Nobody spells this out in the job posting.
You went to school for the science, rigorous risk assessments, and clinical thinking — yet here you are, afternoons lost to cross-checking labels against risk files, line after line, playing the game of “did I catch everything?”
One inconsistency, and the whole submission could come back for another round. That’s the job as it grinds on, no matter what the training promised.
And here’s the kicker: the data backs up what regulatory teams already know. Medical device claims verification and regulatory document review can consume significant expert time — especially when evidence is spread across multiple documents.
The Regulatory Burden Is Real
Bureaucracy isn’t imaginary. It is measured, counted, and very real.
According to MedTech Europe’s report on administrative burden under the MDR and IVDR, approximately 60% of IVD and medical device manufacturers identify administrative burden and the costs of regulatory approval as the most important regulatory barriers to bringing innovative devices to the EU market. The same report states that more than 70% of manufacturers had to allocate additional resources to regulatory compliance following the introduction of the MDR and IVDR.
Source: MedTech Europe — Report on Administrative Burden under IVDR and MDR
That cost isn’t just a number on a balance sheet. It is your team — real people — spending hours reading document after document, checking references, comparing claims and evidence, and racing the clock.
Incomplete Technical Documentation Creates Another Problem
And when things go wrong, the consequences can be significant.
Team-NB’s 2025 medical device sector survey reports that 65% of submitted MDR files were missing at least half of the required information at the completeness check. For IVDR submissions, 42% of files were reported as missing three-quarters of the required information.
Incomplete documentation can mean additional information requests before the conformity assessment can properly proceed. That means more work for manufacturers, more back-and-forth, and more time spent locating information that may already exist somewhere in the documentation.
Why Medical Device Claims Matter Under the EU MDR
Claims are not simply marketing language. Under the EU Medical Device Regulation, manufacturers must ensure that information provided about a device does not mislead users or patients about the device’s intended purpose, safety or performance.
Article 7 of Regulation (EU) 2017/745 specifically prohibits misleading claims in areas including labelling, instructions for use, advertising and other communications about the device.
Source: Regulation (EU) 2017/745 — Article 7, Claims
That makes claim verification more than a final proofreading exercise. Claims need to be considered alongside the device’s intended purpose, clinical evidence, technical documentation and other relevant regulatory information.
What Makes Medical Device Claims Verification So Difficult?
The information usually exists. The problem is that it can be buried or scattered across the technical documentation.
Claims appear across multiple documents
A regulatory team may need to compare information across Technical Documentation, Clinical Evaluation, IFU and labeling, Risk Management, Performance Evaluation and other supporting documentation.
The MDR requires technical documentation to be presented in a clear, organised, readily searchable and unambiguous manner, while the clinical evaluation requirements connect clinical evidence, intended purpose and manufacturer claims.
Source: Regulation (EU) 2017/745 — Annex II, Technical Documentation
Evidence can be difficult to find
A claim may be supported by information that is technically present in the file, but finding the exact page, paragraph or evidence behind that claim can still take considerable manual effort.
Consistency matters
Maybe the Clinical Evaluation says one thing, while the IFU uses different wording. Maybe a claim does not trace cleanly to the supporting evidence. Maybe information in one part of the technical documentation does not align with another document.
These are exactly the kinds of inconsistencies that become harder to spot when reviewers are spending hours performing repetitive comparisons.
Clinical Evidence and Manufacturer Claims Are Connected
The MDR explicitly connects clinical evaluation with the manufacturer’s claims. Annex XIV requires the clinical evaluation to take into account the manufacturer’s claims concerning the device, while the resulting clinical evidence forms part of the technical documentation.
The regulation also requires clinical evaluation results and the clinical evidence on which they are based to be documented in a clinical evaluation report supporting conformity assessment.
Source: Regulation (EU) 2017/745 — Annex XIV, Clinical Evaluation
In practice, that makes traceability between a claim and its supporting evidence an important part of a defensible regulatory review.
DocuGenius Isn’t Here to Replace Your Expertise
It’s here to give it breathing room again.
Your Rules. Your Control.
Forget the feature checklist for a moment — this is what matters.
With DocuGenius, you set the criteria. Technical Documentation, Clinical Evaluation, IFU and labeling, Risk Management, Performance Evaluation — your rules, as your QMS actually frames them.
No generic templates. No one-size-fits-all logic.
DocuGenius applies your standards directly to your documents. The logic is in your hands. The outcome is yours to own.
Upload the Document. See What’s Met — and What Isn’t.
Routine is the goal here.
You upload a file. DocuGenius checks it against your criteria and shows you, requirement by requirement, exactly what is satisfied and what is not.
No sprawling forty-tab spreadsheets. No manual highlighting.
You see clear results: what passes, what is missing, and what needs attention.
The repetitive comparison work that drains expert time and creates opportunities for human error is handled by the platform.
Every Medical Device Claim Linked to Its Evidence
Regulatory professionals pay attention to this part.
If you can’t trace a result, you can’t easily defend it.
Every DocuGenius finding links back to the exact page and paragraph in the original document.
Click the result and go directly to the evidence. No more hunting. No more “I think it’s in there somewhere.”
If a notified body or auditor asks where a claim is supported, you have the answer in one place, using the original document rather than a simplified summary.
What About the Difficult Cases?
DocuGenius treats genuine exceptions as exceptions.
When the system encounters ambiguity, conflict, or a situation that should not be resolved automatically, it flags the issue and routes it for expert review.
No guessing. No sweeping difficult cases under a green checkmark.
The issue goes to a human reviewer with the relevant context, so an expert can decide what happens next.
What Could Your Team Do With Those Hours Back?
Medical device claims verification is important work. But not every part of the process requires an expert to spend hours manually comparing documents line by line.
If repetitive checks were handled faster, your regulatory team could spend more time on the decisions that actually require scientific, clinical and regulatory expertise.
That is where DocuGenius fits.
Frequently Asked Questions
What is medical device claims verification?
Medical device claims verification is the process of checking that claims about a device are accurate, consistent with its intended purpose and appropriately supported by evidence across relevant regulatory documentation.
Why do medical device claims need supporting evidence?
Claims about a medical device need to be consistent with the device’s intended purpose, safety and performance and must not mislead users. Under the EU MDR, clinical evaluation and supporting clinical evidence are also connected to the manufacturer’s claims.
Where should medical device claims be checked?
Depending on the device and applicable requirements, claims may need to be reviewed across technical documentation, clinical evaluation, IFU and labeling, risk management, performance evaluation and other supporting evidence.
Can AI verify medical device claims?
AI can assist with repetitive document comparison, evidence retrieval, consistency checks and requirement verification. Ambiguous or consequential cases should remain subject to appropriate expert review.
