Medico Digital Insights

The marketer’s guide to the EU MDR and advertising and promotion of medical devices – 2023 update

Compliance

Read time

7 min

When

1st March 2023

Who

Written by Jessica Engler

About

Advertising
Regulations

As a digital marketer in the healthcare sector, you have the tricky task of staying abreast of the latest digital trends, whilst at the same time ensuring that your marketing is compliant with all the relevant regulatory guidelines. That includes those regulations that apply to the protection of consumer privacy rights, such as GDPR, and those that govern the advertising and promotion of medicines and medical devices. In this post, we’re going to take a look at the European Union Medical Device Regulation (EU MDR), a new set of laws that govern the production, manufacture and distribution of medical devices in EU member states. 

The EU MDR came into law on May 26, 2021, and MedTech companies must comply with the new regulations if they want to retain their CE mark and sell their medical devices in Europe. The EU MDR governs the entire lifecycle of a medical device, including sales, distribution and promotion. It’s your role as a marketer to ensure that your digital marketing complies with this regulation. 

Why is the EU MDR so important?

There are over 500,000 types of medical devices and In Vitro Diagnostic medical devices (IVDs), including plasters, X-ray machines, pacemakers, healthcare software apps, pregnancy tests and diabetic blood sugar monitoring devices. The EU MDR replaces the outdated EU Medical Device Directive (MDD) from 1992. Whereas the old MDD focused on how companies got their products to market by obtaining their CE mark, the new EU MDR takes a more holistic look at the entire product lifecycle of a medical device. 

The strategic and logistic importance of the new EU MDR cannot be overstated for MedTech companies, which must ensure that all new and existing products are compliant with the new regulations no later than May 25, 2024.

Furthermore, the EU MDR has mandated the inclusion of many products that were not previously covered by the MDD. Newly classified medical devices include products or substances used in the body either cosmetically or surgically, including:

  • Contact lenses and other products put in the eye (eye drops)
  • Facial fillers
  • Breast implants.

For those companies subjected to medical device compliance for the first time, there is likely to be a steep learning curve.

It’s also important to first note that although compliance with the EU MDR is binding, the rules and regulations do not supersede an individual country’s national regulations on the promotion and advertising of medical devices. Rather, you must follow both the EU MDR and the individual country regulations when marketing a device in an EU member state. As you might have guessed, the UK is not covered by the EU MDR. The rather complicated landscape of medical device advertising is set out in the Blue Guide of the Medicines & Healthcare products Regulatory Agency (MHRA) and more specific advertising guidelines can be found in Section 12 of the Advertising Standards Association (ASA)

So what do you as a marketer need to be aware of?

What is a device’s intended purpose and why is it so important?

Whether you are marketing a medical device directly to consumers 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 defines the intended purpose as: 

“…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:

  1. ascribing functions and properties to the device which the device does not have;
  2. creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
  3. 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;
  4. 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: 

  1. You must always refer to the device’s intended purpose when crafting your marketing messaging. 
  2. 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. 

Frequently asked questions about the promotion and sales of medical devices

As previously mentioned, the EU MDR takes a very headline view of marketing and promotion of medical devices. Compliance focuses on adhering to the device’s intended purpose in your messaging but does not reference any specific guidance about digital marketing, social media promotion or any other paid advertising. You must consult a country’s individual regulations on advertising and promotion of MedTech devices to find out these specifics. Here are some common questions and broad guidance about advertising medical devices in the EU.   

Are there any differences between marketing directly to patients or to HCPs? 

The EU MDR does not make any distinction in the promotion of medical devices for patients or end consumers versus HCPs. However, at the individual country level, stricter rules often apply when marketing directly to patients. It’s common that ads should not be aimed at children and that adverts must be marked as such. Many countries further stipulate that devices only authorised for use by HCPs cannot be advertised directly to end-users and must be hosted on password-protected sites or places otherwise inaccessible to potential patients.

Can you market a medical device on social media?

Again, there is no specific mention of specific digital channels in the EU MDR. So yes, you can advertise a medical device on social media as long as it adheres to the device’s intended purpose. It is critical that you understand your target countries’ rules and regulations, however. 

In some countries, social media promotion is broadly permitted; in others, it is permitted but only with restricted social features like moderation of comments and deactivation of likes. Some countries such as Italy and Spain, require that you get approval from official health authorities or internet oversight bodies prior to posting.

In addition to these country-specific regulations, there are also restrictions put into place by some social platforms. LinkedIn’s advertising policy, for example, doesn’t allow ads for medical devices for home or consumer use. 

Can you do comparative medical device advertising?

