Everything ! ... with a Austin Powers guff laugh. In my own experience, based on the classification of the device, we put all marketing literature through quality system review, assigned a number, revision level, etc., especially for higher risk Class II products and Class III products. Lower classification products like Class I maybe you have more flexibility about not controlling every marketing brochure.
There are different ways to handle marketing literature not being so unwieldy for your marketing personnel, like at one company we had a completely separate marketing approval process. This was a process that was handled by marketing, it was an approval, numbers were assigned, but quality and/or regulatory also approved the marketing literature. Purpose for review was to confirm claims, statements, and references to clinical information. Under the EU MDR, this is going to be even more critically reviewed since the clinical evaluation needs to align with statements, risk, and claims that are made in
any type of marketing literature. I worked at a couple companies managing marketing literature like Brittany mentions, we controlled everything including websites. The regulatory aspects must be reviewed to make sure no claims, indications, or intended purpose of the device is being made that is not consistent with the regulatory filings, safety of device, and performance requirements.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Apr-2019 12:00
From: Brittany Gibson
Subject: Document Control - Marketing Literature
In my experience, we control websites, marketing material, promotional materials, pamphlets, brochures, etc., anything that makes a claim about the device or communicates its intended use.
The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. The term 'accompanying' can be interpreted to mean more than just physical or electronic labeling with the product itself. This can extend to posters, brochures, marketing material, websites, etc. It's important to review and control marketing/advertising material to ensure the product is being advertised per its intended use, and any claims made are substantiated with data.
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
Original Message:
Sent: 01-Apr-2019 19:33
From: Anonymous Member
Subject: Document Control - Marketing Literature
This message was posted by a user wishing to remain anonymous
Hi All,
We have an internal debate on which marketing literature needs to go through our QMS document control system.
My input was anything that has Instructions for Use or any type of record based information from the DMR that a physical property/composition/or related is displayed. Am I missing anything?
Some would like to put everything in the QMS (easier to manage) - unhappy marketing people.
I would like to proposes a solution that would keep us compliant and be the least restrictive to the marketing team.
Any thoughts would be appreciated.
Thank you,