Navigating MDR: A Guide to Classifying Your Medical Device

• Are you creating software applications for the healthcare industry?
• Are you planing to launch your product to the European market?

Then you need to navigate the complex world of the Medical Device Regulation (MDR). The MDR sets safety and performance standards for medical devices sold in the EU, but figuring out the right classification for your device can be tricky.

In this blog, I will guide you through the MDR maze. It will help you understand how to navigate through MDR and help you arrive at the right classification for your device.

Should I be concerned with MDR If I am dealing with software applications built for the healthcare industry?

This is one of the most common questions that many people have. The MDR applies to all medical devices, including software, that are placed on the EU market. Whether your software falls under the definition of a medical device depends on its intended use, risk and the claims made about its medical purpose.

[Learn more about ‘medical software categories’ in my blog: “Keeping up with MDR for Software”]

What guidance does MDR provide for software?

In MDR, software is defined as a set of instructions that processes input data and produces output data. This definition includes standalone software (SaMD- Software as a Medical Device) as well as software that is part of a medical device (SiMD- Software in a Medical Device).

“I want to identify the class of my medical device. What do i need to know?”

To simplify the process, there are 2 areas that you need to understand to identify the class of your medical device. They are:

• Classes
• Rules

Understanding RULES and CLASSES

If you’re medical device needs to complying with MDR, you would first need to identify the class (or classification) of the device. Then you would need to follow the requirements of the class to be MDR compliant.

Hence, MDR has defined a set of Rules. And each rule has a corresponding classification (or class). You find the rule(s) that relate most closely to the purpose of the medical device or application and you will have your class right there!

Sounds simple right? let’s dive a bit deeper.

Let me break it down.

MDR has provided us with a set of 22 RULES.

What are RULES?

Rules refers to the specific requirements and criteria that are used to classify medical devices into different classes based on their level of risk.

To understand this better, lets look at Rule 11 (related to software) defined in MDR:

To make it easy to understand, I have broken down Rule 11 as follows,

For example: medical imaging techniques like MRI or CT help diagnose medical conditions. This is an example of a medical device under Rule 11 of the MDR. Software which provides information to a healthcare professional for making a clinical decision would be classified as Class IIa under the rule 11.

The 22 Rules are spread out across 4 sections. (MDR annexture VIII).

[To find out which section you need to look under, you would have to first define if the medical device you are dealing with is invasive, non-invasive, or active]

• Non invasive device- Rules 1,2,3,4
• Invasive device- Rules 5,6,7,8
• Active device- Rules 9,10,11,12, 13
• Special Rules- Rules 14,15,16,17,18,19, 20, 21, 22

What are the Classes?

All medical devices can be classified to different classes depending on the risk of the device.

Want to learn more about Classes with real world software healthcare examples? Read more about classes in my blog: “Keeping up with MDR for Software”

Lowest class is Class 1. This class poses the least threat to patient safety. The highest class is Class III which is poses the highest risk to patient safety.

Depending on the class of your device, there are different levels of requirements you would need to fulfill to be MDR compliant (less risk then less requirements, more risk then more requirements).

Steps to identify the class of a medical device?

1. Define the main purpose of the medical device or application.
2. Define the duration the device be in contact with the patient (e.g. transient, short term, long term use). Read point 8 & 9 in the guidelines below.
3. Identify what type of device you are dealing with. (eg: non invasive, invasive or active device.)
4. Read the rules related to the type of device.
5. Review the special rules to verify if there are any special rules defined in this section which are applicable to the device.
6. You will arrive at rule(s) which relates closely to your medical device. If multiple rules apply, the class of your medical device would be the rule which has the highest risk.

Guidelines

1. Clearly understand the intended purpose of the medical device.
2. Identify if the device works with other devices. If so, each of them need to be classified separately.
3. If software drives the device, then the software falls into the classification of the device. (eg: if the device is Class IIa then the software is also Class IIa)
4. Software as a medical device is classified on its own. Eg an software application
5. If multiple rules apply to the medical device, it might be hard to define which classification it falls under. At this time, you have to consider the most critical use of the device to determine the classification.
6. If the product has multiple functions and therefore falls under many rules or sub-rules, then the higher classification applies. (eg.: the device has 3 functions and each function falls under different rules, then the highest classification (higher risk) applies.
7. The following needs to be considered for continuous use:
8. The entire duration of use with temporary interruption / renewal. (eg: removing a device or cleaning or maintenance before putting it back on)
9. Accumulated use of a device that needs to be replaced immediately with another of the same type. (eg: removing the device and replacing with another of the same type)

Want to learn more about software medical devices and MDR. checkout my blog “Keeping up with MDR for Software” where i deep dive on this topic