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MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

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Software CE Marking

Software CE Marking

A software medical device refers to any software intended for use in the diagnosis, treatment, monitoring, or prevention of disease or other medical conditions. These devices can range from simple applications for managing patient data to complex algorithms for analyzing medical images or providing clinical decision support. To comply with European regulatory requirements and market software devices CE marking is mandatory.


Software CE Marking is mandatory for all standalone software developed with the intent of medical purposes only or in other way, software used for improving the healthcare delivery process is considered Medical Standalone Software.

Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) refers to all types of software intended to be used for medical purposes without installing in a hardware medical device. It’s a standalone software product that performs medical functions such as diagnosing, monitoring, treating, or preventing diseases or medical conditions. SaMD operates on general-purpose computing platforms such as desktops, laptops, iPads and mobiles and can be used independently of any specific hardware device. A few very common medical standalone software are the following:


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


For Software CE Marking, the new Medical Device Regulation (MDR) is slightly different from the earlier Medical Device Directive (MDD) with the inclusion of the terms “prediction and prognosis” of a disease. Application and significance of IEC 62304 in the development and maintenance of medical device software is when:


  • Standalone medical device software
  • Software which is an accessory/component of a medical devices
  • Software used in medical device production

I3CGLOBAL and their professionals are qualified and experienced to take-up any risk class MDR Software projects from any part of the world. 

Software Classification as per 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.

How I3CGLOBAL assist CE Certification of Software?

I3CGLOBAL offers its MDR regulatory expertise and Documentation experience to guide medical software developers through the CE Marking process. This assistance may involve:


  • Device Classification, IEC 62304 requirement Identification and identification of software risk class
  • Technical Documentation
  • Risk Analysis Support
  • Review of specifications, quality plans, software versions controls, and procedures.
  • Post Market Surveillance guidance and support
  • Post Market Clinical Follow-up guidance
  • Periodic Safety Update Report Guidance
  • MEDDEV 2.7.1 Rev 4 documentation and guidance
  • Notified Body Technical File submission and answering to review comments till CE Certification
  • Maintenance of Technical files in a secure folder in the cloud with version control

Developers of digital standalone software must understand and follow the new MDR requirements before releasing them into the EU market if it falls under the definition of ‘medical device’.


The I3CGLOBAL team of regulatory experts supports clients across the globe by streamlining the complex MDR CE Certification process and by providing economic and time-saving solutions. Those planning for standalone Software CE Marking must know EU MDD/MDR and UK MDR, consider such software used for medical purposes is considered to be an active medical device. The classification depends on the risk to the patient and users.

What does not qualify as medical software?

Very common Standalone software’s used in healthcare industry but NOT a Medical Device are:

  • An Electronic Patient Record (EPR) system, only replaces paper files but is not intended for the analysis of patient records, or patient medical image data, for the diagnosis, cure, mitigation, prevention, or treatment.
  • Picture Archiving and Communication System (PACS), which only shows and saves pictures with NO additional features such as informing further radiation treatments, Image manipulation, and result comparison.
  • Administrative support and service software
  • Laboratory information systems (as long as it is only used for administrative support, storage, transport and conversion of laboratory data)
  • Lifestyle support software which monitors, displays, encourages and warns food intake
  • Laboratory display software is only used to forward, save, convert and display laboratory data and NOT analyse the data.

I3CGLOBAL and their professionals are qualified and experienced to take-up any risk class MDR Software projects from any part of the world. 
Frequently Asked Questions

Do you support IEC 62304? What is the timeframe for the Implementation?

Yes we support IEC 62304 Implementation. The average timeline for the proper implementation is 3-4 months.

Do you provide Software Clinical Evaluation Service as part of Technical Documentation?

We provide Clinical Evaluation Report documentation service for Software medical devices.