CE Marking Software

CE Marking Software For Medical Device

CE Marking Software used in medical settings that collect data on patients’ health and helps healthcare providers in their medical practices. CE marking software plays a vital role in diagnosing, treating, and testing various medical conditions. The software can be fitted into a device to enhance its functioning or drive it to perform its function accurately. However, there is another category of medical software called “Software as a medical device (SaMD)”.

SaMD is software that performs one or more medical functions without interfacing with other medical devices and works as standalone software. These are the medical software to be used for medical purposes without being integrated into an actual device. Hence, it is clear that SaMD is not software that supports the functioning of medical device hardware.

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A few examples are listed below to make a clear understanding of SaMD:

• Software to determine a fixed drug dose for a patient based on personalized patient data.
• Software that can analyze medical reports to diagnose a specific medical condition. e.g., diagnosing a stroke by analyzing MRI images.
• Software that can detect cancer through image processing. e.g., tracking a mole’s size and determining the risk for melanoma.
• Software that uses data from other digital devices and determines risk factors associated with epileptic seizures.
• A Software application that calculates insulin dosage based on the glucose level.
• A Software that calculates breathing rate during sleep with the help of a smartphone.

A CE Marking Software is defined as a “SOFTWARE SYSTEM that has been developed to be incorporated into the MEDICAL DEVICE being developed, or that is intended for use as a MEDICAL DEVICE in its own right” according to clause 3.12 of IEC 62304:2015. Organizations must establish documented procedures for the validation of computer software used in production, according to ISO 13485.

Before initial use, MUST confirm the intended application of computer software in monitoring and measuring devices. IEC 62304:2015 or ISO 62304 is the new Medical Device software validation method (life cycle process model) developed. The new standard addresses software development and maintenance, ISO 14971 risk management, software partitioning, safety classification, and software process management.

Stricter rules under new MDR for SaMD

Mobile apps that monitor health conditions such as diabetes, heart disease, depression, etc., are increasing. Worldwide manufacturers of such digital health equipment 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.

With a mandatory compliance date of 26 May 2020, the new EU MDR 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 before any commercial distribution to determine where they fall into the following definition of a ‘medical device’ under the new MDR.

Article (1) states that general-purpose software without a medical purpose and fitness and wellness apps are 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 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.

CE Marking  Software and Role of Consultants

CE Marking Software developers for digital health applications must carefully examine new MDR requirements before commercial distribution to determine where their software falls into the definition of ‘medical device’ within the new EU regulation. This is critical to be meet the mandatory compliance date of 26 May 2020 for software products.

MEDDEVICECORP Regulatory Experts welcome the opportunity to discuss the EU’s MDR’s potential impact on your medical device digital software technology, and more importantly, the steps your organization can take to streamline preparedness activities.

Standalone software shall be classed as an AIMD/ IVD or an accessory to an AIMD/ IVD provided that it meets the definition contained in the relevant Directive.