Software CE Marking

Standalone Software CE Marking for Medical Device

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.

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. Worldwide 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 MedDeviceCorp 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 their 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.

MedDeviceCorp'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.

More information about Technical File Prepration >>

More information about MDR CE Marking approval Process >>

Software CE Marking Timeline >>

MedDeviceCorp can assist Medical Device Software CE Marking under the latest regulatory EU Medical Device Regulation requirments.

Consultants Role in CE Marking >>


Software CE Marking

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 permanent 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 demonstrating the clinical effectiveness of the Medical standalone software.

    Sometimes the standalone software falls in Borderline cases, reason could be it intended use for general wellness purposes and also for the treatment.

    Non-Medical : Mobile app claims that it records and computes statistics about what the user eats and the quantities of carbs, fat, etc. It is for general wellness purposes.

    Medical : Mobile app claims that it records and computes statistics about what the user eats and the quantities of carbs, fat, for diabetes management. It is for management of diabetes - an aid to the treatment of a disease.

    Embedded software", Firmware",Micro-code software that drive or control the motors and the pumping of medication in an infusion pump or control in an implantable pacemaker

    Software made for an hardware medical device to perform the hardware medical device intended use

    Software that encrypts data for transmission from a medical device

    Clinical communication and workflow including patient registration, scheduling visits and communication

    Administrative support software

    General lifestyle wellness apps

    Electronic patient records

    Software that analyses laboratory quality data to identify errors or trends in calibration

    Software that provides parameters that become the input for software as a medical device

    Intended to diagnose a condition using a digital camera

    MRI and other types of medical imaging to be viewed on regular mobile devices

    Performs image processing in to detect cancer

    Treatment planning

    Regulates an installed medical device

    BMI and body fat calculators


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