Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

I came across a Class III device manufacturer that needs to create marketing material to launch their first device to the EU market. They said they can't base the marketing on their own or other related clinical studies (even though they back up the intended purpose, clinical safety and performance and are published in industry journals) or other product information they have shared on their website, social media and mass media, "because it's a class III device".

This sounded like an odd claim. I wanted to ask the community that are there rules that control the marketing of EU MDR Class III devices - other than EU MDR Article 7?

Thank you in advance.

Hello Anon,

Hmmm no, though there may be some "legal" interpretation through various points in the EU MDR of higher risk Class III devices they may be construing as not being able to make marketing claims.  As far as I know as long as there is supporting evidence of claims, a company can base their marketing on those evidences like clinical studies.  Again, there may be internal legal issues which is preventing them though nothing beyond information in Article 7 and supporting Annex I would prohibit these activities.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Nov-2021 13:04
From: Anonymous Member
Subject: Class III (EU MDR) device marketing claim rules

This message was posted by a user wishing to remain anonymous

Hi,

I came across a Class III device manufacturer that needs to create marketing material to launch their first device to the EU market. They said they can't base the marketing on their own or other related clinical studies (even though they back up the intended purpose, clinical safety and performance and are published in industry journals) or other product information they have shared on their website, social media and mass media, "because it's a class III device".

This sounded like an odd claim. I wanted to ask the community that are there rules that control the marketing of EU MDR Class III devices - other than EU MDR Article 7?

Thank you in advance.

Sure there are rules that control the marketing of devices other than the MDR: they're in national law or national self-regulatory rules, since article 7 MDR is not complete harmonisation of advertising of medical devices.
These rules will differ from one member state to the other. Some member states will for example regulate advertising of prescription medical devices to the general public (which is harmonised for medicines under Directive 2001/83, but not for devices).
Also, there are general EU adverising rules for which medical devices are also in scope, such as the Misleading and Comparative Advertising Directive (Directive 2006/114).
But it is kind of broad statement for the manufacturer to so that they "can't because class III", because that would not follow from the MDR alone, so there's something else.

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 10-Nov-2021 13:04
From: Anonymous Member
Subject: Class III (EU MDR) device marketing claim rules

This message was posted by a user wishing to remain anonymous

Hi,

I came across a Class III device manufacturer that needs to create marketing material to launch their first device to the EU market. They said they can't base the marketing on their own or other related clinical studies (even though they back up the intended purpose, clinical safety and performance and are published in industry journals) or other product information they have shared on their website, social media and mass media, "because it's a class III device".

This sounded like an odd claim. I wanted to ask the community that are there rules that control the marketing of EU MDR Class III devices - other than EU MDR Article 7?

Thank you in advance.