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Barrier cream classification

MedicalDevice

Starting to get Involved
#1
Good morning everyone!

I came across a specific medical device product that is described as a "Barrier Cream"
Some indications that come with it are the following:
• Suitable for wet areas
• It helps maintain the pH of the skin and skin moisture.
This product is applied to intact and at-risk skin to provide protection from body fluids and moisture. It can be applied around wounds, wound dressings and incontinence pads where a protective barrier will help prevent skin breakdown.

Could someone help me to classify this medical device? From my point of view, it is a (Rule 4) Class I MD. But I have had a discussion with a friend that thinks it's Class II. Any feedback would be helpful.
 

Sullen-gent

Starting to get Involved
#2
Hi,

I worked with products previously that were barrier creams and they were class I. However would be careful as it very much depends on the claims and the nature of contact. Above you said 'intact' skin so could argue Rule 1 is appropriate (contacting intact skin). However you also mention wounds and this is more rule 4 territory where the skin is damaged or the dermis is breached or the product manages the wound environment.

This is all MDD and there are some changes under MDR to these rules but they don't look massively different on face value.

I think this cream is likely to be class I, as barrier creams act as a shield to stop healthy skin (rule 1) becoming damaged or protect damaged skin (rule 4) from further damage but it would be the claims of the device that could push it further into risk classification.
 
#3
However you also mention wounds and this is more rule 4 territory where the skin is damaged or the dermis is breached or the product manages the wound environment.
Yes, I agree, your claims may push the classification up - and it is foreseeable that patients may use it on wounds given your description.

There is an entry in the borderlines manual for zinc oxide creams that may/may not be useful:

4.6. Zinc oxide containing creams
- Background
Products containing zinc oxide are available as creams for local administration.
Some zinc oxide containing products, depending on their claims and intended use, might be covered by Directive 76/768/EEC on cosmetic products.
The discussion below only concerns zinc oxide containing products used to treat or prevent minor skin irritations (e.g. burns, cuts, nappy rash, eczema etc.).
- Outcome
A medical device should not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.
For zinc oxide containing products, according to the literature, a pharmacological and metabolic action is demonstrated, e.g. may play a role in enzymatic processes, support of wound granulation.
The pharmacological action may, however, be ancillary when the product concerned is primarily a barrier cream.
In such cases the qualification of zinc-oxide containing products is defined taking into account the claims, the intended purpose and the relevant primary mode of action. Some products that act primarily as a barrier may therefore be acceptable as Class III medical devices in accordance with rule 13 of Annex IX of Directive 93/42/EEC.
In accordance with Article 2(2) of Directive 2001/83/EC, in case of doubt where taking into account all product characteristics, and provided that the concerned product meets both definitions of a medicinal product and of a medical device, the provisions of Directive 2001/83/EC shall apply.
 
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