Software CE Marking Overview

Software medical devices include any software designed for use in the diagnosis, treatment, monitoring, or prevention of diseases or other medical conditions. These can range from simple patient data management apps to advanced clinical decision support systems and medical image analysis tools.

Why Is CE Marking Important for Software?

To legally market software as a medical device within the European Union, CE marking is mandatory. This ensures the software meets essential safety, performance, and regulatory requirements outlined under the EU Medical Device Regulation (MDR) and IVDR where applicable.

Types of Software Devices for Medical Purposes

Software as a Medical Device (SaMD) is defined as software intended for medical use without being part of a physical medical device. These standalone applications carry out key medical functions—such as diagnosis, monitoring, treatment, or prevention—on general-purpose platforms like desktops, tablets, or smartphones.

Common Examples of SaMD:

Clinical Information Systems (CIS)
Electronic Prescription (EP) Systems
Clinical Decision Support Systems (CDSS)
Radiology Information Systems (RIS)
Laboratory Information Systems (LIS)

These software products are crucial in modern healthcare workflows and require CE Marking under the EU Medical Device Regulation (MDR).

MDR vs. MDD: What Changed?

The Medical Device Regulation (MDR) broadens the definition of medical software by explicitly including functions related to the prediction and prognosis of diseases. This change increases the number of software products that now fall under regulation and require CE certification.

Relevance of IEC 62304:

The IEC 62304 standard plays a critical role in the development and maintenance of medical software, particularly when the software is:

A standalone medical device
An accessory or component of a medical device
Used in the production or quality control of medical devices

Your Trusted Partner in Software CE Marking

Navigating the complexities of MDR software classification and CE certification demands precision, experience, and deep regulatory insight. At I3CGLOBAL, we offer end-to-end support—from risk classification to technical file submission and post-market compliance—ensuring your software meets all EU regulatory standards efficiently and effectively.

Let us help you accelerate your software’s journey to CE Marking—accurately, securely, and globally.

Understanding the Boundaries of Medical Software

Not all software used in healthcare qualifies as a medical device. Recognizing this distinction is essential for ensuring proper regulatory alignment and avoiding unnecessary compliance burdens. At RAPS, we help you differentiate between administrative, lifestyle, and medical-purpose software—ensuring your product is accurately classified and CE-marked only when required.

Clarity in classification leads to confidence in compliance. Let’s get it right—together.

Final Takeaway

Understanding what does not fall under the scope of medical device software is just as important as knowing what does. Misclassification can lead to unnecessary regulatory challenges or compliance gaps. At RAPS, we help you make informed, accurate decisions—ensuring your software meets the right regulatory requirements based on its intended use.

Partner with us to avoid overregulation and stay focused on what truly matters—delivering reliable digital health solutions.

Software CE Marking Overview

Why Is CE Marking Important for Software?

What Qualifies as Medical Software?

Types of Software Devices for Medical Purposes

Types of Software Devices for Medical Purposes

Common Examples of SaMD:

MDR vs. MDD: What Changed?

Relevance of IEC 62304:

Your Trusted Partner in Software CE Marking

Understanding the Boundaries of Medical Software

Final Takeaway

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