In the world of medical devices, change is inevitable. Whether it’s driven by clinical feedback, new market opportunities, or even strategic positioning, we see it constantly. But we see one type of change cause disproportionate disruption: seemingly “minor” modifications to a device, such as its intended purpose, clinical claims, or warnings.
On the surface, it’s just a small adjustment, a new patient population, or a clearer articulation of clinical value. But under the Medical Device Regulation (MDR), even subtle changes can trigger major downstream effects on your technical documentation. And just as you’re finalising the updates? Another request lands: “Can we also target this for paediatric use?”. This is where the role becomes more than just writing and reviewing.
Why “Minor” Changes Can Create Major Work
Changing the intended purpose or clinical claims of your medical device isn’t just a matter of editing a sentence in the Instructions For Use (IFU). Under the MDR, your device’s intended purpose defines the whole regulatory strategy, from classification to clinical evidence to post-market surveillance. Even well-intentioned updates, like adding a benefit, can have more implications than expected:
- The Clinical Evaluation may need to be re-scoped, re-justified, and possibly expanded with new literature or clinical data
- Risk Management Files must reflect the new use scenarios or user groups
- Post-market activities may require adjustment to capture new data relevant to the updated claims or populations
- Labelling and IFU documents need to be harmonised with the technical and clinical evidence
These implications are not roadblocks, but they do require forethought, alignment, and careful documentation. With the right planning and a structured approach, even complex modifications can be managed smoothly and without disrupting timelines.
Why These Modifications Are Common – and Reasonable
From a business perspective, these changes often make sense. Frequently, in response to market insights, expanding product value, or making claims that better reflect the data available. The changes themselves are usually reasonable and clinically justifiable; the challenge lies in ensuring they’re dealt with in a way that remains compliant.
We commonly see changes evolve from:
- Adjustments in clinical strategy based on new evidence or feedback
- Marketing requests to broaden claims or clarify benefits
- Efforts to align with competitor positioning
The key is to treat these modifications as part of an ongoing regulatory lifecycle, not as one-off edits. With this mindset, changes can be efficiently integrated into documentation without interfering with ongoing projects.
How to Manage Change Without Creating a Compliance Headache
The goal isn’t to resist change, it’s to manage it successfully. Here are three strategies that can help keep modifications under control and aligned with both regulatory requirements and business goals.
1. Start by assessing the modification impact
Before any change is approved, whether it’s a new benefit, a broader indication, or a revised warning, it’s important to assess how that change will affect the Technical File.
A structured impact review should ask:
- Does this expand the scope of the Clinical Evaluation?
- Are any additional risks and risk controls introduced?
- Does this affect the device classification or conformity assessment?
- Will both the PMS and PMCF activities need to be revised?
Tip: Use a “Change Impact Matrix” to visualise which sections of the Technical File need to be reviewed or updated based on the type of modification being proposed.
2. Design your documentation with adaptability in mind
Regulatory documents should not be seen as static, one-off submissions. They are living files that need to house ongoing change.
That’s why it helps to build flexibility into the way documentation is written and sustained:
- Use modular templates that allow for efficient section-by-section updates
- Maintain centralised source data and references to avoid duplication of effort
- Link documentation components (CER, Risk Management File, IFU, PMS) to keep those updates aligned
Tip: A shared document update checklist can help teams remember to harmonise related files. This will be especially important when multiple stakeholders are involved in a project.
3. Involve regulatory review early
Many challenges arise when regulatory impact is considered only after a change has been proposed or implemented. A label gets updated, a new claim is added to marketing material, or an expanded user group is announced, and only then does the technical team become involved to implement the change.
The earlier the regulatory review is included, the better. This would then allow for:
- An assessment into what clinical evidence would be needed to support the change
- An evaluation of whether the benefit-risk profile shifts
- Identifying whether the change qualifies as “significant” under the MDR
Tip: Even a short, early-stage discussion can prevent unnecessary rework or submission delays later.
Final Thought: Change Is Normal – Managing It Well Is the Goal
Device modifications are a natural part of product development and lifecycle management. Under the MDR, the threshold for what qualifies as a “significant” change is tighter, but that doesn’t mean changes can’t be made. It just means they need to be evaluated, documented, and implemented with care.
The challenge isn’t in avoiding change; it’s in building the right systems, habits, and review processes so that change becomes manageable and not disruptive. With this approach in mind, it is entirely possible to keep compliance on track while continuing to evolve your product strategy.
Need Support Navigating Device Modifications?
At Mantra Systems, we specialise in helping medical device companies manage evolving product strategies without compromising compliance. Whether you’re expanding intended use, revising benefit claims, or updating risk communications, we’ll help you assess the impact, implement the right updates, and stay on track.
