The European Union has the second-largest medical devices (MD) industry 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 medical devices logistics importing, selling, and marketing 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.
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.
Comparative Advertising
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? | Comparative Advertising | Online advertising | Disease limitation | |
| Germany | ✔ | ✔ | ✔ | ✖ | Yes |
| France | ✔ | ✔ | ✔ | ✔ | None |
| UK | ✔ | ✔ | ✔ | ✖ | None |
| Italy | ✔ | ✔ | ✔ | ✔ | Yes |
| Spain | ✔ | ✔ | ✔ | ✔ | Yes |
| Switzerland | ✖ | ✔ | ✔ | ✔ | None |
| Netherlands | ✔ | ✔ | ✔ | ✔ | Yes |
| Belgium | ✔ | ✔ | ✔ | ✔ | Yes |
| Sweden | ✔ | ✔ | ✔ | ✔ | Yes |
| Austria | ✔ | ✔ | ✖ | ✔ | Yes |
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.
More Information? GrowthImports
We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.
Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards.
With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
GrowthImports BV
Boompjes 5 | 7607 HE Almelo
The Netherlands