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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

Software CE Marking is mandatory for all software developed with the intent of medical purposes, to sell in the European Union.  All software used for improving the healthcare delivery process is considered Medical Standalone Software.

Software as a Medical Device (SaMD)

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 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 a accessory/component of a medical devices
  • Software used in medical device production

MDR Software Classification

As per IEC 62304 and New MDR 2017/745, Annex VIII, Rule 11, the software are classified as follows:


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.


The classification is mainly based on its potential to create a hazard that could result in an injury to the user, the patient, or other people.

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How I3CGLOBAL can help with MDR Software CE Marking?

  • 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, 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 file in secure folder in 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’.


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 purpose is considered to be an active medical device. Classification depends on the risk to the patient and users.

What NOT a Medical Device Software?

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

  • An Electronic Patient Record (EPR) system, which only replaces the paper files but not intended for the analysis of patient records, patient medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment.
  • Picture Archiving and Communication System (PACS), which only shows and saves pictures with NO additional feature such as informing further radiation treatments, Image manipulation, 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 monitor, display, encourage, warns food intake
  • Laboratory display software only used to forward, save, convert and display laboratory data and NOT analyzing the data.