols and reports
CMR (GSPR 10.4) justifications
Ready to accelerate your change projects?
QUESTIONS & ANSWERS
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Yes. Notified Bodies need information about your suppliers and subcontractors. Whilst this informs a number of audit aspects, it is most critical for NBs to plan unannounced audits, which can be at any subcontractor or supplier - the selection is typically made based on which site will give the best opportunity to witness high risk manufacturing activities.
Our director, Joseph Langley, previously authored guidance on this topic for BSI.
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It depends on the classification of the device.
For lower classification devices, which fall only under an Annex IX Chapter 1 & 3 (QMS) certificate, there is typically more freedom to make changes without prompting assessment. However, it is often advisory to inform. your NB, in case the change does impact the certificate scope.
For higher classification devices, falling under an Annex IX Chapter 2 (technical documentation assessment) certificate, the NB should be informed any change to indications before implementation, as it is quite likely to require additional assessment.
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This also depends on device classification, but we would generally advise all examples of a change to a PMCF study protocol should be sent to the NB in advance.
Clinical requirements are greater than ever in the EU, and particularly for higher classified devices, NBs don’t want to be caught out.
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Page last updated: July 2026.