Regulatory Open Forum

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

Dear Caterine,

I guess the topic concerns mainly skin care products.
I think the difference between medical devices and cosmetics comes from the indications (intended use) claimed in the instructions for use of the concerned products (and in case of medical devices the content of the clinical evaluation and the will of the Notified Body).

• 'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
REGULATION (EC) No 1223/2009 Article 2. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20160812&from=EN

• 'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
• or products belonging to Annex XVI. (EUMDR 2017/745)

If in the IFU there are claims with medical content about "prevention, … treatment or alleviation of disease/injury or disability or replacement or modification of the anatomy or of a physiological or pathological process", the product is expected to be categorised as medical device. 

I can imagine skin products, which – depending on the intent of the manufacturer – may be categorised as medical device or cosmetic.
A cream claimed to protect, soften skin exposed to sun may be a cosmetic, the same cream explicitly claimed to prevent sunburn by will be medical device.
I guess it is easier and faster to bring a cosmetic to market.

In this case the indications of use should be carefully worded to meet the
• commercial interest of the manufacturer,
• legal requirements,
• user/patient safety.

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

​Thank you Peter,

I would have thought that cream with medical claim would have become drug rather than medical device..

I have found the following definition for medicinal products:

(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

Wouldn't it apply to cream with medical claims? I guess that part (a) might. While, since the cream achieves its intended function via chemical , it seams to me that the definition of Medical Device would exclude it.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

Original Message:
Sent: 08-Feb-2018 16:32
From: Peter Miko
Subject: cosmetic or medical device?

Dear Caterine,

I guess the topic concerns mainly skin care products.
I think the difference between medical devices and cosmetics comes from the indications (intended use) claimed in the instructions for use of the concerned products (and in case of medical devices the content of the clinical evaluation and the will of the Notified Body).

• 'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
REGULATION (EC) No 1223/2009 Article 2. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20160812&from=EN

• 'medical device' means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
• or products belonging to Annex XVI. (EUMDR 2017/745)

If in the IFU there are claims with medical content about "prevention, … treatment or alleviation of disease/injury or disability or replacement or modification of the anatomy or of a physiological or pathological process", the product is expected to be categorised as medical device.

I can imagine skin products, which – depending on the intent of the manufacturer – may be categorised as medical device or cosmetic.
A cream claimed to protect, soften skin exposed to sun may be a cosmetic, the same cream explicitly claimed to prevent sunburn by will be medical device.
I guess it is easier and faster to bring a cosmetic to market.

In this case the indications of use should be carefully worded to meet the
• commercial interest of the manufacturer,
• legal requirements,
• user/patient safety.

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

Hello Caterina,

Sometimes it may be difficult to distinguish between a cosmetic and device:

For example, dermal fillers are classified as a cosmetic-device by the FDA.

Cosmetic: Dermal fillers are used to create a smoother, fuller appearance in the face. Therefore, it fits the definition of a cosmetic (REGULATION (EC) No 1223/2009 Article 2) since it makes contact with external features such as face, lips, etc.

Device: According the definition of device: prevention, … treatment or alleviation of disease/injury or disability or replacement or modification of the anatomy or of a physiological or pathological process (EUMDR 2017/745) and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

In the case of dermal fillers, they are modifying the anatomy but not via pharmacological action. Therefore, they fit the definition of a device.

Since they fit the definition of both-cosmetic and device, you can see why it may be difficult to distinguish between the two.

More info may be found here re: dermal fillers: Dermal Fillers (Soft Tissue Fillers)



------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

Dear Caterina, I think if the ingredients of a cream or ointment - which claimed to act as a  physical barrier on the surface of mucosa or the skin – are not listed as active substances in the Pharmacopoeias or in The Martindale The Extra Pharmacopoeia, the manufacturer may request medical device status. Even if several ingredients like sodium-hyaluronate may appear in pharmaceutical products as excipients, still products with sodium-hyaluronate are frequently categorised as medical devices (dermal fillers, eyedrops, wound dressings, ophthalmic viscoelastics and intraarticular injections). The same applies on hydroxy-propyl-methylcellulose or macrogol. In other cases, very similar products are marketed both as medicines and medical devices. So, this is not black and white. A lot depends on, how the IFU and the Clinical evaluation report is worded and what are the claims of the manufacturer.

------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
------------------------------

Original Message:
Sent: 09-Feb-2018 10:53
From: Saurabh Kothari
Subject: cosmetic or medical device?

Hello Caterina,

Sometimes it may be difficult to distinguish between a cosmetic and device:

For example, dermal fillers are classified as a cosmetic-device by the FDA.

Cosmetic: Dermal fillers are used to create a smoother, fuller appearance in the face. Therefore, it fits the definition of a cosmetic (REGULATION (EC) No 1223/2009 Article 2) since it makes contact with external features such as face, lips, etc.

Device: According the definition of device: prevention, … treatment or alleviation of disease/injury or disability or replacement or modification of the anatomy or of a physiological or pathological process (EUMDR 2017/745) and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

In the case of dermal fillers, they are modifying the anatomy but not via pharmacological action. Therefore, they fit the definition of a device.

Since they fit the definition of both-cosmetic and device, you can see why it may be difficult to distinguish between the two.

More info may be found here re: dermal fillers: Dermal Fillers (Soft Tissue Fillers)



------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

​The part of the definition you cite distinguishes drugs from medical devices. The distinction between a cosmetic device and a medical devices is found elsewhere in the definition:

"...intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes..."

Whether a device is a cosmetic device or a medical device (or maybe neither one) is determined by the use intended by its manufacturer, which in practice means it is determined by the intended use described in the labeling.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

​Thank you so much - having my background focused on Medical Device, the insight on the Pharma roles and tools has been precious.

I thought cosmetics would have been a much simpler field, but it turns out to be a considerable fourth player!


------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------

Original Message:
Sent: 08-Feb-2018 09:22
From: Caterina Puddu
Subject: cosmetic or medical device?

​​​Hello,
reading the (EU) 2017/745 assumptions, one finds [Whereas … (9) … in some cases it is difficult to distinguish between medical device and cosmetic products].

Since the word "product" has been chosen instead of "device", I would assume the regulator is referring to chemical products (e.g. cream, ointments ...)

Standing the definition of medical device [does not achieve its principal intended action by pharmacological ... means], I wonder how there could be any confusion in distinguishing the two?

Some example would be much appreciated.

Best,
C.

------------------------------
Caterina Puddu
Malmesbury
United Kingdom
------------------------------