Many different opinions were issued in the meantime, which aim was to define a decision criterion to classify software as medical device or not.
Two kinds of software are related to medical devices: Embedded Software and Stand-Alone Software.
The first one is related to a medical electrical equipment, and it drives the performances, the user interface and the patients interaction, while the second one is related to an application running on general purposes computer systems, such as PCs, Servers, Apps in cloud or mobile systems.
The question about a software being a medical device or not concerns mainly the Stand-Alone software, because the embedded one is essentially a component of the whole electrical medical equipment.
The Stand-Alone Software can include several functions with different aims. Typically, this kind of software, used as IT system in a healthcare facility, can include administrative information as well as clinical data related to all patients, it is used by professionals to take their clinical decisions or to drive the performance of a medical device. For this reason, each module included into a software used in a medical centre, must be individually classified as medical device or not, according to its own indication for use. Thus, it is important to consider that, even if the software is used in a healthcare facility, this does not mean that it is a medical device.
Different criteria from competent Authorities can be found in relevant guidance documents. In October 2019, the EU MDCG group issued the MDCG 2019-11 guidance document, while the International Medical Device Regulatory Forum (IMDRF) published in December 2013 the guidance “Software as Medical Device (SaMD): Key Definitions”.
Both documents state that the criterion to qualify a software as a medical device must be related to the general definition of “medical device” as defined in the relevant regulations. But when the EU guidance states, for example, that a simple recording and retrieval of clinical data doesn’t qualify a software as medical device, other guidance instead considers it as SaMD because it influences a medical decision about the patient treatment.
As usual Medical Device Regulatory Affair is not a simple matter and for this reason ISEMED is ready to support the Medical Device manufacturers, especially if they have to face different countries with their own relevant Regulatory Authorities. A deep knowledge of the technical subject as well as the regulations of each country or region is the basis for a quick and positive outcome of the approval process of a Medical Device, and especially a SaMD.
The only certainty regarding Medical Software, both embedded and stand-alone version, concerns the design and maintenance: the compliance with the IEC 62304 Medical device software — Software life cycle processes.
Regarding all these aspects, you can contact ISEMED and trust our collaboration!
About ISEMED Srl
Founded in 2008, ISEMED is a consulting company that helps Medical Devices and IVDs manufacturers in developing their business on the international market, considering all the mandatory steps in terms of time and cost effectiveness.
Through its international network and a continuous learning activity concerning Medical Devices, International Regulations and Technical Standards, ISEMED can support the industries to increase the technical, economic, commercial and regulatory business development in more than 140 countries in the world.
ISEMED is the only consulting company in medical field accredited by the Italian Economic Development Ministry (MISE) as Temporary Export Manager (code TEM_00000142).
Two kinds of software are related to medical devices: Embedded Software and Stand-Alone Software.
The first one is related to a medical electrical equipment, and it drives the performances, the user interface and the patients interaction, while the second one is related to an application running on general purposes computer systems, such as PCs, Servers, Apps in cloud or mobile systems.
The question about a software being a medical device or not concerns mainly the Stand-Alone software, because the embedded one is essentially a component of the whole electrical medical equipment.
The Stand-Alone Software can include several functions with different aims. Typically, this kind of software, used as IT system in a healthcare facility, can include administrative information as well as clinical data related to all patients, it is used by professionals to take their clinical decisions or to drive the performance of a medical device. For this reason, each module included into a software used in a medical centre, must be individually classified as medical device or not, according to its own indication for use. Thus, it is important to consider that, even if the software is used in a healthcare facility, this does not mean that it is a medical device.
Different criteria from competent Authorities can be found in relevant guidance documents. In October 2019, the EU MDCG group issued the MDCG 2019-11 guidance document, while the International Medical Device Regulatory Forum (IMDRF) published in December 2013 the guidance “Software as Medical Device (SaMD): Key Definitions”.
Both documents state that the criterion to qualify a software as a medical device must be related to the general definition of “medical device” as defined in the relevant regulations. But when the EU guidance states, for example, that a simple recording and retrieval of clinical data doesn’t qualify a software as medical device, other guidance instead considers it as SaMD because it influences a medical decision about the patient treatment.
As usual Medical Device Regulatory Affair is not a simple matter and for this reason ISEMED is ready to support the Medical Device manufacturers, especially if they have to face different countries with their own relevant Regulatory Authorities. A deep knowledge of the technical subject as well as the regulations of each country or region is the basis for a quick and positive outcome of the approval process of a Medical Device, and especially a SaMD.
The only certainty regarding Medical Software, both embedded and stand-alone version, concerns the design and maintenance: the compliance with the IEC 62304 Medical device software — Software life cycle processes.
Regarding all these aspects, you can contact ISEMED and trust our collaboration!
About ISEMED Srl
Founded in 2008, ISEMED is a consulting company that helps Medical Devices and IVDs manufacturers in developing their business on the international market, considering all the mandatory steps in terms of time and cost effectiveness.
Through its international network and a continuous learning activity concerning Medical Devices, International Regulations and Technical Standards, ISEMED can support the industries to increase the technical, economic, commercial and regulatory business development in more than 140 countries in the world.
ISEMED is the only consulting company in medical field accredited by the Italian Economic Development Ministry (MISE) as Temporary Export Manager (code TEM_00000142).
