If you are willing to certify your SaMD – Software as a Medical Device, Maven is all prepped to guide you!
So where did this term come from?
Well, nowadays technology is making its way into everybody’s lives. Even healthcare sector has not been left out. Software has become a part of many medical devices and in some cases, software, which on its own is a medical device.
The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being a part of a hardware medical device.”
Now you might already know that as per EU MDR – 2017/745, for Software as a Medical Device – SaMD, there is a provision of a specific rule –
“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I.”
Below are the definitions that are provided in MDCG guideline document – “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” released in October 2019 –
“Software driving or influencing the use of a device Software which is intended to drive or influence the use of a (hardware) medical device and does not have or perform a medical purpose on its own, nor does it create information on its own for one or more of the medical purposes described in the definition of a medical device or an in vitro diagnostic medical device. This software can, but is not limited to: (a) operate, modify the state of, or control the device either through an interface (e.g., software, hardware) or via the operator of this device (b) or supply output related to the (hardware) functioning of that device
Note: Software driving or influencing the use of a (hardware) medical device may be qualified as an accessory for a (hardware) medical device.”
Let us enlighten you with few examples of Software as a Medical Device – SaMD :
Now let us take a look at a few examples of Software driving or influencing the use of a device –
Also, Software may be qualified as MDSW regardless of its location (Like operating in cloud, on computer, on mobile phone, or an additional functionally on a hardware medical device)
And, Software that is intended to be used by healthcare professionals or lay persons (e.g. patients or other users)
Now to get your CE Certificates for Medical Device Software, we have laid out the complete pathway of this regulatory process for you –
1st step would be to reveiw your Medical Device Software and classify it as per the Classification rules provided in EU MDR 2017/745
Next step would be to establish QMS of the organization (Note - Class I Device - Not mandatory)
Now let's draft the Technical File as per the Annnex II and III of EU MDR
Time to appoint the Authorized Representative and do not forget to get the agreement signed from them (As per Article 11 of EU MDR).
Have you registered your company on EUDAMED Portal yet ? No? Go for it ! Do register your devices as well once the modules gets active !
Class I MDSW? - Self declare the CE Mark otherr Class ? - get your TCF & QMS audited by the Notified Body
Notified Body : Here is your CE Certificate ! Now you can affix CE mark on the Medical Device
Classification of the medical device software does not affect the patient directly. Hence, it relates mainly to the indirect harms from the failures.
So EU Regulation gave us an amazing solution by adding one separate rule (Rule 11) for medical device software and to address the risks related to the information provided by the Active Devices.
Allow us to explain that “Software is also defined as an Active Medical Device”
“Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I.”
Annexure III of the MDCG 2019-11 guideline document has also provided the Risk Classification Framework for the Medical Device Software with the guidance of Rule No. 11 specified in the EU MDR Regulation –
| Significance of Information provided by the MDSW to a healthcare situat related to diagnosis/therapy | ||||
|---|---|---|---|---|
| State of healthcare situation of patient condition | High(Treat/Diagnose) | Medium(Drives Clinical Management ) | Low(Informs Clinical Management ) | |
| CriticalSituation/patient condition | Class III | Class IIb | Class IIa | |
| SeriousSituation/patient condition | Class IIb | Class IIa | Class IIa | |
| Non-SeriousSituation/patient condition | Class IIa | Class IIa | Class IIa | |
Why fear? Maven is here!
We have a specialized team of talented and trained technical experts take care of the requirements of the Medical Device Software Technical File Submission and the end-to-end CE marking process for your Medical Device Software (MDSW).
All the necessary actions related to the complete CE marking process like –
Not sure about whether your software can be called Medical Device Software or not?
Put your worry aside and go through below examples to get the idea for your Medical Device Software!
System that supports the process of patient management
(Patient admission/appointments/insurance/billing)
Systems
(Intended for ambulance services & transfer information from patients to a doctor)
Systems
(Intended for ambulance services & transfer information from patients to a doctor)
(E.g. email systems, mobile telecommunication systems, video communication systems, paging, etc. to transfer electronic information. Messages are sent such as prescription, referrals, images, patient records, etc.)
(Modules that are intended to perform administrative monitoring of non-medical performance of medical devices)
