I know this can seem a stupid question to answer for some of you but I can tell you that the Medical Device Regulation in Europe is making some progress. So it’s worth the time to review the changes on the Definition of Medical Device.
So “what is medical device?”
Don’t be surprised if some new products are considered medical devices when they were not before. We can say that the medical device classification Europe is changing but the change is not so important.
MEDICAL DEVICE DEFINITION IN EUROPE
What is the difference between a Directive and a Regulation?
Let’s first review the definition coming from the Europe Union Website.
What is a Directive? (European Union Definition)
A “directive” is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. One example is the EU consumer rights directive, which strengthens rights for consumers across the EU, for example by eliminating hidden charges and costs on the internet, and extending the period under which consumers can withdraw from a sales contract.
To make it simple, the Directive gives some direction to all Member States on which result they should achieve and by when.
Each National Authority must create or adapt their legislation to meet these requirements. They can decide freely how to transpose the directive into National law.
And now let’s look at the Regulation definition
What is a Regulation? (European Union Definition)
A “regulation” is a binding legislative act. It must be applied in its entirety across the EU. For example, when the EU wanted to make sure that there are common safeguards on goods imported from outside the EU, the Council adopted a regulation.
For a Regulation, it’s more direct. It is legally entering in force in all Member State. No need to try to adapt anything.
All that is written is applied by a set date.
Erik Vollebregt explaining the difference between Directive and Regulation
Definition of a Medical Device in Europe
Youtube Video: "What is a Medical Device?"
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Medical Device definition from the Medical Device Regulation MDR 2017/745
‘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 sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
If you are asking yourself if your product is a Medical Device, you need to understand that this definition is related to the intended use of your product.
Definition of an Accessory to a Medical Device
You would think that an accessory to a Medical Device is less important than the medical device itself.
I will show you that the new MDR is considering accessories as similar to a Medical Device so be careful when you have to evaluate them.
Definition of an accessory
First let’s start with the official definition:
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
While reading the EU MDR 2017/745, you see some sentences that are really interesting.
One of them is located in Article 1(4):
For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
So it means that wherever you see the word “Device” on this regulation, you can replace it by:
- Medical Devices
- Products from Annex XVI
If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used.
If you have a Medical Device and some accessories to it, you should then assess the class of each of them separately.
It means also that you should gather all the documents that are required for a device with this class.
Definition of intended use
On the definition of a Medical Device, there is one word that is important.
This word can be completed with words like use, action, purpose. The idea is for you to officially define what is your product made for.
The intended use definition.
A similar product can have many intended uses. I imagine for example an endoscope.
You can use it on humans, and then it becomes a medical device. But if you use it on animals, it falls on the veterinary products. [For information, veterinary medical devices are not regulated at the European level but by each national authority]
This definition is also important for combination products.
First question for you
- If you have a syringe prefilled with a drug. Is this a Medical Device or a Drug?
- It’s a Drug as the primary intended use of this is for the patient to receive a medicine. The syringe is only a medium to reach that objective.
Other examples of Drug which combines with a Medical Device:
- Non-reusable autoinjectors containing a medicinal product as an integral part
- Nebulizers precharged with a specific medicinal product
- Patches for transdermal drug delivery
- Wound dressings impregnated with an antibiotic, where the primary intended
the purpose is to administer the antibiotic to the wound
- Bone void filler with animal growth factors, where the action of the growth
factors cannot be demonstrated to be ancillary to that of the physical filler
What about this one?
- And now if you have stents that are covered with some drug. Is this a Medical Device or a Drug?
- It’s a Medical Device as the primary intended use of the stent is to maintain the artery open. The drug is only here to help the stent.
Other examples of Medical Devices that integrate a Drug:
- Catheters coated with heparin or an antibiotic
- Soft tissue fillers incorporating local anesthetics
- Implantable infusion pump
- Spacer devices for use with metered dose inhalers
- Bone void filler with an antibiotic
- Bone void filler with animal growth factors, where the action of the growth factors is demonstrated to be ancillary to that of the physical filler
Is your product a Medical Device?
To help you define if your product can be considered as a Medical Device in Europe I created a tool for you. It’s just a few questions to answer and you should get a quick feedback with a report received per email. See below
Look at my other contents
Definition of an Active Medical Device
On the different kinds of devices that exist, there are active devices.
