Is your software a medical device or an accessory? Understanding EU MDR classification
Is my software a medical device in the EU?
Software is considered a medical device in the European Union if it meets the definition provided in the EU Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746:
- Intended Purpose
Software is considered a medical device if it is intended by the manufacturer to be used for:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation, or compensation of an injury or disability.
- Investigation, replacement, or modification of the anatomy or a physiological process.
- Control or provision of information for conception.
- Providing information derived from in vitro diagnostic data for medical purposes.
- Direct or Indirect Medical Purpose
Software does not need to have a direct therapeutic effect to be considered a medical device. It can analyze data, provide diagnostics, or suggest treatment based on clinical information.
- Standalone Software
Standalone software can qualify as a medical device if it is specifically intended for medical purposes. For example:
- A diagnostic imaging application for analyzing X-rays.
- A diabetes management app used to calculate insulin doses.
- Software interpreting electrocardiograms (ECG) to diagnose arrhythmias or other cardiac conditions.
- Apps designed to calculate insulin doses based on user-entered glucose levels.
- Applications that use patient data to predict disease progression or treatment outcomes.
- ...
Classification under MDR/IVDR:
Medical Device Software (MDSW) is classified under the MDR or IVDR based on the intended purpose and associated risks.
MDSW Classification under MDR
Under MDR MDSW is categorized according to the rules for medical devices, considering its impact on patient safety. For example:
- Class I: Software with minimal risk, like general health management apps.
- Class IIa/IIb: Diagnostic or monitoring software influencing clinical decisions.
- Class III: High-risk software used in critical healthcare decisions, such as diagnosing life-threatening conditions.
MDSW Classification under IVDR
Under IVDR, MDSW used for in vitro diagnostics is classified using a risk-based approach:
- Class A: Low-risk software, like data storage applications.
- Class B/C: Moderate-to-high-risk software, such as apps analyzing diagnostic data.
- Class D: Software supporting critical diagnostics, like blood typing or detecting infectious diseases.
Proper classification ensures compliance with regulatory requirements and helps manufacturers define the appropriate conformity assessment procedures.
When Software is Not a Medical Device
Some software can be interpreted as either MDSW or not, depending on its intended purpose and functionality. If the software is designed to diagnose, monitor, or influence medical decisions, it qualifies as MDSW under EU MDR or IVDR. However, general-purpose software, such as administrative tools or fitness trackers, is typically not classified as MDSW. The distinction hinges on whether the software serves a direct or indirect medical purpose.
Here are examples of software that is not classified as Medical Device Software:
- General-purpose software without a medical intent (e.g., fitness trackers or general health apps not intended for medical use).
- Administrative software used for healthcare facility management.
- Software for patient scheduling or medical billing.
- Educational tools for healthcare professionals.
- Data storage or transfer tools that do not analyze or process medical data.
Software as an Accessory to a Medical Device
Software is considered an accessory to a medical device in the European Union when it is not a medical device itself but is intended by its manufacturer to support, enhance, or enable the functionality of a medical device in accordance with MDR or IVDR.
An accessory to a medical device is an item:
- Specifically intended by the manufacturer to be used together with a medical device.
- Enables the device to be used according to its intended purpose or assists the medical device in fulfilling its intended purpose.
Key Criteria for Software as an Accessory
Intended Use
The software must be designed to assist a specific medical device in achieving its medical purpose. It does not directly diagnose, treat, or monitor a patient but helps the medical device perform these tasks.
Dependence on a Medical Device
The software’s purpose is intrinsically linked to the medical device. It is not standalone software with a direct medical function but complements the device's capabilities.
Role in Enhancing Functionality
It may improve the performance, accuracy, usability, or safety of a medical device without independently meeting the definition of a medical device.
Examples of Software as an Accessory
- Software for calibrating or controlling a diagnostic device (e.g., software used to configure an imaging system).
- Software that interfaces with medical devices to collect and transfer data without performing analysis or medical functions (e.g., software transferring data from a wearable heart monitor to a healthcare professional).
- Mobile apps used to control a medical device remotely (e.g., apps for controlling an insulin pump or hearing aid).
- Data visualization tools designed to display output from a medical device for ease of interpretation by clinicians.
