When is software a medical device?

In medical technology, there is often uncertainty as to whether software should be classified as a medical device or not. For early-stage start-ups, it is essential to understand the criteria and regulations that influence this decision. This blog post provides an overview of the most important aspects of classifying software as a medical device and helps you to classify your service or product correctly and develop it in compliance with german regulations.

What is a medical device?

According to Section 3 No. 1 of the German Medical Devices Act (MPG – Medizinproduktegesetz), standalone software, such as a smartphone app, can be classified as a medical device. This is the case if the software is intended by the manufacturer to be used by humans for at least one of the following purposes

1. Detection, prevention, monitoring, treatment or alleviation of disease
2. Detection, monitoring, treatment, alleviation or compensation of injuries or disabilities
3. Examination, replacement or modification of the anatomical structure or a physiological process
4. Birth control

Indications for classification

If your software provides functions that go beyond mere knowledge transfer and actively act on data or information, it could be considered an active therapeutic or active diagnostic medical device. Here are some key terms and functions that could indicate such a classification:

• Key terms: alert, analyze, calculate, detect, diagnose, interpret, convert, measure, control, monitor, amplify
• Key functions: Decision support or independent decision-making (e.g. for therapeutic measures), calculation of medication dosages, monitoring of patients and data collection to influence diagnosis or therapy

Pure data storage, archiving, lossless compression, communication or simple searching, on the other hand, do not lead to classification as a medical device.

Risk classification of software solutions

The classification of software into risk classes is decisive for the further steps in the conformity assessment procedure. Here are some guidelines:

• Class IIa: All active therapeutic products intended to deliver or exchange energy, as long as they do not present a potential hazard.
• Class IIb: Devices for which the delivery or exchange of energy may present a potential hazard, as well as devices for contraception or protection against sexually transmitted diseases.
• Class I: All other devices that are not assigned to a higher risk class.

The requirements for carrying out the conformity assessment procedure and applying the CE-label differ depending on the risk class. While an independent assessment by the manufacturer is often sufficient for Class I products, the involvement of a Notified Body is required for higher risk classes.

Special cases: Telemedical software and hospital information systems

Telemedical software: If software is used for the telemedical observation and assessment of patient data, it may or may not be classified as a medical device depending on its intended purpose. Pure data transfer systems are generally no medical devices, whereas software for diagnostic support (e.g., also in combination with a medical device) can be classified as such.

Hospital information systems (KIS): These systems support patient management and are generally no medical devices, as they are mostly used for data acquisition for patient admission, for appointment scheduling or for insurance and billing purposes.

Picture archiving systems (PACS): If these systems are only used to store or archive images, they are generally no medical devices. However, if they are used to control medical devices or for diagnosis, it indicates that they are medical devices.

Conclusion

For start-ups in the medical technology sector, it is essential to know the criteria and regulations for classifying software as a medical device. A precise purpose and a review of the functions of your software are crucial to determine the correct classification and associated requirements. With this knowledge, you will be better equipped to bring your innovative solutions to market successfully and in compliance with german regulations.