For years, The European Union Medical Device Regulation (EU MDR) has quietly reshaped how medical devices are regulated. What’s changed now is who it’s impacting. Marketing teams are suddenly in the spotlight as regulators are finally catching up with the content they create.
Promotional materials, sales decks, websites, and social media posts are now under the same level of scrutiny as product labelling. If a claim is made anywhere about a device, it must be backed by evidence and approved through a formal review process. Vague language, unverified superlatives, or inconsistent messaging are no longer just creative risks—they’re compliance risks as well.
The emphasis on evidence-based claims marks a major shift. Under EU MDR, it’s not enough to call a product 'innovative' or 'best-in-class.' Every medical device claim must align with the device’s intended use and be supported by clinical or technical documentation.
For medical device marketers, evolving regulatory expectations mean promotional review must now be approached with the same level of structure, collaboration, and rigor as product development itself.
Marketing teams used to focus primarily on claims found in product labels and IFUs—but that’s no longer enough. Today, any public-facing statement about a device’s benefits or performance is fair game for regulatory scrutiny.
EU MDR has dramatically broadened the definition of what’s considered 'in scope' for compliance review. While older regulations focused heavily on product labelling and instructions for use, Article 7 of EU MDR extends scrutiny to nearly all commercial and promotional materials.
That includes, but isn’t limited to:
If a piece of content makes a product-related claim—explicit or implied—it’s now subject to the same evidence requirements as regulated labelling. Nothing is exempt based on format or channel.
For marketers, this changes the game. EU MDR compliance demands that every product claim—no matter where it appears—is clear, truthful, and backed by substantiated evidence.
That means:
In short, your promotional content is now regulatory content. It’s incredibly important that marketing teams collaborate more closely with regulatory and legal teams, starting earlier in the content development process. When it comes to EU MDR compliance, 'close enough' is no longer good enough.
Under EU MDR, promotional claims aren’t just marketing copy but regulated statements with legal consequences. If claims are vague, exaggerated, or unsubstantiated, the risk isn’t just a delay in approval—it’s a threat to a product’s presence in the market.
Here’s what’s at stake when promotional materials don’t meet EU MDR standards:
Notified bodies may issue formal warnings or request immediate corrective action if claims are found to be misleading or unsupported.
If a claim is tied to patient risk—or even perceived as such—regulators can demand content be pulled, or in severe cases, halt product distribution.
Repeated violations or high-risk issues can lead to total withdrawal of market authorisation, effectively removing the product from the EU.
Public trust is hard to win and easy to lose. Non-compliance damages brand credibility and can expose your organisation to legal consequences, including civil penalties.
Without proper substantiation, even well-intended claims can trigger major setbacks. To keep this from happening, it’s key that organisations bring the same regulatory rigor to promotional review as they do to product labelling.
One of the core expectations of EU MDR compliance is that every product claim must be substantiated with the right type of evidence—but each claim is different. Understanding how to categorise your medical device claims helps ensure you attach the appropriate proof from the outset, minimising delays during promotional review.
These are claims related to a device’s clinical performance or benefit—how it improves patient outcomes, reduces complications, or performs in real-world settings.
What’s required:
(Example: 'Reduces recovery time by 30%' must be supported by clinical trial results or published studies.)
Technical claims speak to the device’s engineering, construction, functionality, or specifications. These are typically quantifiable and require objective validation.
What’s required:
(Example: 'Delivers pressure with ±5% accuracy' must be backed by formal testing protocols and results.)
These focus on positioning in the market, including user preference, adoption rates, or cost-efficiency. While often less scientific, they still require documented support.
What’s required:
(Example: 'Preferred by 9 out of 10 clinicians' must be tied to verifiable survey methodology or usage data.)
Categorising medical device claims correctly at the start—and pairing each with the right type of evidence—reduces risk, accelerates approval, and strengthens your promotional strategy under EU MDR. It also makes it easier for review teams to spot gaps before regulators do.
To meet EU MDR standards, medical device companies must write claims that are specific, evidence-based, and clearly tied to intended use. That means moving away from vague or marketing-driven language and toward regulatory-aligned messaging that can hold up under scrutiny.
Here’s a look at what strong, compliant claims look like compared to risky, non-compliant alternatives:
Not compliant: 'Best device on the market for infection prevention.'
Why it’s a problem: This is an unsubstantiated superlative. There’s no evidence, no comparison, and no defined metric for 'best.'
Compliant: 'Reduces surgical site infection rates by 45%, as demonstrated in a randomised clinical trial of 500 patients.'
