EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?

If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that.
As we discussed recently, the companies involved in manufacturing and getting medical devices to the EU market face very specific responsibilities due to the EU MDR changes that have taken effect in mid-2021.

Let’s look at what EU Medical Device Regulation 2017/745 considers a ‘medical’ product.

1. First, what is the intended purpose of your product?

As written in the MDR: 

‘Intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation

What does this mean in simple terms?

Basically, you need to respond to these questions:

• What problem do you intend to address? What disease, for example? And what are the contraindications?
• How (at a high level) will your device be used, in your plans? Is it invasive? Is it single use? Should it be sterile? How to clean/disinfect it? How long should it be used? Any requirement about the place where it is to be used?
• Are the steps and general instructions to use it clearly described? 
• What is the intended patient population (age, sex…)? For example, on adults and children older than 15.
• Who will use the product? The patient him/herself? Another person? Can it be a “lay person” (who has no specific training or competence in that subject matter)?
• What is the intended performance of the device, in measurable terms?
• What are the claims of the product? What benefits do you communicate? This is related to the brochure on the Instruction For Use (IFE).

Once all this is clear, it will help you respond to the next question: does your product fall under the definition of “medical”?

2. What is the definition of a ‘medical device’ in the EU?

Article 2 of the MDR gives us an important definition that is rather broad:

‘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. 

From there, hopefully, you can respond to the question “is our device considered medical?”:

• Maybe it can be used in a medical setting, but your instructions make it clear that it is to be used only in a non-medical setting – for example, you import a scalpel in the EU and it is clearly labeled “only for users in a laboratory for cutting non-live tissue”;
• Maybe it is pharmaceutical, not medical;
• Maybe it is clearly medical.

Do you see how defining your intended purpose first made this easier?

In case of doubt, you can contact the market surveillance authorities in your country, as they may be able to point you in the right direction. Or you can search for a notified body and ask them directly.

3. what is the class of your device?

Class I devices carry much less risk than class IIb and class III devices. The path to certification under the EU MDR is much easier for a class I device. So, this is quite an important question.

The amount of involvement of a notified body varies along with the risk:

• Lowest risk: class I: self-certification (no need for a notified body to be involved)
• Higher risk: class Im (measurable), Ir (reusable), Is (sterile): partial certification by a notified body
• Highest risk: class IIa, IIb, and III: full certification by a notified body

The classification of medical devices is based on criteria such as:

• Duration of contact with the patient
• Degree of invasiveness
• The part of the body affected by use of the device

The EU MDR changes include 22 rules for classifying MDs.

Some key definitions that are useful for classifying a MD are in annex VIII and in chapter 1 of the EU MDR. 

Some abridged definitions are reproduced below:

• Duration: “transient” is for continuous use of less than 60 min (e.g. a stethoscope) vs. “long term” is more than 30 days (e.g. eyewear)
• Invasive: has to penetrate the body
• Active: works on a source of power different from that generated by the human body or gravity, and acts by converting that energy (e.g. muscle stimulator)
• Body orifice: any natural opening or permanent artificial opening
• Surgical invasive device: penetrates through the surface of the body, or produces penetration other than through a body orifice
• Re-usable surgical instrument: an instrument that is used in cutting, drilling, etc. without being connected to an active device, and intended to be reused after certain appropriate procedures
• Active therapeutic device: supports, modifies, replaces, or restores biological functions or structures (e.g. an external defibrillator)
• Active device intended for diagnosis and monitoring: used to supply information for detecting, diagnosing, monitoring, or treating physiological conditions or illnesses 
• Continuous use: uninterrupted use, or interrupted while a similar device is installed.
• Intended use is based on the data supplied by the manufacturer of labelling or in the instructions and/or promotional materials

Here are some important points to keep in mind:

• If the device works with other devices, each of them should be classified separately
• Software that drives a certain device needs to be in the class of that device. (Follow the highest risk represented by the whole device.)

Understanding the EU MDR changes and figuring out what class a medical device is can be a complicated task. This guidance document can help you find out and if you’re dealing with a more ‘borderline’ device type then check this guide about borderline cases.

Read and listen to more about the EU MDR

Explore these resources about the EU MDR changes, how you’re affected, and how to classify your medical devices and get them certified:

• How The EU MDR Will Change The Medical Device Industry Forever [Podcast]
• New EU MDR: Who Are The “Economic Operators” For Imported Devices?
• EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]

A disclaimer…

We at Sofeast are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.