Do you want to learn how to classify your medical devices in Europe?
You are at the right place. I will teach you all about the EU MDR classification.
Not with the MDD 93/42/EC classification rules but the new one, the EU Medical Device Regulation 2017/745 (or EU MDR 2017/745) that will be mandatory from May 2020 (Unless transition period is extended).
By the way, I created a Mini-Course to teach you everything about the new Medical Device Regulation EU MDR 2017/745, and this is free. Have a look at the link below and register to be enrolled
I propose to present you the different categories of the medical device classification with some comments. And also to offer you a free pdf documents to help you succeed on this classification.
It will include:
- Cheat Sheet as an Infographic
- New Medical Devices Classification EU Form “Fillable Pdf”
We all know that some special cases occur, so I also include on this article some words on the Medical Device Borderline Manual to help you classify products that are more difficult.
And I include also a chapter in the case your Notified Body disagree with you regarding the classification of your device. There is a solution but it will still not be a magical one. So keep in contact with your Notified Body.
At the end of this article I prepared a Quizz for you so you can test if you understood everything.
Video on how to classify a Medical Device
This is my first video, and I included on it a small game so you can test your knowledge.
I hope you’ll like it and also will subscribe to the channel as I provide you with so many information.
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Table of content
- How many class does exist?
- What are the different categories of Medical Devices?
- Medical Device Classification rules
- Europe Medical Device Classification Infographic
- List of new products considered as medical device
- Example of Medical Device Class (With infographic)
- Method to classify
- Case Studies
- How to classify a Software?
- Medical Device Borderline Manual
- MEDDEV 2.4/1 Guidance for medical device classification (93/42/EC)
- Article 51 - Dispute between the Manufacturer and the Notified Body
- PDF Presentation on Slideshare
- Quizz: EU Medical Device Classification
How many class does exist?
The EU MDR 2017/745 has 4 main categories for Medical Devices classification:
- Class I
- Class IIa
- Class IIb
- Class III
This goes from the products with low risk (Class I) to the products with high risk (Class III).
You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51)
But if you want to be more specific, we can say that there are 3 sub-classes under class I.
- Class Is: It’s a class I product that is delivered sterile
- Class Im: It’s a product with a measuring function
- Class Ir: New sub-class for products that are reprocessed.
And for those 3 sub-classes, A notified body should be involved for the certification. But only for the specific sub-class (Sterilization, measuring function or reprocessing validation)
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What are the different categories of Medical Devices?
The duration of use and definition of the different product categories are nearly similar. Some change of vocabulary to maybe make it clearer but meaning is similar.
- ‘Transient’ means normally intended for continuous use for less than 60 minutes.
- ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
- ‘Long term’ means normally intended for continuous use for more than 30 days.
This remains the same and we should be happy for that. Why? Because all products that were put on the market with the Directive 93/42/EC should be reviewed as of May 2020 with the new Medical Device Regulation 2017/745.
So if the duration definition change, most likely, you should completely reconsider your product and this can also put your company at risk.
I will not copy paste all the definitions from the MDR 2017/745 Annex VIII. You can find them on our resource page under the European Flag.
There still the distinction between a Body Orifice and an orifice made through the surface of the body. Surgical devices, reusable surgical instrument, active therapeutic device, central circulatory system, central nervous system…
I really advice you to understand each definition as this is key to classify your product. But if your medical device is not linked to any body orifice, not surgical, not active, not touching injured skin, not linked to any system (nervous or circulatory) then it should be easy for you to classify it.
I think we say “The devil is hidden on the details”
Medical Device Classification rules
The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices.
