The European Union has the second largest medical device market share in the world, worth €140 billion, which corresponds to 27.6% globally. The United States takes the top spot with 41.6%.
Every step of importing, selling, and marketing medical devices in the EU involves stringent regulations. The industry was once governed by the Medical Device Directive (MDD), eventually amended by the current Medical Devices Regulation (MDR).
Advertising of Medical Devices
The MDD was established in 1993, meant to reconcile all regulations within Europe. In 2017, the MDR replaced it and expanded on its provisions.
According to the MDD, only medical devices that carry the CE mark can be advertised or promoted in the EU. The directive also made it clear that only medical devices that complied with requirements can be advertised.
Advertising should be in accordance with its intended purpose “according to the data supplied by the manufacturer on the labelling, in the instructions, and/or in promotional materials.”
The MDR expanded this to include “as specified by the manufacturer in the clinical evaluation.” This means that if a marketing team makes a claim about a medical device, it should be backed by clinical data. Advertising should always center on the medical device’s intended purpose.
Each of the 27 countries under the EU has its own laws regarding advertising. However, there is a universal sentiment that marketing initiatives and promotional materials should not be misleading.
The intended purpose of your medical device
Whether you are marketing a medical device directly to patients or those only intended for HCP use, the most important thing you need to be aware of is the device’s intended purpose. Article 2 (12) of the EU MDR:
“…the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation” (emphasis added).
The intended purpose, as defined by an appropriate medical professional, must be adhered to throughout its product lifecycle.
For marketers, the intended purpose is the foundation of what you can and cannot say in your sales and marketing material. The EU MDR doesn’t lay out any specifics for sales and promotion – you’ll have to look to the individual country laws of your targeted demographic for that – but it does touch upon the critical importance of not misleading the patient or HCP in Article 7:
“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 by:
- ascribing functions and properties to the device which the device does not have;
- creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
- failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
- suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out”.
So, the overarching takeaways for digital marketers to note from the EU MDR centre around the following two principles:
- You must always refer to the device’s intended purpose when crafting your marketing messaging.
- You must ensure that your sales and promotional material do not mislead the end-user in any way through the use of text, images, charts, data or trademarks.
Newly Classified Medical Devices
The MDR also expanded what would be included in the regulations. The following products are now regulated under the MDR:
- Products put in the eyes, like contact lenses and eye drops
- Breast implants
- Facial fillers
Advertising to Patients & HCPs
The MDR does not make distinctions between advertising to healthcare professionals and patients.
Medical device manufacturers must consider local legislation as some may be more particular about advertising to patients.
While the MDR didn’t specifically touch on this, it clearly prohibits misleading information. So, if the manufacturer intends to launch comparative advertising, products from different brands must be tested using identical parameters.
Advertising Guidelines in EU Countries
While the United Kingdom is no longer part of the EU, it is still under the transition period, which means that the MDR is still in effect until 2023. For that purpose, the UK is part of this list, along with the nine other EU countries that make up the biggest medical device markets in the country.
Here are some of the important advertising regulations per country:
|Can advertise directly to patients?||Can advertise directly to HCPs?||
Knowledge of Advertising Regulations
The medical devices market in Europe is a profitable industry. However, medical device manufacturers should be aware of the advertising rules mandated by the Medical Device Regulations (MDR).
While the MDR is a widely recognized law across all EU nations, manufacturers must also consider local regulations in the Member State they are targeting. Some countries have their own policies about advertising medical devices.
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