Let´s clarify which products are falling under this category:
The definition from the MDR 2017/745 Article 2 paragraph 4 says:
‘Active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device;
So any device that works with electricity to for example run a drill (like a power tool) or to use that energy to run software is then an active device.
And under the active device definition, there are 2 more definitions to present (Annex VIII paragraph 2.4 and 2.5:
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
So this is an active device that is used to really act on the patient´s disease.
And then there is the other kind of active device, which are:
‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
In that last case, those devices are more helping you to find what is the situation of the patient. It´s not treating anything.
Why is it so important to know that?
It´s important for the classification of your medical device. This vocabulary is used on the different rules in annex VIII to find what is the class of your product.
So if your product is an active device, this can change its classification and change also all the rest for you.
As seen a Software is considered as an active device so don´t forget to look at this article to know more about SAMD (Software as a Medical Device).
New Medical Devices Product
On the new regulation MDR 2017/745, there is a new Annex XVI with product that should be now considered as medical devices.
The annex is called “List of groups of products without an intended medical purpose referred to in Article 1(2)”
As you see they mention specifically that those product do have no medical purposes. For now there is 6 products that are listed:
Cosmetic contact lenses to change color of the eye will now be considered Medical Devices
I suppose that they talk about cosmetic implants, or even trackers that are implanted on the hand to see where you are located or for you to open doors… Maybe
It is focused on Botox or Hyaluronic Acid. This is injected under the skin to look younger but it should have no physiological or metabolic action.
So here it’s clear. This is only a cosmetic purpose.
Have you ever seen those new devices with light pulsed that are used to remove hair. Even equipment for sunbathing would be included.
This is the future and we are their. Do you imagine those equipment that can help us to sleep or that can interact with our brain… This is cool no. They are now medical devices.
If you plan to manufacture or sell one of these products in future, I would recommend to learn more on Medical Devices as your business will be at risk.
If you are located in European Union, you should already have a Notified Body that can help you to identify your product.
But in the case you are outside of the European Union and don’t distribute your product to EU for now, there is some steps you need to follow before to invest anything. One of them is to identify an Authorized Representative.
Borderline Medical Devices
Even with all the definition possible, there are some cases that are still at the border of every regulation.
What to do in that case?
The European Union did create a “Manual on borderline and classification”. This is a document that is regularly updated and offers also some advice on some products.
This document is divided into different sections as:
- Medical device/In-Vitro Diagnostic Medical Device – Medical Intended purpose
- Borderline In-Vitro Diagnostic medical device
- Borderline Active Implantable Medical Device – Medical Device
- Borderline Medical Device – Medicinal Product
- Borderline Medical Device – Biocides
- Borderline Medical Device – Cosmetic Products
- Accessory to a Medical Device or an In-Vitro Diagnostic Medical Device
- Classification (Review class of borderline products)
- Software and mobile applications
As mentioned, this manual is updated regularly so if you have some topics related to that, don’t use a copy you downloaded but always review the last copy on the website.
Medical device classification in Europe
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- Class I (class 1)
- Class IIa (class 2a)
- Class IIb (class 2b)
- Class III (class 3)
Additionally, there are 3 more categories that are part of class I:
- Class Is: Products that are part of class I which are sterile
- Class Im: Products that are part of class I which have a measuring function
- Class Ir: This one is new. It’s for reusable surgical instruments
This last class is also new. I call it “Ir” for reusable or reprocessing but I don’t know if officially the moderator will call it like that.
Notified Bodies will particularly look to the aspect of the reuse of the devices.
Particularly cleaning, disinfection, sterilization, maintenance and functional testing and the related instruction for use of it.
All the classification rules are available on Annex VIII of the Medical Device Regulation MDR 2017/745.
Medical device classification examples
- Class I: Non-invasive electrodes (for ECG or EEG), Stethoscopes for diagnosis
- Class IIa: Adhesives for topical use, stents
- Class IIb: Urethral stents, tracheal cannulae
- Class III: Brain spatulas, spinal needles
Another example of class III medical device is Software as a Medical Device. This can also be critical so you need to learn more on this as there will be more and more. Learn more
To help you on your learning journey on the classification of EU Medical Devices you can also have a look at this post. Beginners Guide: New EU Medical Device Classification
The new Medical Device Regulation is also making some changes to some products that change their classification. For example, the “spinal inter-vertebral body” was classified IIb and now it will be classified III. So more requirements for some orthopedic companies.
