23 May 23
Are you wondering what you can and can’t say about your Medical Device in 2023? Are you confused about what the regulations actually say?
In reality, you can say more than you think about your Medical Device. It depends on what 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.
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.
As marketers, we don’t need to understand the ins and out of the whole 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 their own way of implementing the EU MDR regulation. This will mean 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.
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 (Instructions for Use) is a document that provides step-by-step instructions on how to use your Medical Device safely. It ensures patients and healthcare providers are using your device effectively and safely.
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!
It’s important that all marketing materials, including your website and social media, clearly talk about what your device does and in no way confuses your audience about the device’s intended purpose.
Your intended purpose will have 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, during any marketing materials, you would be able to discuss the benefits of preventing shortness of breath.
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.
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 – with additional requirements.
We’ve created a local guidelines document that details what you and can’t talk about.
Podymos is a healthcare marketing agency, specialising in downstream Medical Device marketing.
We’re more expensive than non-specialised agencies and freelance teams because we only work in the Medical Device space so we have specialist knowledge and experience that other agencies may not be able to offer you.
If you want high-quality, compliant campaigns that help achieve your business goals, we’d love to hear from you. Simply leave us your contact details below and we’ll get back to you very soon for a no-obligation chat.
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