Did you know that under the EU MDR 2017/745, you now have to reclassify your medical device… even though it was previously classified under the old Medical Device Directive (MDD 93/42/EEC)?
If you want to learn about classifying your medical device, then you’ve come to the right place! In this post we’ll be looking at the different risk classes of medical devices, how to classify your medical device under the EU MDR 2017/745 and I’ll be sharing with you a simple gap assessment tool that can help you determine what your new classification will be.
What is the MDR and how are the different risk classes defined?
In Europe, medical devices are regulated by the European Commission. The Regulation that is currently being used to regulate medical devices is the European Union Medical Device Regulation 2017/745, or as it is more commonly referred to, the EU MDR 2017/745 or simply, the MDR.
This regulation now supersedes the Medical Device Directive 93/42/EEC.
In order to obtain a CE mark for a particular medical device, a conformity assessment will need to be conducted. This is usually based on the risk class of the medical device in question.
What are the categories of medical devices?
The EU MDR has 4 main categories when it comes to medical device classification. These are Class I, IIa, IIb and III.
The duration of use and overall definition of the medical device is also important when determining the risk class.
As a start, the duration of use can be broken down into three main groups:
- ‘Transient’ – this means normally intended for continuous use for less than 60 minutes
- ‘Short term’ – this means normally intended for continuous use for between 60 minutes and 30 days
- ‘Long term’ – this means normally intended for continuous use for more than 30 days
These groups of ‘duration of use’ remain the same as the previous Medical Device Directive 93/42/EEC.
Each class of medical device is ranked from the lowest risk (class I) to the highest risk (Class III) with each risk class requiring a different conformity assessment route. This means that depending on your risk class, there be a different defined set of steps that needs to be followed in order to obtain a CE mark.
Now let’s look at the classes in more detail.
Class I medical devices are known as those devices with the lowest risk. Common examples include bandages and glasses. In these cases, manufacturers can self-certify their devices without the involvement of a notified body.
Class I medical devices are then further broken down into three sub-classifications:
- Class Is: The medical device must be presented sterile
- Class Im: The medical device has a measuring feature
- Class Ir: The medical device is a reusable surgical instrument
Class IIa medical devices
Class IIa medical devices are considered medium-risk devices. Common examples include hearing aids and catheters. Unlike Class I devices, the manufacturer must receive approval from a notified body.
Class IIb medical devices
These medical devices are considered to be medium to high-risk devices. Common examples include ventilators and insulin pens. These devices also require the involvement of a notified body to obtain their CE mark.
Class III medical devices
Class III medical devices are considered the highest risk medical devices. These devices often have more regulatory requirements associated with them before obtaining a CE mark such as having a clinical investigation plan and clinical evaluation report. Common examples of class III medical devices include pacemakers and breast implants.
How do you classify your medical device under the EU MDR 2017/745?
The MDR uses a rule-based system for classifying medical devices. These rules are defined in Annex VIII of the MDR 2017/745.
This annex includes 22 rules for classifying medical devices.
The rules are divided into four sections, and the rules of each section apply to a specific category of devices. The rules are set out as follows:
- Rule 1– Non-invasive devices
- Rule 2 – Non-invasive devices intended for channeling or storing
- 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
- 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
There are also 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
The duration of the device’s use is used to determine which rule(s) apply within a given category. The three types of duration specified in the MDR are:
So how do you actually classify your medical device?
To classify your medical device, follow these three critical steps:
STEP 1: Determine which definition your medical device falls under according to the definitions defined in the MDR 2017/745.
STEP 2: Determine which rule applies to your medical device. If there are multiple rules that are applicable, then choose the rule with the highest risk.
STEP 3: Document the applicable rule and justification. This can be done in a simple classification document.
What if my device is a borderline medical device?
If your product is a borderline product (i.e. a mix between a drug and a device), you will need to identify the main intended use before classifying your device as either a medicine or medical device. Then follow the relevant classification rules.
To help you classify your medical device, I’ve created a simple classification gap assessment document. This document breaks down the classification rules clause by clause so you can determine if a particular definition is applicable to your device.
This way, you can easily determine how your device is defined according to the EU MDR 2017/745 and which is the applicable classification rule.