Medical Device Software Validation Reports (Samd & Simd)
Software CE Marking
Software Medical Device refers to any software designed for diagnosing, treating, monitoring, or preventing diseases or other medical conditions. These devices range from simple applications managing patient data to complex algorithms for analyzing medical images or providing clinical decision support. To comply with European regulatory requirements, obtaining a CE marking for software medical devices is mandatory.
Software CE Marking is essential for all standalone software developed for medical purposes or software intended to enhance healthcare delivery. This includes standalone software that operates independently from hardware medical devices, known as Software as a Medical Device (SaMD).
Software as a Medical Device (SaMD) encompasses all software intended for medical purposes without being embedded in hardware. SaMD includes standalone software products that perform functions such as diagnosing, monitoring, treating, or preventing diseases or conditions. It operates on general-purpose computing platforms like desktops, laptops, tablets, and smartphones, independently of specific hardware. Common examples of SaMD include:
Clinical Information Systems (CIS)
Electronic Prescription (EP) Systems
Clinical Decision Support Systems (CDSS)
Radiology Information Systems (RIS)
Laboratory Information Systems (LIS)
For Software CE Marking, the Medical Device Regulation (MDR) introduces new requirements compared to the previous Medical Device Directive (MDD), including terms such as “prediction” and “prognosis” of diseases. Key to the development and maintenance of medical device software is the application of IEC 62304, which pertains to:
Standalone medical device software
Software that acts as an accessory or component of a medical device
Software used in the production of medical devices
Software Classification as per IEC 62304
The classification of software under MDR 2017/745, Annex VIII, Rule 11, and IEC 62304 is based on its intended use and potential risks to patients or users. Here’s a general overview of software classification:
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.
Accurate classification of software under the MDR and IEC 62304 is crucial, as it determines the regulatory requirements and conformity assessment procedures necessary for technical documentation and notified body application.
How Iqzyme Assists with CE Certification of Software
Iqzyme leverages its MDR regulatory expertise and documentation experience to guide medical software developers through the CE Marking process. Our services include:
Device Classification: Identifying IEC 62304 requirements and software risk class.
Technical Documentation: Comprehensive preparation and management.
Risk Analysis Support: Detailed risk assessment and mitigation strategies.
Review of Specifications: Evaluation of quality plans, software version controls, and procedures.
Post-Market Surveillance Guidance: Support for ongoing market monitoring.
Post-Market Clinical Follow-Up Guidance: Assistance with clinical data collection and analysis.
Periodic Safety Update Report (PSUR) Guidance: Preparation and updates for safety reporting.
MEDDEV 2.7.1 Rev 4 Documentation and Guidance: Compliance with updated clinical evaluation guidelines.
Notified Body Technical File Submission: Submission preparation and response to review comments until CE Certification is achieved.
Maintenance of Technical Files: Secured in cloud storage with version control.
Developers of digital standalone software must adhere to MDR requirements before market release if it qualifies as a ‘medical device’. The Iqzyme team of regulatory experts helps clients globally streamline the complex MDR CE Certification process, offering efficient, cost-effective solutions. For standalone software CE Marking, understanding EU MDR, UK MDR, and MDD is essential, as software used for medical purposes is considered an active medical device. The classification depends on the risk to patients and users.
What Does Not Qualify as Medical Software?
Certain standalone software used in the healthcare industry does not qualify as a medical device under the current regulations. Here are common examples of such software:
Electronic Patient Record (EPR) Systems: These systems are used to replace paper files but are not designed for the analysis of patient records or medical image data for diagnosis, cure, mitigation, prevention, or treatment.
Picture Archiving and Communication Systems (PACS): PACS that merely display and save images without additional features such as informing further radiation treatments, image manipulation, or result comparison.
Administrative Support and Service Software: Software used for administrative purposes and operational support within healthcare settings.
Laboratory Information Systems (LIS): When used solely for administrative support, data storage, transport, and conversion of laboratory data without analyzing the data..
Lifestyle Support Software: Software that monitors, displays, encourages, and warns about lifestyle factors such as food intake but does not provide medical analysis or diagnosis.
Laboratory Display Software: Software used only to forward, save, convert, and display laboratory data without performing any data analysis.