LEARN MORE: Free Mini-Course MDR 2017/745
I think you have made enough progress on the European Union Regulation. Now let’s review some other countries.
We should start first with the United States of America.
Medical Device made Easy Podcast
To complete your learning on the topic, here is a podcast episode called “Is my product a Medical Device?”
You can have a look at the webpage at https://podcast.easymedicaldevice.com
Don´t forget to subscribe to get notified for any new episodes. On the webpage, there are all the places where it is available.
UNITED STATES OF AMERICA
FDA definition of Medical Device
The “Food and Drug Administration” do also have a Medical Device definition. It helps to make a distinction with all the other products regulated by FDA such as drug.
Here is the extract that you can find at this address: LINK
“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).
Which Medical Devices need FDA approval?
Ok, here I have some comments to make. We can see that there is a major difference between the EU and US medical device definition.
First, in USA, a Medical Device is for Humans or other animals. So veterinary products and Human products are considered similar.
If you run a veterinary business in Europe, you should be careful regarding the requirements as its different than what you would expect.Then, “Software functions” are excluded from this definition.
For sure, I’ll need to deep-dive on the section 520(o) on another post to give you more information on this.
Different classes of medical devices in USA
- Class 1
- Class 2
- Class 3
Each of those classes do need a different way to put the product on the market. If you are located in USA, this could be simple.
For a foreigner, you’ll need to find a local agent to be your representative for your products.
Examples of each device class
FDA is having a website where they display a database with all products registered and their classification. Here are some examples from this site:
- Class 1: Cleaning brushes for an endoscope, saliva paper
- Class 2: Infusion pump, Germicide, cleaning for endoscopes
- Class 3: Acid Hyaluronic intraarticular, Absorbable Coronary Drug Eluting Stent
FDA Site: Product Classification
Let’s not stop only at the USA and Europe. I want to show you also what is the medical device definition for other countries as Brazil with ANVISA and China with CFDA.
I will try also to make a comparison to see the differences.
Let me know if you have some comments.
Medical product: healthcare product, such as equipment, devices, materials, articles, or
systems for medical, odontological, or laboratory use or application, intended for prevention,
diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological,
immunological, or metabolic means to fulfill its main function in human beings, but can have
its functions assisted by such means
Obviously, it looks not so different than the other countries. This definition is shorter but includes all the specificity of a Medical Device. We only see that the word “Software” is not mentioned. It also includes the distinction with a borderline product (Medical Device or Pharmaceutical).
In Brazil, there are 4 classes of medical devices : Class I, II, III, IV.
“Medical devices” as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
- Investigation, replacement or modification for anatomy or a physiological process;
- Control of conception.
For China, it’s similar. The vocabulary used is the same as for the European Union. It also is specific to Humans.
For the classification, they use 3 classes: Class 1, 2 and 3.
Logically, the definition of medical devices is in majority similar in most of the main countries.
The main aspects are:
- The category of products
- The main intended use should not be by a pharmacology, immunology or metabolic means.
- The medical function
However, there are also differences. The definitions are not all aligned on the “Softwares”. And only the United States are considering veterinary products on the definition of Medical Devices.
Finally, the class of products are not similar. Maybe to keep some specificity for each country.
But, even with all this, there is still some problems. You will see if you are dealing with some health authorities.
The agents are using some exotic interpretation from the definitions. This can hurt your business as each party don’t understand the same vocabulary.
To avoid any interpretation on a Medical Devices definition, the European Union updated the new MDR 2017/745 to include clear vocabulary.
It helps the manufacturers and the health authorities to speak the same language and provide the best support to Patients.
However, the new MDR 2017/745 created a surprise by creating a specific annex to some products that were not considered medical devices before.
Because the intended use was not specifically matching the definition. But when you look at those device, for sure they should be considered as medical devices.
I hope this article helped you to enter the world of Medical Devices. I am sure you still have a lot of questions and I will continue to create more articles to answer them.
Don’t hesitate to provide your comment and also share this article on your social network.
Thanks for your support and “Au Revoir!”
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at firstname.lastname@example.org or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.