You’ll find all those rules on the Medical Device Regulation MDR 2017/745 Annex VIII
- Rule 1– Non-invasive devices
- Rule 2 – Non-invasive devices intended for channeling or storing (Which includes cells)
- Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids, other liquids and cells
- Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane
- Rule 5 – Devices invasive in body orifices
- Rule 6 – Surgically invasive devices for transient use
- Rule 7 – Surgically invasive devices for short term use
- Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc)
- Rule 9 – Active therapeutic devices intended to exchange or administer energy
- Rule 10 – Active devices for diagnosis & monitoring, emit ionizing radiation
- Rule 11 – Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes (from class I to class III)
- Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances
- Rule 13 – All other active devices
- Rule 14 – Devices incorporating a medicinal substance including human blood or plasma
- Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases
- Rule 16 – Specific disinfecting, cleaning and rinsing devices
- Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation
- Rule 18 – Devices utilizing non-viable tissues or cells of human origin or tissues of animal or derivatives
Four new rules:
- Rule 19 – Devices incorporating or consisting of nanomaterial
- Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation
- Rule 21 – Substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed
- Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management
Technical Documentation Templates
- Template compliant to requirements of MDR 2017/745 Annex II and III.
- Formatted with the chapters already defined.
- Guidance provided to help you identify the content to include
- General Safety and Performance Requirements compliant to Annex I.
- Include guidance to prove evidence to the requirements.
Europe Medical Device Classification Infographic
Here is a Cheat Sheet I created in the format of an Infographic. Print it and keep it close to you to have a quick answer to your questions.
As you may see, the number of rules for the EU Medical Device Classification increased between the MDD 93/42/EC and the EU MDR 2017/745 (Participate to the free mini-course).
4 new rules came in the game.
List of new products considered as medical device
Annex XVI includes the following products as devices for the first time. But the European Union Commission has the right to include more products. So this list may change in future.
It is interesting is to see which strategy these companies will use to comply with this regulation when they were not obliged before.
List of the products aesthetic and wellness products:
- Contact lenses or other items intended to be introduced into or onto the eye. e.g. colored contact lenses without correction of vision.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
Medical Device Classification Examples EU (With infographic)
I wanted also to provide you a quick infographic to help you have an overview of the different classes with an example for each.
You also need to understand for which class we need a Notified Body and which product can be self-assessed.
This infographic is divided in 4 areas:
- Risk level: What is the risk level for the class of product
- Class: The class number
- Examples: Few examples of devices for each class
- Assessment: What you need to register your product
Let me provide you with some medical device classification examples in Europe for each class:
- Class I: Wheelchair, otoscope, stethoscope, scalpel, plaster
- Class I (Special): It can be the same products as listed on class I but with special aspect.
- Measuring function
- Delivered Sterile
- Reprocessed to be reused as the scalpel
- Class IIa: Syringe which delivers a medicine, Teeth implant, X-Ray Device and Tracheotomy tubes
- Class IIb: Blood bag, implantable plate, screws and Condoms
- Class III: Drug coated stent, spinal disc cage, breast implants, pacemaker
Method to classify
To classify your product, you have the hard way:
- Decide which category is your device by looking at all the definitions.
- Look at each rule from first to last. If many rules are applicable, you should take the one with the highest risk
- If your product is borderline (Mix Drug – Device), you need to identify the main intended use.
An easier way:
I created a free form that will really help you to classify your product and also to archive your data electronically. It’s a fillable pdf where you can provide all the information of your Medical Device and select which classification is applicable. Read more on going through the below link.
View More: Free to download EU Medical Device Classification Form
Free PDF Medical Device Classification EU Form
Download this free PDF medical device classification form to make this process easier.
Case Studies
I think we discussed a lot of theory now and I am sure you will be happy to test yourself and see if you understand the method to classify a device.
In this video that I have recorded Live in Linkedin, I have provided some examples of products and then we defined together if this is a Medical Device or not.
You will see that during the live there was some debate for which rule should be used. In reality, if you don’t know perfectly the product you can be wrong.
Let’s see if you liked it. Don’t forget to subscribe to the Youtube Channel as I am publishing a lot of videos about Medical Device regulations.
And don’t forget to write a comment even if it is just to say that you liked the exercise.
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You can also download the slides used during this video from the show notes.
