Are you planning to, or in the process of, developing a medical device but aren’t sure how to classify your device according to MDR 2017/745? Or maybe you haven’t had the time to really get to understand the classes and classification rules yet.
Don’t worry, in this blog post you will get an overview of the MDR medical device classes and classification rules, and hopefully some inspiration on where and how to start.
So, why is the class of our medical device important? Because that is what tells us what actions we need to take before placing our product on the market and start selling it. Most of the results of these actions are going to end up as parts of the technical documentation sent to our Notified Body (MDR 2017/745, Annex II); our proof of the safety of our device. And the higher the class of our medical device, the higher the risk, so the more proof we need to provide.
Overview of the different medical device classes
Classifying your medical device can seem like an overwhelming task, especially if you have a more advanced product. However, if you read through MDR 2017/745 and all relevant MDCG documents, you will find a lot of information helping you to set the correct classification.
Easy right? OK, we understand, there is a lot of text to go through. That is why we have created this overview for you.
To start with, medical devices are divided into four classes according to EU MDR 2017/745:
- Class I
- Class IIa
- Class IIb
- Class III
Class I is for low-risk products and Class III for the highest risk products (MDR 2017/745, chapter V, section 1, article 51).
What do you need to know beforehand?
As in all aspects of life, you need to plan before you start executing. First of all, you need to know the intended purpose of your product before you begin. The intended purpose is explained by MDR as “The use for which a device is intended according to the data supplied by the manufacturer.” (MDR 2017/745, chapter 1, article 2, section 12). In other words, how and for what do you intend it to be used?
Furthermore, you will need to know the duration of use for your product (MDR 2017/745, annex VIII, chapter 1, section 1):
“normally intended for continuous use for less than 60 minutes.”
“normally intended for continuous use for between 60 minutes and 30 days.”
“normally intended for continuous use for more than 30 days.”
Also, you need to know if your product is invasive and/or active (MDR 2017/745, Article 2, point 4 and 6):
An 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.”
An invasive device means
“any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.”
And lastly, there are also implementation rules which explain the classification under certain circumstances, e.g. if your product is used in combination with another medical device, or if your product contains software (MDR 2017/745, annex VIII, chapter 2).
So, finally we come to the part where we actually find out which class our medical device will have.
The classification rules are divided into:
- Non-invasive devices
- Invasive devices
- Active devices
- Special rules
Each classification rule under the above rulesets defines the applicable types of products and to which class it should belong (i.e. I, IIa, IIb or III) for the specific rule.
Is it really this easy? Well, not always. Following the steps above will definitely help you find the right class for your product, but sometimes it can be a little more complex, for example if you have more advanced devices, that are based on new technology or borderline products (i.e. is it a medical device or something else?). There might also be additional legislation, directives and standards to consider for certain medical devices.
One area we will cover in a future blog post is medical device software, which is becoming more relevant in the future, with the continual development of, for example, medical device AI-based tools and apps. This is an entire subject in itself and deserves its own blog post, so keep an eye out for it.
As explained in the beginning of this blog post, the class of your medical device determines what Technical Documentation to provide to your NB for product certification. So, how should you go about this? Don’t worry, we will cover that in a blog post soon.
It is always a good idea to reach out to experts in order to classify your medical device. This will usually save you both money and time. Our medical device compliance experts at MedQtech are ready, should you need any help. So, don’t hesitate to contact us!