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CE for Medical Device Software – SaMD

SaMD – Software as a Medical Device

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 –

Rule No. 11

“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:

  • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
  • a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

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.”

But do not get confused between Software as a Medical Device & Software driving or influencing the use of a medical device!

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 :

  • Imaging Software to detect tumours
  • Software that detects Myocardial Infarction
  • information from trend reporting;
  • Software used for EEG Analysis
  • Software that receives measurements from transrectal ultrasound findings, age

Now let us take a look at a few examples of Software driving or influencing the use of a device –

  • Software intended to measure & transmit blood glucose levels, calculate insulin dose required
  • Melanoma image analysis software intended to drive a near – infrared laser light scanner

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)

  • Software that is intended to operate a point of care test from a remote location

And, Software that is intended to be used by healthcare professionals or lay persons (e.g. patients or other users)

  • Software that provides insulin dose recommendations to a patient regardless of the method of delivery of the prescribed dose, whether via an insulin pump, insulin pen or insulin syringe.

CE CERIFICATION FOR MEDICAL DEVICE SOFTWARE PROCESS

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

MEDICAL DEVICE SOFTWARE – SaMD CLASSIFICATION AS PER EU MDR (2017/745) REGULATION

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”

RULE NO. 11

“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.”

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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 conditionHigh(Treat/Diagnose)Medium(Drives Clinical Management )Low(Informs Clinical Management )
CriticalSituation/patient conditionClass IIIClass IIbClass IIa
SeriousSituation/patient conditionClass IIbClass IIaClass IIa
Non-SeriousSituation/patient conditionClass IIaClass IIaClass IIa

HOW MAVEN CAN HELP WITH MDR SOFTWARE CE MARKING?

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 –

  • Classifying your Medical Device Software as per the Classification Rules mentioned in the EU MDR (2017/745) regulation
  • Already have the existing QMS? If yes, then updating the QMS as per the requirements available in the EU MDR regulation & If not, establishment of the complete QMS set
  • Guidance on the technical documentation preparation including all necessary requirements like Software Risk Management, Software Validation, Post market activities, Clinical evaluation etc.
  • Constant support from submission of technical file to Notified Body to responding to the queries raised by the Technical File Reviewer.
  • Audit support for the initial audits as well as surveillance audit until the validity of the CE certificate to help you out with the queries raised by the auditor for smooth auditing process.

GLIMPSE OF THE SOFTWARE WHICH ARE NOT MDSW

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!

  • Hospital Information System
  • Other Information systems

System that supports the process of patient management

(Patient admission/appointments/insurance/billing)

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Systems

(Intended for ambulance services & transfer information from patients to a doctor)

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Systems

(Intended for ambulance services & transfer information from patients to a doctor)

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(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)

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