Following a delayed transition, the new European Medical Device Regulation (EU MDR) is finally here after 4 years of industry, regulator and Notified Body preparation.
You’ve likely heard your regulatory, clinical, and post-market surveillance teams discussing these requirements, but how does it impact medical device advertising and promotion in Europe? And how does it affect you as a medical device marketer?
The EU MDR applies to all 27 EU member countries, but does it override country regulations? The simple answer is not in all instances; whilst from a technical perspective, the regulation is directly and uniformly applicable, you will still need to also comply with each Member State’s regulations and guidelines in addition to the EU MDR when advertising and promoting your device in the EU.
What is the EU MDR?
The Europe-wide MDR came into force on the 26th of May 2021, with the primary aim to ensure the quality, safety and performance of medical devices through a robust, state-of-the-art regulatory framework.
It improves on the previous Medical Device Directive by bringing requirements into line with new technically demanding products and patient demands, including particularly more demanding ongoing clinical data requirements for a device’s intended purpose.
What is the 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.
Put simply it’s the information your company provides to the regulatory authorities to receive its CE mark.
Any uses identified in your intended purpose must be backed up with clinical and safety evidence, but features or specifications of the device are not included. This means in your marketing, you can only reference the uses mentioned in your intended purpose, but you can reference any device features, if this doesn’t mislead your audience about your device’s intended use.
As the EU MDR has more stringent clinical requirements than the previous Medical Device Directive, some devices may already have streamlined their intended use if unable to provide supporting clinical evidence. It’s vital you are aware of the current intended purpose of your device to deliver effective and compliant marketing.
How does the EU MDR affect existing country regulations?
The EU MDR represents the unified European regulatory requirements for medical devices that must be followed throughout Europe to secure and maintain your CE mark. Unlike the previous Medical Device Directive, the MDR is directly applicable, without exception, in all European Member States.
The MDR however, only details the quality, safety and performance requirements for products, allowing for local regulations or guidelines to cover aspects such as advertising and promotion. Before meeting the needs of any individual country’s regulations, you need to ensure you’re meeting the EU MDR.
What does the EU MDR say about medical device advertising and promotion?
In short, not a considerable amount, but still more than its predecessor, the EU Medical Device Directive.
Under Article 7 of the MDR, you’re advertising, and promotion literature must be in line with the intended purpose of your medical device as laid out in your technical file and ‘Instructions for Use’ (IFU).
Why is your medical device’s intended purpose so important when complying with the EU MDR?
A device’s intended purpose must be adhered to throughout its lifetime, as it is demonstrated and proven in the clinical evidence, safety data and risk reports contained within the CE marking ‘Technical File’.
All communications with patients or healthcare professionals have to be based on these technical details, in order to maintain the product’s CE mark.
Whilst as a marketeer you’ll never need to write an intended purpose, knowing and understanding it will become central to everything you do with your device.
How do local country regulations affect how I advertise a medical device?
Outside the EU MDR, each country has its own advertising and promotion rules, and most will have specific guidelines for medical devices.
A common theme in local guidelines is the importance of advertising and promotional materials is firstly not being misleading, and secondly that it reflects the intended purpose of the device.
These principles include all pictures, logos, text, names, and trademarks. Additionally, countries may specify what can and cannot be said when comparing one device with another.
HCP vs patient medical device advertising
Under the EU MDR, there is no distinction between marketing to HCPs or patients; therefore, all HCP marketing must meet the same EU MDR requirements as a minimum.
Differences between Member States do exist, however. For example, while Germany does not provide additional guidelines for HCP marketing, the remaining Member States address the need to provide clear, unbiased information to allow the HCP to choose the most fit for purpose device. Indeed, in Spain, the requirements are greater still, as all information needs to be provided by a trained professional.
Marketing directly to the patient often comes with more limitations and restrictions, with some countries such as France, Spain and Italy not allowing advertising and promotion for specific device types.
France, for example, has the strictest rules forbidding marketing to a patient for any device that has a risk classification of IIb or higher. At the same time, Spain only allows the marketing of devices not funded by its national health service.
At the bottom of this article, we have created an EU MDR and local country medical device advertising guidelines table of what is allowed in major European countries.
Can I advertise a medical device on social media in the EU?
There has been heightened concern in the medical device community about what is permissible in digital marketing.
The EU MDR doesn’t address online marketing requirements but does require that medical device websites be seen as labels. As such, the rules for traditional marketing also apply to social media and digital marketing.
In summary, this means that so long as your post, article, or content aligns with your intended purpose, is supported by the correct clinical data, and your content is not misleading in any posts, images or trademarks you will comply with the EU MDR.
In specific Member States, you will need to meet local advertising and promotion requirements for all online advertisements: for example, in the Netherlands, as in many other territories, you will need to consider language requirements. As the Internet is available to everyone, online advertisements will need to be aligned with patient marketing requirements.
This is not always the case however, as in France and Denmark, Healthcare Professional marketing can only be undertaken if the specific sections are password-protected, whereas in Italy, the same information can be provided online with disclaimers.
Concluding thoughts
Medical devices, in most cases, can be marketed to patients and HCPs provided the EU MDR and country guidelines are followed.
Ensure you have a firm understanding of your device’s intended purpose and relevant country guidelines, and you are not misleading your audience in any way, including through text, pictures, logos or trademarks.
To help with individual country guidelines, we have created the following guide highlighting the differences in marketing medical devices for both HCPs and patients throughout Europe.