Software CE Marking and FDA 510k

Medical Device Standalone Software CE Marking

As per clause 3.12 of IEC 62304:2015 a Medical Device Software means “SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right”

ISO 13485 requires that organizations establish documented procedures for the validation of the computer software used in production. The intended application of computer software in monitoring and measuring devices must be confirmed before initial use.

The new Medical Device software validation method (life cycle process model) developed is known as IEC 62304:2015 or ISO 62304. The new standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management.

The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute.

Software CE Marking depends on the type and risk class of the software in question. The software safety classes shall initially be assigned based on severity as follows:

  1. Class A: No injury or damage to health is possible
  2. Class B: Non-SERIOUS INJURY is possible
  3. Class C: Death or SERIOUS INJURY is possible

The software needs to classify as per Medical Device Regulation. The class of medical software can be easily found out if it is used in connection with other Medical Equipment. If it is used as a standalone equipment based on the Risk analysis and Indended application the class can be found out

Stricter rules covered under new MDR for Medical Software

Mobile apps that monitor health conditions such as diabetes, heart disease and depression etc are increasing now. World wide manufacturers of such digital health equipments, must carefully consider the new rules and regulatory requirements set forth within the Medical Devices Regulation (MDR), adopted by the European Parliament and Council in May 2017.

The new EU MDR, with a mandatory compliance date of 26 May 2020, replaces the former Medical Device Directive (MDD), and introduces new concepts, definitions, classification rules and procedural requirements for medical device software. Many digital health care products will now fall into the scope of the new European MDR.

Manufacturers of digital products must carefully examine new MDR requirements for CE Marking prior to any type of commercial distribution to determine where they fall into the following definition of a ‘medical device’ under the new MDR..

General purpose software without a medical purpose as defined in Article (1), as well as fitness and wellness apps, from being regulated as medical devices.

In addition, all software developers must consider the implications of the General Data Protection Regulation (GDPR), which will apply in the EU from 25 May 2018, and will replace the current EU Data Protection Directive. The GDPR will introduce new EU data protection requirements with increasing responsibility and liability of entities processing personal health data collected via software of individuals in the EU.

How can I 3 CONSULTING help in Software CE Marking?

Medical Software developers for digital health applications must carefully examine new MDR requirements prior to commercial distribution to determine where there software fall into the definition of ‘medical device’ within the new EU regulation. This is critical in order to be meet the mandatory compliance date of 26 May 2020 for software products.

I 3 CONSULTING's global regulatory experts welcome the opportunity to discuss with you the potential impact of the EU’s MDR on your medical device digital software technology, and more importantly, the steps your organization can take to streamline preparedness activities.

I 3 CONSULTING can assist Medical Device Software CE Marking under the latest regulatory EU Medical Device Regulation requirments.


The MDR provides a clear definition in Article 1:

  • software in its own right, when specifically intended by the to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not.
  • advanced digital software algorithms and self-learning neuronal networks that predict or provide a form of prognosis of a future state of health from a collective of patient data are Class I Medical Software Devices? Unfortunately, Rule 11.

    Intended Purpose for diagnostic purposes.

    Intended Purpose for therapeutic purposes.

    Monitoring of physiological processes.

    Intended for Documentation Purposes Only.

    Intended For Research and Education.

    Not specifically intended for a medical purpose.

    Software(s) are divided into standalone and embedded mainly.

    Embedded software integrated into a medical devices, such as used in blood pressure monitor or an MRI scanner.

    Standalone software is independent of any other device and influence the functioning / use of other medical devices or could be used in combination with other Medical Devices, such as an electronic prescription software or software incoming data leads to an alarm function on th device.

    Rule 11 (MDR): Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:.

    - death or an permenenet injury of a person’s state of health, in which case it is in class III; or

    - a serious injury of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

    If the organization Implemented EN ISO 13485:2016 & IEC 62304 strongly, the CE Certification may take approximately 6-8 months after the submission of Technical File to Notified Body.

    As per new MDR, Software (SaMd) CE Marking Clinical Evaluation, PMS, PMCF is highly recommended to demonstrate the clinical effectiveness of the Medical standalone software.




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