Are you wondering what you can and can’t say about your medical device? Are you confused about what the regulations actually say?
In reality, you can say more than you might think about your medical device. It depends on which country you’d like to advertise in, your device’s class, and whether you’re speaking to patients or healthcare professionals.
In this article, we’ll cover which regulations you need to follow when talking about your medical device in marketing materials.
Before you say anything, you need a CE or UKCA mark
To be able to speak about your medical device in any marketing materials, your product needs to have a CE or UKCA mark. This includes your device undergoing a conformity assessment to prove it’s both effective and safe for patients.
It’s illegal to advertise or sell your device without a CE or UKCA mark.
Currently, the UK accepts CE-marked medical devices, but this is due to change in July 2025 when all devices in the UK will need a UKCA mark.
If you’re currently working towards your CE or UKCA mark, you can still speak about your treatment area, the goals of your company, and any research you’re doing, but any statements or claims about the device’s indication or intended use would be considered marketing the device.
The regulations you need to know about
As marketers, we don’t need to understand all the details of the EU MDR. However, it will make marketing your device easier if you understand what the regulations allow and don’t allow you to do.
For medical devices, the main regulation to follow is the EU MDR within Europe and the medical devices Regulation for the UK. The EU MDR is a European regulation that was published in May 2017 to increase the safety and performance of Medical Devices.
The EU MDR is an umbrella guideline you have to follow; however, you still need to follow local guidelines. Each country in the EU and the UK will have its own way of implementing the EU MDR regulation. This means some countries will be more stringent than others, adding additional requirements that you must meet. We’ll go into local guidelines more later in this article.
For both the EU MDR and local guidelines, it’s important to understand a few key terms.
Intended purpose
The intended purpose outlines a device’s medical use, information about its mode of action, and the patients and medical conditions it treats.
Your intended purpose will explain what your device is, the patient population it can treat, and how it can be used. It’s important to thoroughly know and understand your intended purpose, as it affects what you can and can’t say about your device.
IFUs
IFUs (Instructions for Use) are documents that provide step-by-step instructions on how to use your medical device safely. They ensure patients and healthcare providers are using your device effectively and safely.
Device classes
Medical Devices are categorised based on their risk, and you need to know where your device sits, as it will affect what you can and can’t say in different regions. The classes are:
- Class I: A medical device with low risk. For example, wheelchairs.
- Class IIa: A medical device with low to medium risk. For example, hearing aids, catheters.
- Class IIb: A medical device with medium to high risk. For example, ventilators.
- Class III: A medical device with the highest possible risk. For example, pacemakers.
Look for some guidance when it comes to the rules in medical device?
Why do these regulations matter?
Understanding your intended purpose is essential, as the only advertising requirement for medical devices under the EU MDR is:
“In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance.”
Your intended purpose is the foundation of what you can and can’t say about your Medical Device. If a claim, feature, or benefit is not listed in your intended purpose, you are not allowed to advertise it in any capacity.
The main takeaway is that if it misleads your audience about your device’s intended purpose, you can’t say it!
The EU MDR also states that this applies to:
- Logos
- Images
- Names
- Trademarks
It’s important that all marketing materials, including your website and social media, clearly talk about what your device does and in no way confuse your audience about the device’s intended purpose.
Discussing the benefits of your device
Your intended purpose will include a list of benefit-led claims; these claims will be supported by evidence from clinical trials. For example, a pacemaker’s intended purpose could include:
“The pacemaker sends electrical impulses to the heart muscle, which stimulates the heart to beat at a normal rate. This helps to improve blood flow and oxygenation throughout the body and can prevent symptoms such as fainting, shortness of breath, and fatigue that can be caused by a slow or irregular heartbeat.”
Based on the example above, you would be able to discuss the benefits of preventing shortness of breath in any marketing materials.
However, the example above says “helps to improve blood flow,” so you would not be able to say “always improves blood flow,” as this would be misleading because it may not achieve this.
Complying with local guidelines
The biggest difference among the countries is whether you can talk directly to patients about your device.
In Italy, only devices that do not require a prescription or HCP use can be advertised to patients, while in France, only devices in classes 1-2b can be, with additional requirements.
We’ve created a local guidelines document that details what you can and can’t talk about.