Software CE Marking

Medical software is defined as any software intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease or medical conditions. These range from basic patient data management tools to advanced algorithms used for medical image analysis, clinical decision support, and remote monitoring.

Under the Medical Devices Regulation (MDR) 2017/745, software that meets the definition of a medical device must obtain a CE Mark before being placed on the European market. This ensures the software complies with essential safety, performance, and risk management requirements.

What Is Considered Medical Software?

Standalone medical software—also known as Medical Device Software (MDSW)—includes any application developed with a medical purpose, whether it operates independently or alongside other devices or platforms.

Examples include:

Mobile apps used for health condition tracking
Software for diagnostic image analysis
Programs supporting clinical treatment decisions
Digital tools enhancing healthcare delivery processes

If the intended use of the software is medical, it must be CE marked before distribution or commercial use in the EU.

Why It Matters

CE marking validates your software's safety, performance, and regulatory compliance, providing access to the entire European market while building trust with clinicians and patients.

Partner with RAPS for Seamless Software CE Certification

At RAPS, we guide you through every step of the software CE marking process—from classification and conformity assessment to technical documentation and notified body engagement. Whether you're developing AI-powered diagnostics or patient management platforms, we help ensure your software meets all MDR requirements with confidence.

Ready to Bring Your Medical Software to Europe?

Let RAPS help you navigate the path to CE marking success.

Different Types of Software Devices for Medical Purposes

Software as a Medical Device (SaMD) refers to software solutions intended for medical purposes that function independently of physical medical devices. These are standalone software products designed to diagnose, monitor, treat, or prevent diseases and operate on general-purpose platforms such as desktops, laptops, tablets, and smartphones.

Unlike software embedded in or operating hardware medical devices, SaMD is self-contained and performs medical functions on its own.

Common Examples of Medical Standalone Software

Clinical Information Systems (CIS) – Manage and integrate patient health data
Electronic Prescription (EP) Systems – Facilitate digital medication orders and prescriptions
Clinical Decision Support Systems (CDSS) – Provide clinicians with intelligent decision-making tools
Radiology Information Systems (RIS) – Support imaging workflows and data management
Laboratory Information Systems (LIS) – Oversee laboratory data, processes, and reporting

Regulatory Considerations for Medical Software

Under the EU Medical Device Regulation (MDR) 2017/745, the definition of a medical device has been expanded to explicitly include software used for prediction and prognosis of diseases. This broadens the scope of what qualifies as SaMD and requires CE marking for market access in Europe.

Applicability of IEC 62304

The international standard IEC 62304 outlines the software lifecycle processes for medical device software and is essential for:

Standalone SaMD
Software that functions as an accessory or integral component of a medical device
Software used in the design, testing, or production of medical devices

Navigating Software Compliance with RAPS

At RAPS, we help you classify, document, and certify your software solutions—whether they’re standalone medical apps or embedded tools—ensuring full compliance with MDR and international standards like IEC 62304.

Software Classification Under IEC 62304 and MDR

Under the EU MDR 2017/745 (Annex VIII, Rule 11) and IEC 62304, medical software must be classified based on its intended purpose and the potential risk it poses to patients or users. This classification is essential, as it defines the level of regulatory scrutiny and the type of conformity assessment required.

IEC 62304 Software Safety Classes

Class A – The software cannot cause injury or harm to health.
Class B – The software may cause non-serious injury under certain conditions.
Class C – The software could result in death or serious injury if it fails.

Accurate classification is crucial—it directly impacts the regulatory pathway, technical documentation, and whether a Notified Body review is required for CE marking.

How RAPS Supports CE Marking of Medical Software

At RAPS, our regulatory specialists help software developers navigate the complexities of CE certification under MDR and IEC 62304. Our end-to-end support includes:

Software classification in line with MDR Rule 11 and IEC 62304
Identification of applicable conformity assessment procedures
Development and review of complete technical documentation
Comprehensive risk management and analysis support
Guidance on software lifecycle processes and quality documentation
Support for Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF)
Preparation of Periodic Safety Update Reports (PSUR)
Expertise in MEDDEV 2.7.1 Rev 4 for clinical evaluation
Coordination of Notified Body submissions and management of review responses
Secure cloud-based document control and version management

Planning to Market Standalone Medical Software in the EU?

If your software qualifies as a medical device, it must meet the requirements of the EU MDR or UK MDR. Such software is classified as an active medical device, and classification depends on potential risk to the patient and user.

At RAPS, we streamline the CE marking process, offering cost-effective, timely, and globally aligned regulatory solutions. Whether you're a start-up or an established manufacturer, we ensure your software meets all compliance benchmarks before hitting the EU market.

What Does Not Qualify as Medical Software?

Not all software used in healthcare settings falls under the definition of a medical device. According to the EU MDR 2017/745, software is only considered a medical device if it is intended to be used for a specific medical purpose, such as diagnosis, prevention, monitoring, or treatment of a disease.

Many commonly used standalone software tools in the healthcare industry are not classified as medical devices when they do not perform clinical functions or influence clinical decision-making.

Examples of Non-Medical Software in Healthcare

Electronic Patient Record (EPR) Systems
Used for organizing and storing patient data digitally; simply replacing paper files without performing diagnostic or treatment functions.
Picture Archiving and Communication Systems (PACS)
If used solely for image storage and display—without features like diagnostic image manipulation, measurement tools, or comparative analysis—they are not medical devices.
Administrative Software
Tools used for scheduling, billing, resource planning, or general healthcare operations support.
Basic Laboratory Information Systems (LIS)
When limited to data storage, transport, or conversion, and not used for interpreting or analyzing lab results.
Lifestyle and Wellness Apps
Applications that provide general health guidance, track food intake, or promote physical activity without any diagnostic or therapeutic intent.
Laboratory Display Software
Systems that simply forward, store, convert, or display lab data without analyzing or impacting clinical decisions.

Clarify Your Software’s Classification with RAPS

Understanding whether your software qualifies as a medical device under MDR is the first and most important step in determining your regulatory obligations. At RAPS, we help developers assess and document software intent, functionality, and classification to avoid unnecessary regulatory burdens or overlooked compliance risks.