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:
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:
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:
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.
GAMP GROUP 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.
Developers of digital standalone software must adhere to MDR requirements before market release if it qualifies as a ‘medical device’. The GAMP GROUP 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.
GAMP Group has been offering CSV and Data integrity services since last 8 years. GAMP Group has Computer System Validation & DI consultants & engineers who can assess your computer systems compliance assessment or validation against following regulatory and industry standards:
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