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SaMD & standalone software CE marking under EU MDR 2017/745
Software CE marking isn’t a single submission. IEC 62304 covers the software lifecycle. ISO 14971 covers risk management. Cybersecurity, usability, clinical evaluation, and post-market surveillance each sit alongside those, each with its own documentation trail. The technical file has to hold all of it together and most submissions hit trouble there, usually because the risk management output doesn’t connect cleanly to the clinical evidence.
Worth pausing on the scope before any of that, though. SaMD covers standalone software performing a medical function such as diagnosis, monitoring, treatment support, prevention running on ordinary hardware. Phones, laptops, cloud. No physical device embedded. What qualifies isn’t obvious from the name: Clinical Decision Support Systems, Radiology Information Systems, Electronic Prescription platforms, and Laboratory Information Systems can all fall in, depending on what the software actually does with clinical data.
EU MDR 2017/745 added prediction and prognosis to the definition of medical purpose.
Trusted Software Medical Device Consultants, the best fit for SAMD teams across Europe, North America and Asia from classification to CE certificatION.” Start your MDR software project →
Who we help with Software CE Marking
I3CGLOBAL supports software developers, startups, healthcare technology companies, and medical device manufacturers seeking CE marking for standalone Software as a Medical Device (SaMD) under EU MDR 2017/745
AI diagnostic software developers
Support for MDR Rule 11 classification, clinical evaluation, IEC 62304 implementation, and AI software technical documentation for EU market entry.
Mobile medical app companies
CE marking support for mobile health applications, telemedicine platforms, and patient monitoring apps under EU MDR 2017/745.
Clinical decision support software manufacturers
Regulatory consulting for CDS software under EU MDR and standalone Software as a Medical Device (SaMD) requirements.
Radiology & imaging AI software
Support for AI-enabled imaging software — cybersecurity documentation, usability engineering, and full MDR technical file preparation.
Cloud-based medical software platforms
Consulting for SaaS medical software platforms — cloud architecture documentation, post-market surveillance (PMS), and ongoing MDR compliance.
Digital therapeutics (DTx)
Regulatory strategy and CE marking support for software-driven therapeutic platforms — from SaMD qualification through to notified body submission.
How I3CGLOBAL assist Software CE Marking?
Standalone medical software sold in the EU is classified as an active medical device under MDR 2017/745. Classification — and the compliance path that follows — depends on the risk to the patient and user. Understanding this before development starts saves significant time and cost.
Classification
MDR Rule 11 — Class I, IIa, IIb, III based on patient risk
IEC 62304
Software lifecycle — safety class A / B / C, development & maintenance
QMS & spec review
Specifications, quality plans, version control procedures, SOPs
Technical documentation
Full tech file — GSPR, design docs, labelling, instructions for use
Risk analysis
ISO 14971 — hazard identification, estimation, controls
Clinical evaluation
CER under MEDDEV 2.7.1 Rev 4 — literature, equivalence, clinical data
Post-market surveillance
PMS plan, PSUR, vigilance reporting, PMCF guidance
Notified body support
Tech file submission, NB query responses, through to CE certificate
Cloud file management
Secure folder, version-controlled tech file maintenance post-certification
Software CE Marking Process Under EU MDR 2017/745
Software CE Marking and IEC 62304
The classification of software under the MDR 2017/745, Annex VIII, Rule 11, and IEC 62304 depends on its intended purpose and potential risks to patients or users. Here’s a general overview of how software is classified:
- Class A: No injury or damage to health is possible.
- Class B: Non-serious injury is possible.
- Class C: Death or serious injury is possible.
It’s very important for manufacturers/software developers to accurately classify their software under the MDR and IEC 62304 as the classification determines the regulatory requirements and conformity assessment procedures that must be followed for technical documentation and notified body application.
In Vitro Diagnostic Software Device
IVD software analyses data from human specimens such as blood, tissue, urine, saliva and produces a result that informs a clinical decision. No patient contact. The analysis happens outside the body; that’s what in vitro means.
Under IVDR 2017/746, Article 2(2) defines an IVD as any device that examines human specimens to provide information on physiological or pathological states, congenital anomalies, treatment compatibility, or treatment monitoring. Software that does any of this independently with no hardware required, falls under that definition.
IVDR 2017/746 treats software as an IVD medical device when it performs a diagnostic function tied to in vitro examination of human specimens. Compared to the old IVDD 98/79/EC, the bar is considerably higher risk-based classification, performance evaluation with clinical data, full lifecycle documentation, cybersecurity requirements, and ongoing post-market surveillance are all now in scope. The clearest cases are software that takes laboratory or genomic data and returns a clinical result are the following
Genomic variant interpretation : analyses sequencing data and classifies variants as pathogenic, likely pathogenic, or benign. Common in oncology and rare disease.
LIMS with analytical functions : reference range comparison, result calculation, abnormal value flagging. Pure storage and forwarding doesn’t qualify. Interpretation does.
Companion diagnostic software : analyses biomarker data to determine therapy eligibility.
AI pathology image analysis : examines digitised tissue samples and outputs a diagnostic result or risk score.
Point-of-care result interpretation : takes raw signal from a lateral flow assay or glucose monitor and applies an algorithm to generate the reported result.
Microbiology identification : matches mass spectrometry data from a bacterial culture against a reference database to identify the organism and flag susceptibility patterns.
What does not qualify as medical software or a SAMD
Very common Standalone software’s used in healthcare industry but NOT a Medical Device are the following
Electronic patient record (EPR)
Replaces paper files only. No analysis of patient data for diagnosis, treatment or prevention.
PACS — image archive only
Stores and displays images only. No manipulation, no radiation guidance, no result comparison.
Administrative software
Scheduling, billing, and workflow support only. No clinical purpose — purely operational or administrative.
Laboratory information system (LIS)
Storage, transport and conversion of lab data only. No analysis of that data performed.
Lifestyle & wellness apps
Monitors, displays or encourages food intake. No medical purpose — general wellbeing use only.
Lab display software
Forwards, saves, converts and displays lab data. No analysis — output only, no clinical interpretation.
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Frequently Asked Questions
Does standalone medical software require CE marking?
What is MDR Rule 11 for software?
MDR Rule 11 is the classification rule under EU MDR 2017/745 Annex VIII that applies specifically to standalone software. It classifies software into four risk classes (I, IIA, IIB & III) based on the potential harm its output could cause to a patient or user.
What is the classification of AI software under MDR?
Do you support IEC 62304? What is the timeframe for the Implementation?
Can mobile apps qualify as medical devices?
Do you provide Software Clinical Evaluation Service as part of Technical Documentation?
Is software running on a medical device considered an accessory?
Software may be regarded as a medical device accessory if it acts as an addition to a particular configuration. For instance, if the software is designed for a specific medical procedure or to serve a particular function of a medical device, such as a web application for configuring the device, it may, but is not required to, be considered a medical device accessory. Firmware is not considered a medical device accessory. Software must be externally integrated with an independently functioning medical device to qualify as a medical device accessory.
Is it possible that a medical device and software have different classes?
Yes, a class III medical device that has the highest risk level can be supported by software that includes only simple, basic functionalities, doesn’t impose any risk, and therefore qualifies for a lower class A or B as per IEC 62304
Page updated by Sara Moly on 20th May 2026 and approved by Sakthileela