For some devices, it's a no-brainer whether or not it's a medical device.
- Of course a surgeon's scalpel is a medical device!
But what is the difference between that and a super-sharp Japanese kitchen knife?
- Of course the thermometer to measure body temperature is a medical device!
But how does it differ from the device that is used to measure meat temperature while cooking?
- On the other hand, your average watch, even if it's a smart watch is not a medical device.
But what's different in the new Apple watch that obtained FDA clearance?
When is a device considered to be a medical device?
It depends on the intended use, the intended patient population, the claims you make, the situation and environment in which it's used, which market you are looking at...
What is a medical device?
Let's start with the definition of a medical device.
- According to the Medical Device Regulation in Europe:
‘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:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 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.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
- According to the FDA in the USA:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).
- According to the World Health Organization:
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices
- providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
- disinfection substances,
- aids for persons with disabilities,
- devices incorporating animal and/or human tissues,
- devices for.in-vitro fertilization or assisted reproduction technologies
These are just a few examples. All are quite similar but you have to look at the details to know whether or not your device would be considered a medical device in the market you want to target.
This means that if you (or your marketing team) wants to make claims that are related to prevention, diagnosis, treatment, alleviation of a disease or a disability, it might bring your device into a medical device category and therefore within the scope of regulations that will impose new/different requirements on your device. In this case, it's important that all departments are involved in creating/reviewing the claims and intended use of devices in order to define the proper regulatory strategy for them.
For some devices it is indeed very clear whether or not they would be a medical device. However, there are definitely borderline devices.
To give some guidance and examples on whether or not a device would be a medical device, an in-vitro diagnostic device, a biocide, a cosmetic product, a drug or not, there has been a manual published by the European Commission in 2017. Note that this is based on the definition of a medical device and in-vitro diagnostic under the European Directives, a similar document does not yet exist for the new Regulations.
After reading and analyzing, it might still not be clear whether or not your device is considered to be a medical device or not. In that case, ask the authorities for help.
In the USA, you can first of all search the CDRH database for guidance and if that doesn't give you the answers needed, you can contact the FDA with your questions. More info can be found here.
In Europe, you can seek guidance from your local competent authority (national authority dealing with medical device regulations).
Not now, maybe later?
If you have a device that at this point doesn't fall within scope of the medical device legislation, but it might be when you add certain features or change some of the claims, what should you do?
Make sure you have the resources.
Bringing a medical device to the market does cost time and money.
Investigate what would be the classification of your device and what that means in terms of market approval. Which standards apply? Which tests would need to be performed on the device? How will you manage your clinical evaluation? Do you need to involve a notified body? Would you need to apply for 510(k) or PMA? What are the costs involved? What is the process to follow?
In any case, it's a good idea to start building your QMS according to the requirements. If needed, it will speed up the certification.
So, it's better to do your homework upfront so that you know what to do when you would enter the world of medical devices or in-vitro diagnostics.
Interested in seeing how we can help you getting started with both your QMS as well as your medical device files? Please visit the Matrix Requirements website!