The EU MDR mandates that advertisements cannot be misleading in any way. So although you can compare devices in your digital marketing, the intended purposes of the compared devices need to be similar. Furthermore, the ad must not discredit competitors or create any confusion about competitor trademarks or trade names. At the individual country level, comparative advertising is broadly permitted but you should carefully consult individual guidelines to ensure your chosen brands are equivalent in terms of price, clinical data, market share, etc.  

Compliance can be challenging – we’re here to help

Although the basics of the EU MDR are clear, adhering to individual country regulations and individual platform guidelines for your campaigns can quickly get complicated, especially if you want to target multiple locations. At the highest level of EU MDR compliance, you must be aware of your device’s intended purpose and make sure your campaigns are not misleading in any way, whether that’s through the use of text, image, trademarks or supporting data/graphics. Whilst this is a good blueprint for any marketing campaign, you’ll also need to consult the specific rules and regulations for each of your targeted geographical regions. That’s where the help of a specialist healthcare marketing agency can be particularly helpful. Medico has proven experience working with MedTech companies to design compliant yet impactful digital marketing campaigns with measurable results. We’d love to hear from you. 

How can Medico transform your healthcare business?

I need help with
cloud
Deep understanding of the healthcare market
data
Access to vast amount of data
squared_man
Detailed patient personas

FREE guide: The 6 most common healthcare marketing mistakes and how to avoid them

Medico DigitalExcellentMedico Digital4.9 Based on 51 reviews fromSee all reviewsMaria Zaleska ★★★★★ Medico have been a pleasure to work with. Their digital expertise and sector knowledge enable them to be agile and complete projects efficiently and on a budget, in a way that I haven’t experienced from other med-comm agencies. They provide great advice and strategy that I would highly recommend if you’re looking for a healthcare marketing agency that can truly deliver on your digital objectives. Maria@NevroResponse from the ownerThanks Maria, this means a lot! It was a fantastic project to work on, hugely strengthened by your in-depth knowledge and ability to communicate and help us understand the HCP and patient journey for this truly innovative treatment. Really looking forward to continuing our relationship. Wayne Allison ★★★★★ The team at Medico have always provided top quality digital support, often going above and beyond for our UK team.Response from the ownerThanks so much for your review Wayne, much appreciated! Ilaria DE GIOVANNI ★★★★★ The team at Medico have been brilliant at working with our MLR team to get content approved, going above and beyond with sourcing and research. As well as the medical accuracy, the content is always really high-quality and readily optimised. Would definitely recommend them!Jim miller ★★★★★ Medico have been an excellent company to work with. They are always quick to respond to requests, understand difficult issues and ensure that the outcome is what we've been looking for.Ben Eddy ★★★★★ We have used medico Digital for my personal website, they have provided an excellent service, particularly when it comes to editing and refining the site so make it work and function properly. They have an attention detail and its been excellent working with them. I have used jack Lewis to build my site and he has created an excellent and professional looking site. Many thanks Medico Digital.Liz Marshall ★★★★★ Hi, Medico digital built our website and we are delighted with it, nothing was too much trouble and the after sales is also great we still have few areas to add which we as a company are working on ready for Jack to complete the project. I would recommend Medico DigitalMazin KC (KC Mazin) ★★★★★ Had a great collaboration with Medico Digital. Efficiently scaled the business and achieved the goal.Response from the ownerThanks Mazin, it was a pleasure working with you and the VPS team. Adam Harding ★★★★★ Fantastic team who deliver a great service and product. Very responsive. Overall a great experience.Digitaldrop Solutions ★★★★★ Best Digital Marketing services at affordable prices range and Team Response was Very GoodJosephine Trotter ★★★★★ Medico Digital are a fabulous agency with an impeccable standard of service. The team are friendly, professional, quick to respond, and solution focused. They oversee both our websites, our SEO strategy, and our PPP objectives. Most recently they managed the migration of our websites to WordPress and this project crossed the line on-time and without a single hitch, we felt we were in safe hands at all times. We are delighted to be working with them and would highly recommend them to anyone who strives for the best!Joshua Harwood ★★★★★ Jack and the team were excellent throughout. Medico Digital were more expensive than I originally intended for my website but I really don't regret paying extra. They made me a great website, were responsive throughout the process and guided me through it. Since launch they have continued to support me to figure out how the whole thing works. I could have used a little more guidance on what I need to do after launch (e.g. maintenance, google analytics etc) as certain things were set up without telling me and I did not know about it, but that is not enough of a concern to warrant losing a star and every time I ask they come back and help very quickly. Overall very good service, I would recommend.Jonathan Gill ★★★★★ The whole team have been exceptional in developing and managing my private practice website which significantly increased the number of patients that I see.ENT Sheffield ★★★★★ Beth Soanes and her team are a pleasure to work with and great help to my practice.shyam menon ★★★★★ It was a pleasure working with Jack. His advice and expertise enabled a very smooth and professional experience.js_loader