Medical device promotional claims must align with intended use, approved labeling, available evidence, and market-specific regulatory expectations. Elexes reviews advertising and promotional materials to identify unsupported, overstated, or high-risk claims before public release.
Marketing Claims Are Often Published Before They Are Properly Validated
Marketing teams work under tight launch deadlines. New brochures, website content, advertisements, and campaign materials are often created faster than claims can be reviewed against evidence and regulatory requirements.
This is a common challenge for launch teams.
Organizations often run into situations with:
⦿ Unsupported performance claims
⦿ Overstated product benefits
⦿ Inconsistent messaging versus approved labeling
⦿ Promotional content that exceeds approved indications
⦿ Regulatory concerns about claim substantiation
And here’s the bottom line:
In many launch environments, claim creation moves faster than regulatory and evidence review.
Without undergoing a rigorous medical device advertising compliance review, companies could be introducing compliance risks without realizing it.
This service is designed for:
⦿ Regulatory Affairs teams reviewing promotional claims
⦿ Marketing teams preparing product campaigns
⦿ Product managers aligning messaging with intended use and evidence
⦿ Medical device manufacturers preparing for launch
⦿ SaMD, IVD, and hardware device companies updating promotional content
⦿ Companies expanding claims across FDA, EU MDR, TGA, Health Canada, or global markets
⦿ Teams responding to internal, customer, distributor, or regulator concerns about claims
To avoid confusion, this service does not include:
⦿ Clinical evidence generation or clinical study execution
⦿ Regulatory submission preparation or dossier development
⦿ Branding, creative design, or marketing campaign development
⦿ Legal advertising reviews by legal counsel
⦿ Simple checklist reviews without claim validation and risk assessment
Our focus is on regulatory and evidence-based review of medical device advertising and promotional claims.
Medical device promotional claims have to be truthful, substantiated, and consistent with approved indications for use.
Elexes helps medical device manufacturers assess promotional claims against regulatory expectations, approved labeling, and available evidence.
Outcome
Companies receive a structured view of which claims are supported, which require modification, and which may create elevated compliance risk before launch or market expansion.
Benefits include:
⦿ Better alignment between claims, intended use, labeling, and evidence
⦿ Clearer claim substantiation expectations
⦿ Reduced risk of unsupported or overstated promotional content
⦿ Improved coordination between Regulatory, Clinical, Product, and Marketing teams
⦿ Stronger internal review control before launch
We review public-facing promotional content, including:
⦿ Websites
⦿ Product landing pages
⦿ Brochures
⦿ Sales/marketing material
⦿ Digital advertisements/Campaign messaging
⦿ Product videos and promotional content
Our experts identify:
⦿ Unsubstantiated efficacy claims
⦿ Inflated performance claims
⦿ Claims made without comparative evidence
⦿ Claims exceeding approved indications
⦿ Claims that could lead to regulatory problems
We determine the feasibility of substantiating any claims and the limits of promotion.
This helps teams understand:
⦿ What claims can be used?
⦿ What claims require modification?
⦿ What claims require additional support?
⦿ Which claims create elevated compliance risk?
We provide detailed, claim-specific feedback directly on promotional materials, which includes:
⦿ Claim-specific observations
⦿ Evidence gaps
⦿ Observations on compliance issues
⦿ Revisions recommended
⦿ Requirements for substantiation
For any revision needs, we support marketing and regulatory teams by reviewing revised content and validating corrections before publishing.
In case there are any questions about claims raised by regulators or internal reviewers, we assist in responding to them with supporting evidence and rationale.
Deliverables depend on individual project requirements, but generally include the following:
These services are often viewed as interchangeable, but they address different aspects of promotional compliance.
Focuses on:
⦿ Websites
⦿ Advertisements
⦿ Brochures
⦿ Campaign messaging
⦿ Public-facing promotional content
Goal: Make sure the claims are compliant before publishing.
Focuses on:
⦿ Sales presentations
⦿ Distributor Communications
⦿ Sales FAQs
⦿ Field Communication
⦿ Message Control
Goal: Ensure field teams communicate within approved boundaries.
Regulators, auditors, competitors, customers, and internal reviewers may scrutinize promotional claims.
Promotions that do not match the evidence or approved labeling may create unnecessary compliance risks.
Outcome may include:
⦿ Observations regarding regulations
⦿ Promotional content correction requests
⦿ Claims-related warning communications
⦿ Audit findings
⦿ Customer complaints
⦿ Delays in commercialization activities
⦿ Reputational damage
Organizations choose Elexes because of our ability to connect regulatory requirements, clinical evidence, and commercial messaging.
Our Capabilities Include:
⦿ Experience with FDA promotional requirements
⦿ Expertise supporting EU MDR compliance
⦿ Knowledge of TGA and Health Canada expectations
⦿ Experience in SaMD, IVD, and hardware medical device development
⦿ Strong claim substantiation expertise
⦿ Senior Regulatory Affairs involvement
⦿ Practical understanding of real-world marketing materials
⦿ Risk-based review methodology
Type of Device: Class II Medical Device
Challenge: Claims of performance made through marketing copy did not have consistent evidence backing them.
Scope of Review
⦿ Advertising compliance review
⦿ Mapping of claims substantiation
⦿ Promotion risk assessment
⦿ Marketing copy analysis & recommendations
Outcome: Elexes identified unsupported and inconsistent promotional claims, mapped claims to available evidence, and helped the team revise launch materials to better align with intended use, labeling, and substantiation expectations.
12-Point Medical Device Advertising Compliance Checklist
Your marketing claims need to be validated prior to regulatory review, audit, customer or competitive scrutiny.
Your promotions must be supported by facts, be compliant, and align with approved information about the product.
⦿ Material Review Kickoff
⦿ Claims Validation
⦿ Actionable Compliance Feedback
⦿ Final Medical Device Promotional Review Summary
It is the process of ensuring promotional materials and marketing claims comply with applicable medical advertising regulations and are supported by evidence.
Yes. Every claim should be supported by appropriate clinical, technical, or scientific evidence.
Yes. We review websites, landing pages, advertisements, brochures, and other promotional materials.
Unsupported claims, overstated benefits, implied claims, comparative claims without evidence, and inconsistent messaging.
Yes. Conducting the review before public release helps reduce avoidable claims-related compliance risk.
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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