Software as a medical device (SaMD) refers to a class of medical software that performs one or more medical tasks independently of a physical medical device. It can interface with other medical equipment or software or be utilised with non-medical computer platforms like smartphones. It may be used for a number of objectives, including illness detection, diagnosis, treatment, or prevention. The quality of life for patients and providers can be enhanced through its interactions with data. Regulation is necessary for SaMD since it is a novel and creative technology that must be safe.
Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across...
All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device's specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan,...
Medical devices and the software of those devices are connected to several types of networks. Therefore, it is particularly important for manufacturers to consider Cybersecurity at the initial stages of the development.
Cybersecurity for Medical devices is advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. With the advancement of software as a medical device, proper regulations must establish the safety and security of medical devices.
IMDRF Regulation on SaMD: As more businesses see the benefits of utilizing their software development knowledge for the benefit of patients throughout the world, the market for software as a medical device (SaMD) is expanding quickly.
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
Medical devices that conform to regulations require a conformity marking. Exceptional use medical devices are those that do not comply with regulations of a particular country and do not require a conformity mark. These medical devices may not conform to applicable regulations, but they could still potentially protect patient health.