Key Rules for Marketing Medical Devices

Marketing medical devices can be a challenge. The Advertising Standards Authority (ASA) and Committee of Advertising Practice (CAP) shape the rules for advertising in the UK, including what you can and cannot say about medical devices. Medicinal or medical assertions and indications can be made for a properly certified medical device. A medical or medicinal assertion suggests that a product or its components can be utilised for diagnosing medical conditions, or for treating or preventing diseases, including injuries, ailments, or adverse conditions, whether physical or mental, in humans.

Responsible Advertising Across Different Channels

Print and broadcast:  When you advertise medical devices, you need to follow strict rules to make sure your communication is responsible. Your ads must be truthful and not misleading, and you should avoid making over the top claims. By presenting your medical devices in a balanced way, you can encourage people to use them without overstating what they can do. The benefits you talk about should match what the average person can expect to gain from using your product.

It is important to have evidence for all the claims you make in your advertising (Rule 12.1) .  If you have imported (or are going through the process of importing) your medical device in the UK, then you should already have this proof.  However, the Medical Devices Directive and UK advertising law are separate systems - just because you've got certification under the Directive doesn't mean you meet UK advertising law requirements.

Digital and social media considerations: In the digital world, you do need to be careful. Your company has an influence on all branded online content, including messages from employees or third-party representatives acting on your behalf. However, you're not responsible for third party content or user-generated content (UGC) on independent websites or social media platforms. But be careful with paid Ads, affiliated and influencer activities!

Direct-to-consumer marketing: When you market straight to consumers (DTC), you need to use language that's easy for customers to understand and fits your target audience. Show any information about risks without distractions and put it where people can see it.  When you advertise online, remember that you can't guarantee healthcare professionals are seeing your content.

CAP Code 12

The CAP Code is extensive but here are a few things you need to be aware of:

•  You need to have the evidence must back up claims
  You can’t discourage people from getting care for health issues that require a doctor's oversight.  However, you can share accurate and responsible general information about conditions.
  

•  If your treatment is physically invasive, you may be asked to provide full details of who supervises or administers the treatment by the ASA or the media.  You should also advise consumers to seek independent medical advice.
  

•  Do not confuse consumers with overly complicated scientific terms for common conditions.
  

• You cannot make false claims about the product being a cure for an ailment or concern.
  

•  Do not encourage users of your product to use it excessively.  Claims tThat it is guaranteed to work, is absolutely safe, or has no side effects cannot be made unless you have proof of this.

This is just a very basic oversight of the advertising rules for medical devices. If you want to find out more, we recommend that you read CAP code 12 in full before starting on your marketing campaign.

Strategic Marketing

Marketing medical devices to UK audiences means following very specific rules and guidelines. The ASA and CAP play a key role in shaping these rules, keeping consumers safe, and setting a high standard for marketing communications. Medical device manufacturers can succeed in the market by responsible marketing strategies, evidencing claims with clinical proof, and following good advertising practices across a variety of media channels.  Marketing medical devices successfully is a balance between following rules and getting the message across well.

If you want to find out more, feel free to get in touch.