Why it works: It’s specific, tied to quantifiable outcomes, and supported by peer-reviewed evidence.
Not compliant: 'Safe and effective for all patients.'
Why it’s a problem: Overly broad, lacks context, and doesn’t reflect the device’s intended population or indications for use.
Compliant: 'Indicated for the non-invasive measurement of blood oxygen saturation (SpO2) in adult patients during transport.'
Why it works: Clearly defines what the device is for, who it’s for, and under what circumstances.
Not compliant: 'Clinically proven to outperform competitors.'
Why it’s a problem: No mention of which competitors, how performance was measured, or what kind of data backs the claim.
Compliant: 'Demonstrated equivalent performance to the predicate device ABC123 in a 12-week comparative study.'
Why it works: Names the comparator, describes the nature of the study, and stays within the bounds of equivalence.
Strong claims start with strong processes. Here’s how to build a system that supports compliant messaging:
With EU MDR, every word matters. With the right tools and review process, you can help ensure your messaging is both persuasive and fully compliant.
EU MDR compliance doesn’t just hinge on individual claims—it’s about how well your entire review process supports accuracy, consistency, and traceability. These five strategies can help embed compliance into your daily operations and reduce risk across your content pipeline.
Create a centralised library of pre-approved, substantiated medical device claims, each linked to the appropriate clinical, technical, or marketing evidence. This ensures your marketing team starts with compliant language and reduces the chances of introducing unsupported messaging. A centralised claims library also enables your team to route, review, and keep track of local variations or translated claims.
Tag each of your medical device claims as clinical, technical, or marketing during submission and require the matching level of substantiation. This upfront clarity prevents back-and-forth during review and helps ensure every claim passes the scrutiny of regulators and internal reviewers alike.
Manual review processes introduce delays, versioning issues, and audit blind spots. By switching to a digital, automated system, you can:
This reduces errors, accelerates approvals, and makes audits faster and easier.
Engage regulatory and legal teams early in content development to ensure medical device claims are framed appropriately and supported by evidence from day one. This proactive approach saves time, reduces rework, and creates smoother collaboration across departments.
Not all products are equal—some pose more risk than others. It’s important to track claim health across your portfolio to understand:
This visibility helps you prioritise what’s promotion-ready and where to focus your compliance resources.
If your team is still managing medical device claims in spreadsheets, Word documents, or static core claims files, you’re not just working harder—you’re increasing risk and slowing down every downstream review.
Manual claims systems lead to:
In contrast, a structured, digital workflow eliminates the guesswork and gives teams the control they need. A purpose-built claims management module allows you to:
With regulators intensifying their focus on promotional claims, relying on static tools is no longer sustainable. The right digital infrastructure streamlines approvals while making claim validation faster, more accurate, and audit-ready from the start.
Compliance demands aren’t leveling off—they’re accelerating. As EU MDR compliance enforcement deepens, medical device companies must prepare for even tighter expectations in how they manage and approve promotional content.
Here’s what’s on the horizon:
Regulators are no longer focused solely on printed brochures or IFUs. Social media posts, websites, mobile apps, and even email campaigns are under the microscope—if it contains a product claim, it’s in scope.
Blanket substantiation won’t cut it. Every claim—clinical, technical, or marketing—must be directly tied to the right kind of supporting evidence. The days of 'implied validation' are over.
As teams push to launch materials across regions simultaneously, the pressure is on to streamline review without sacrificing compliance. That means coordinated workflows, not scattered emails or siloed spreadsheets.
To meet these challenges, MLR platforms will play a central role. They enable structured, compliant workflows, real-time collaboration, and instant audit readiness—giving teams the speed they need and the oversight regulators expect.
In 2025, GMED (France) certification is a key requirement for placing medical devices on the market in the EU and France, specifically under the Medical Device Regulation (MDR) (EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR) (EU 2017/746). GMED, a designated Notified Body in France, is responsible for assessing the conformity of medical devices to ensure they meet the safety and performance requirements.
ANSM, as a competent authority, is in charge of assessing, designating and monitoring notified bodies in France. To date, only the Group for Assessment of Medical Devices (G-Med) of the National Laboratory for Metrology and Testing in the Medical Health Field (LNE/G-Med) is a notified body in France for MD and IVDMD directives.
EU MDR compliance has become a critical priority for medical device companies. As scrutiny of promotional materials continues to rise, the cost of lagging behind will only grow.
But here’s the good news: compliance doesn’t have to be a burden. With the right systems, tools, and workflows in place, medical device companies can turn regulatory rigor into operational efficiency—and even a competitive advantage.