Keeping up with MDR for Software

MDR for Software made easy. Everything You Need to Know!

5 min readMay 4, 2023

As technology advances at an unprecedented pace, the development of software as a medical device (SaMD) is on the rise. SaMD offers exciting opportunities for healthcare professionals to diagnose and treat patients more accurately and efficiently.

However, with the ability to introduce innovative products comes the responsibility of complying with medical device regulations to ensure patient safety and efficacy. In this blog, we will explore the European Union’s Medical Device Regulation (MDR) and how it applies to software medical devices.

In this blog we will deep dive into:

How MDR defines software
Software categories in healthcare technology
Explain classes (defined by MDR) using examples from software medical devices
Other parameters that impact medical device classification.

Want to find out how to classify your medical device? Read my blog “Navigating MDR: A Guide to Classifying Your Medical Device”

MDR definition of “software”

The MDR provides guidance on the definition of software as follows:

Software is considered to be a medical device when it is intended to be used for one or more medical purposes, as defined in the MDR.
Software is also considered to be a medical device when it is specifically intended by the manufacturer to be used for diagnostic or therapeutic purposes, regardless of whether it is used on its own or in combination with other products or equipment.
Software that is not intended to be used for medical purposes, such as administrative or financial software, is not considered to be a medical device under the MDR.

Medical Software Categories

In general, medical device software falls into 3 different categories:

Software as a Medical Device (SaMD): This refers to software that is intended to be used for a medical purpose without being part of a hardware medical device. The MDR regulates SaMD as medical devices, and SaMD is classified based on its intended use and level of risk.
Software in a Medical Device (SiMD): This refers to software that is an integral part of a hardware medical device. The MDR regulates SiMD as part of the medical device, and it is not classified separately from the device itself.
Software as an Accessory to a Medical Device: This refers to software that is intended to be used with a hardware medical device to enable its proper functioning or to achieve the device’s intended purpose. The MDR regulates software accessories as part of the medical device and classifies them based on the device they are intended to be used with.

Understanding the Classes

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

1. Class I

This class is considered low risk. That means the device poses almost no risk to patient safety. It’s the easiest level when it comes to MDR certification. At this level, self certification is possible. You will have to comply with all requirements and sign to declare conformity.

Class I example: Software that provides basic clinical information to healthcare professionals, such as a simple calculator for body mass index (BMI) or a calendar for tracking menstrual cycles, may be classified as Class I under the MDR. These types of software are considered low-risk because they do not directly impact patient health and are not used to make clinical decisions.

Class I medical devices can be further subdivided into 3 sub-classes.

The Sub-classes of Class I

Medical devices that fall into these subclasses would need to be partially certified. So, what does this mean? It means that the Notified body is not certifying the full project, it’s just certifying the functions (sterilization, measuring function or reprocessed) which is applicable for your device. For example for Class 1m the notified body review of measuring aspects of the medical device only

The subclasses with examples from software are as follows:

Class Is (Sterile)- Examples of software that may be classified as Class Is (low-risk software that is used in conjunction with a medical device) include software used to control or monitor a medical device, such as a remote control app for a hearing aid or software that helps adjust the settings on a prosthetic limb.
Class I m (Measuring function): Software that is intended to provide information to healthcare professionals to aid in the diagnosis or treatment of a medical condition, but that does not directly provide clinical recommendations, may be classified as Class I m. For example, software that provides anatomical images or educational materials to help a healthcare professional identify potential issues during a physical exam could be classified as Class I m
Class I r (Reprocessed)- Software that is intended for general health and wellness purposes, such as fitness tracking apps or meditation apps, may be classified as Class I r. These types of software are not specifically intended for medical use, but rather to promote a healthy lifestyle and are considered low-risk

3. Class II and Class III

Software examples for Class II and III are as follows.

Class IIa- (medium risk) Diagnostic software that analyzes medical images to assist with clinical decision-making, such as software used in radiology or dermatology. Requires regular assessment by a notified body.
Class IIb- (medium/high risk) Software used in life-supporting or life-sustaining medical devices, such as software used in infusion pumps or ventilators. Mandated regular conformity assessments with notified bodies.
Class III -(high risk) Includes machinery that is important to patient health or to sustaining the life of a patient. Such as software used in implantable or high-risk medical devices, such as software used in pacemakers or artificial heart. Mandated regular conformity assessments with notified bodies.

As medical devices that fall into Classes II- III range from medium to high risk products, medical device and process will need to be fully certified.

You would need help from the Notification Body to help you demonstrate full compliance by conducting technical documentation review, QMS audits, testing and also certifications.

Important: It’s important to note that the classification of a software device under the MDR is based on its intended purpose and level of risk, and can vary depending on the specific features and functions of the software. It’s always best to consult with a regulatory expert to determine the correct classification for a particular software device.

Further parameters that drives classification

In order to help with classification of the medical device, the following are parameters need to be considered:

How long the device is in contact with the patient. Also called duration: Device is used less than 60 minutes then its Transient use. Device is used between 60 minutes and 30 days its Short term Use. Device is used more than 30 days, its Long term use.
If the device is invasive or not.
If the product is active or not.