Let’s continue now and try to be more precise about some of the questions I received. Don’t hesitate to write some questions on the comments so I will try to update this article with the answer.
MEDDEV 2.4/1 Guidance for medical device classification (93/42/EC)
For those that are still working on the MDD 93/42/EC, something that was great was the support of MEDDEV guidance. I hope there will be the same support for MDR.
But for those that want to see how this look like, here is the link to the MEDDEV 2.4/1 for the classification of medical devices.
What is interesting on this MEDDEV is that it provides a lot of examples of products per class. So if you are asking yourself if a plaster is class I or more, you can download this guide and check.
I suppose that most of those example will remain true for the MDR, so in case you are struggling to find the class of your product, you can try to have a look to this guide.
How to classify a Software?
The new Medical Device Regulation is completely changing the way we look at software. Before the majority were Classified as Class I but now it’s different as we can do so many things with them.
I create a specific article on Software, so I encourage you to go and check it. It will provide you all the information you need to know from “Is my software a Medical Device?” to “Clinical data for a Software”…
Medical Device Borderline Manual
In the case you are still not sure of the classification of your product, it exist also another solution.
There are some products that are really borderline between many regulations.
The European Commission issued a Medical Device Borderline Manual. This is a document that is regularly updated which provide you with case studies.
So look at it regularly because the update can be to add products or to remove some of them. Recently some products were removed from medical devices list as:
- Rugby helmet
- UV flow germicidal lamp
- Autopsy saw
- Water filter
- Phaseolus vulgaris extract used in dietary products
So lets look now at a case I personally experienced.
For example, I had to use this Boderline Manual when I was working on a pharmaceutical company that produced eye drops.
But those eye drops didn’t had any active ingredient and would be then considered as Medical Device.
But I wanted to understand what is the classification for that. The rules where not clear so I looked at the Borderline Manual and find them inside.
I was happy because the description of the case was exactly similar to my product. And on one of the paragraph, it provided me with the class of this kind of device.
This is for now still linked to MDD 93/42/EC and other current laws. But I hope they will continue to have that for the MDR and IVDR.
Check link below to look at the Medical Device Borderline Manual.
Article 51 - Dispute between the Manufacturer and the Notified Body
Sometime this happens. You look at Annex VIII and find a sentence that match with your product. So you classify it following that rule.
But the Notified Body when reviewing your product, says NO. This is not the right rule used. This other rule looks better. So he rejects your dossier.
Oh my god!!! What Happened now? What should I do?
To be honest, this is a bad situation. And the MDR regulation 2017/745 created Article 51 for this case.
On article 51(2) it says that in case of a dispute between the Manufacturer and its Notified Body, they should look for a decision of the Competent Authority where the manufacturer has its registered place of business.
Or if you use an Authorized Representative, it’s the competent authority of your its registered place.
Sorry for making it more complicated, but when your Notified Body has it’s place of business in a different member state than the manufacturer, then it’s more difficult.
The Competent Authority of the Manufacturer has to consult the Competent Authority of the Notified Body.
Does this solve your issue. NO.
No timing is defined, so this can take a lot of time.
I stop here, to not make it more difficult for you to understand, but the MDCG (Medical Device Coordination Group) of the member state of the manufacturer should be involved.
So, if you have no other choice, use this article (I cannot promise any timing for results).
But if you have the possibility to discuss with the Notified Body to provide your arguments or to agree with them it will take you less time then.
Need help
Contact me
PDF Presentation on Slideshare
I prepared a quick presentation for you on the Medical Device Classification EU. You can go through it directly on the window below or you can download it.
I uploaded in on my Slideshare account. You can follow me to see all my new contents.
Some last actions for you
One last action for you. Pass the QUIZ and show me that you have learned something.
Did you liked this Tutorial.
Please leave a quick comment and tell me if there is something that I have to improve or to add.
Quizz: EU Medical Device Classification
Take this challenge to see if you have understood everything on the EU MDR Medical Device Classification.
If you reach 80% then I consider that you are fine.
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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 info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
