Inconsistent labeling, inadequate IFUs, claims lacking supporting evidence, and discrepancies between regulatory content pose potential risks that might come up in the course of submission, audit, or market expansion.
Elexes performs a comprehensive medical device labeling and IFU compliance review to identify regulatory gaps across labels, IFUs, packaging content, and claims before they become costly issues.
Trusted by teams preparing for FDA submissions, EU MDR compliance activities, Design and labeling updates, Market expansion projects and Internal and external audits
Device Types Supported are Medical Devices, Software as a Medical Device (SaMD), In Vitro Diagnostics (IVDs) and Combination Products.
Expert Involvement
Every project is reviewed by experienced Regulatory Affairs and Quality Assurance professionals.
Your device labeling and IFU may appear complete, yet still contain regulatory gaps that trigger questions during review or inspection.
These issues often remain unnoticed until identified by the respective authorities, notified bodies, auditors, or clients themselves.
Some issues include:
⦿ Missing mandatory label elements
⦿ IFU content not aligned with intended use
⦿ Unsupported performance or marketing claims
⦿ Missing warnings, precautions, or contraindications
⦿ FDA and EU MDR inconsistencies
⦿ Outdated labeling following design changes
⦿ Incomplete symbol usage and labeling standards alignment
Small omissions can lead to significant remediation effort later.
This service is designed for:
⦿ Regulatory affairs managers preparing a submission
⦿ Quality teams performing labeling or submission-readiness checks
⦿ Product marketing teams making claims on the label
⦿ Medical device startups with their first submission
⦿ Manufacturers entering new markets
⦿ Teams revising labeling after changes to design
⦿ Organizations responding to regulatory authorities' feedback
⦿ Companies preparing for notified body or FDA inspection
To avoid confusion, this service is not:
⦿ A graphic design service
⦿ Artwork creation or label formatting
⦿ Translation services
⦿ A proofreading-only review
⦿ Submission writing services
⦿ IFU usability testing studies
Instead, this service focuses on identifying regulatory compliance risks across labeling, IFUs, and claims.
A medical device label requirements review helps identify problems before they affect submission timelines or market access activities.
Elexes helps organizations:
⦿ Align labeling with applicable regulations
⦿ Verify claim substantiation using appropriate data
⦿ Increase IFU completeness and accuracy
⦿ Avoid unnecessary regulatory queries
⦿ Improve audit preparedness
⦿ Ensure cross-market regulatory compliance
⦿ Ensure label compliance prior to filing
Our team reviews:
⦿ Product labels
⦿ Device packaging labels
⦿ Carton labels
⦿ UDI-related content
⦿ Symbols and markings
⦿ Manufacturer information
Label review is done by assessing how well labeling complies with regulatory guidelines for medical devices.
We evaluate:
⦿ Intended use alignment
⦿ Indications and contraindications
⦿ Warnings and precautions
⦿ User instructions
⦿ Safety information
⦿ Risk communication content
Claims are assessed against:
⦿ Regulatory clearances
⦿ Clinical evidence
⦿ Performance data
⦿ Product specifications
⦿ Approved indications
We compare labeling requirements against:
⦿ FDA expectations
⦿ EU MDR Annex I requirements
⦿ Applicable international labeling standards
We review:
⦿ Labels
⦿ IFUs
⦿ Packaging content
⦿ Marketing-related claims
Documents are assessed against applicable regulations and standards.
We identify:
⦿ Missing required elements
⦿ Claims-evidence mismatches
⦿ Regulatory compliance gaps
⦿ Cross-document inconsistencies
⦿ Market-specific deficiencies
Our team provides:
⦿ Labeling structure recommendations
⦿ Claims positioning guidance
⦿ Risk reduction strategies
⦿ Cross-market alignment recommendations
You receive:
⦿ Annotated review comments
⦿ Regulatory requirement mapping
⦿ Risk observations
⦿ Corrective action recommendations
Where needed, we provide:
⦿ Label content recommendations
⦿ IFU restructuring guidance
⦿ Claims correction recommendations
Reviews are aligned with:
⦿ FDA labeling expectations
⦿ EU MDR Annex I requirements
⦿ ISO 20417 principles
⦿ ISO 15223-1 symbol requirements
You will receive:
⦿ Labeling & IFU Risk Assessment Report
⦿ Claims Substantiation Review
⦿ Annotated Labeling and IFU Comments
⦿ FDA / EU MDR Gap Assessment
⦿ Symbol and UDI Review Summary
⦿ Prioritized Corrective Action Roadmap
Failure to address labeling issues may result in:
⦿ Submission deficiencies
⦿ Additional review cycles
⦿ Regulatory questions regarding intended use
⦿ Audit findings under ISO 13485 systems
⦿ Delayed market access
⦿ Costly remediation projects
⦿ Labeling corrections after launch
⦿ Increased regulatory scrutiny
Addressing these issues early is significantly less expensive than correcting them after submission.
Experience supporting compliance activities across FDA, EU MDR, and international regulatory frameworks.
Support across: Class I, II, and III devices | IVDs | SaMD | Combination products
Recommendations are practical and aligned with real-world regulatory expectations.
Projects are reviewed with both regulatory and quality system expectations in mind.
Device Type: Class II Diagnostic Device
Challenge: The company had issues related to incomplete IFUs and inconsistent claims for the device in multiple documents.
Work Performed
⦿ Labeling review
⦿ IFU gap analysis
⦿ Claims assessment
⦿ Regulatory mapping
⦿ Corrective action recommendations
Result: The company identified labeling and IFU risks before submission and prioritized corrective actions.
Medical Device Labeling & IFU Submission Readiness Checklist
Labeling, IFUs, packaging content, and claims should work together to support regulatory compliance.
Elexes helps manufacturers identify compliance risks early and prioritize corrective actions before submissions, audits, or market expansion activities.
⦿ Send your label and IFU documents to us
⦿ Obtain a comprehensive risk analysis
⦿ Get clear corrective action recommendations
⦿ Improve labeling readiness before submission
Medical device labeling must provide key information for safe use, including intended use, warnings, manufacturer details, and other required regulatory content.
An IFU typically includes indications, contraindications, warnings, precautions, and instructions for safe and effective device use.
Yes. FDA and EU MDR have different requirements, although both require clear, accurate, and compliant labeling.
Not always. Some low-risk devices may not require a full IFU if users can operate them safely through labeling alone.
Yes, but all claims should be evidence-based and aligned with the device’s intended use, indications, labeling, and supporting data.
Non-compliant labeling can lead to regulatory questions, submission delays, audit findings, or corrective actions.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
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MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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