Jul 31

Eye drops – a medicinal product or a medical device?

Diagnosing an issue
A while ago I translated a user information document on eye drops called X. Since I didn’t want the text to be too repetitive in terms of using the product’s proper name, I asked a project manager what determiner I should use: a product, a drug or perhaps something else? After checking with the client, it turned out that these particular eye drops were… a medical device and under no circumstances should be referred to as a “medicinal product”. I had a closer look at the medicinal product vs. medical device classification and here’s what I found out.

A device – not necessarily electronic
The phrase “medical devices” isn’t only limited to “electronic medical devices”, yet there’re many Polish translations where this phrase is translated literally, suggesting that a product is an “electronic device” when it’s, for example, a hip implant. A more appropriate and a neutral term would be “wyrób”. Medical devices cover a broad range of products, with about 300,000 products currently on the market compared to “just” 4,000 medicinal products. “Medical devices” may include products formulated as tablets, capsules or drops, which, I suppose, can be the most problematic to decipher, as we tend to associate such formulations with “medicinal products” rather than the former.

In the European Union a “medicinal product” is defined as follows:
“(a) Any substance or combination of substances presented as having properties for treating or preventing a 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.’”

The definition of a “medical device” states:
“A “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;(…)”

Similarities and differences
As you can see, the similarities between the two terms pertain to their purpose which is to treat, prevent or diagnose a disease. Medical devices also have an additional role of alleviating a medical condition.
The fundamental difference between medicinal products and medical devices lies in their mode of action. Medicinal products’ mode of action is pharmacological, immunological or metabolic, while medical devices work through non-pharmacological, non-immunological and non-metabolic mechanisms and their function is achieved by physical means.

A medicinal product or a medical device? Guess!
Here’s a list of some products. Can you try and guess whether they’re a MP or a MD?
Artificial tears
Cardiovascular Stent
Implanted Urinary Continence Device
Pregnancy test
Surgical gloves
Vaniqa 11.5% cream
Alcohol and artificial tears can be classified both as a medicinal product or a medical device, Vaniqa is a medicinal product and the remaining products are classified as medical devices. It is always best to ask when translating.

More on differences
The differences between medical devices and medicinal products go much further. MPs are evaluated for safety and efficacy in randomised clinical trials, while the process for MDs seems to be less stringent, with clinical investigations required for devices of the highest risk, for example implants.
Medicinal products are approved by a competent authority which grants a marketing authorisation after a review of the documentation submitted by the applicant (most often a pharmaceutical company). With medical devices, it’s the manufacturer who’s responsible for assessing the risk.
Medicinal products can only be prescribed or dispensed by a licensed doctor or a pharmacist. With medical devices, this requirement is non-existent. Doctors must determine themselves if they are qualified enough to implant a cardiovascular stent, and it’s safe to assume that a GP would not undertake this procedure.
Another difference between these two classes is in the monitoring of their safety after launching them on the market. While for MPs there is the pharmacovigilance system is place, for MDs there’s very little or no post-marketing data.

To sum this up, medical devices and medicinal products differ in the following respects: MDs are a much diverse group of products, while MPs are more innovative. MDs are generally more durable than MPs. The main difference between them is in their mode of action. Medicinal products are heavily regulated and assessed in clinical trials and for medical devices there isn’t one regulatory body.
So, next time you need a determiner for a product in your medical translation, think twice or better – ask a competent person.

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