Regulatory Open Forum

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Hi Sravan,

Happy Holidays!

MDCG 2019-11 can be a good starting point (Sec 4.2.1 with explanation on Sub-rules 11a-c).

Additionally, there must be some medical benefit associated with the MDSW. 

Medical Device Software (MDSW)
Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a "medical device" in the medical devices regulation15 or in vitro diagnostic medical devices regulation.16
Software must have a medical purpose on its own to be qualified as a medical device software (MDSW). It should be noted that the intended purpose as described by the manufacturer of the software is relevant for the qualification and classification of any device.


Best regards,

------------------------------
AnaCiric
RA/QA Specialist
Singapore
------------------------------

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Hi,

rule #11 of the European Medical Device Regulation is heavily discussed.
Please follow the current interpretation of experts in social media:
https://www.linkedin.com/posts/stefan-bolleininger-3a717028_samd-class-1-options-and-limitations-after-activity-7011584551315472384-gdb1?utm_source=share&utm_medium=member_desktop

Best regards
Christian​

------------------------------
Christian Rosenzweig
Consultant
Marburg
Germany
------------------------------

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Sravan,
As Ana suggested, you should take a look at MDCG 2019-11 "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR". Section 4.2.1 (pages 13-14) classifies "Rule 11 – Software for decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes".  
Based on the description of intended uses, your SaMD device is likely a Class IIa. 

Best regards,



Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

I find the MDR with respect to MDSW very concerning and unfortunately per the MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR  the Class IIa category is an "everything else". 

I often wonder since the IEC 62304, "Medical Device Software - Software life cycle processes" is a harmonized standard adopted by both EU and the United States, why did the MDR comes up with another software classification against the Class A, B, and C per IEC 62304?

Best Regards
Ajit Basrur

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Thank you all for your expert views. As Ajit said if we go by MDCG 2019-11, Class IIa classification looks like a default classification for SaMDs (unless the for the high-risk claims). 

I am just thinking aloud, Is there any way we can coin the claims/indications and tone down the device functionality so that if would meet the definition of medical device but not fall in Class IIa bucket. This attempt is to reduce the financial burden (for NB) and a big notified body que for a small start-up which is trying to test the waters in EU. They can plan for full potential device under Class IIa at a later stage. 

From Christian Rosenzweig article, if we say, Software that calculates scores for the purpose of predicting the likelihood or progression of diseases XXXX which is not 'decisions with diagnosis or therapeutic purposes' & 'intended to monitor physiological processes'.

Appreciate your views and any alternative suggestions for indications statement. 

Thank you,
Sravan

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Original Message:
Sent: 24-Dec-2022 12:21
From: Ajit Basrur
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

I find the MDR with respect to MDSW very concerning and unfortunately per the MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR  the Class IIa category is an "everything else".

I often wonder since the IEC 62304, "Medical Device Software - Software life cycle processes" is a harmonized standard adopted by both EU and the United States, why did the MDR comes up with another software classification against the Class A, B, and C per IEC 62304?

Best Regards
Ajit Basrur

------------------------------
Ajit Basrur
Worcester MA
United States

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Hello Sravan,

this article should also interested you: https://www.johner-institut.de/blog/johner-institut/klasse-i-software/
(in German but Google translate is working pretty well on it)

BR,
Stephane.

------------------------------
Stephane Berger
La Ciotat
France
------------------------------

Original Message:
Sent: 28-Dec-2022 10:53
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Thank you all for your expert views. As Ajit said if we go by MDCG 2019-11, Class IIa classification looks like a default classification for SaMDs (unless the for the high-risk claims).

I am just thinking aloud, Is there any way we can coin the claims/indications and tone down the device functionality so that if would meet the definition of medical device but not fall in Class IIa bucket. This attempt is to reduce the financial burden (for NB) and a big notified body que for a small start-up which is trying to test the waters in EU. They can plan for full potential device under Class IIa at a later stage.

From Christian Rosenzweig article, if we say, Software that calculates scores for the purpose of predicting the likelihood or progression of diseases XXXX which is not 'decisions with diagnosis or therapeutic purposes' & 'intended to monitor physiological processes'.

Appreciate your views and any alternative suggestions for indications statement.

Thank you,
Sravan

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India

Original Message:
Sent: 24-Dec-2022 12:21
From: Ajit Basrur
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

I find the MDR with respect to MDSW very concerning and unfortunately per the MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR  the Class IIa category is an "everything else".

I often wonder since the IEC 62304, "Medical Device Software - Software life cycle processes" is a harmonized standard adopted by both EU and the United States, why did the MDR comes up with another software classification against the Class A, B, and C per IEC 62304?

Best Regards
Ajit Basrur

------------------------------
Ajit Basrur
Worcester MA
United States

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------

Hi Sravan
see this document, maybe help you.😊

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 22-Dec-2022 13:08
From: Sravan Kumar Manchikanti, RAC
Subject: How to place SaMD/MDSW as Class I device in EU? #Rule11

Hello Friends,

Happy Holidays!

I am supporting an AI based SaMD company for their CE mark.

The intended use of the device goes like this "The device is used as a screening tool and diagnostic aid in the assessment of respiratory conditions when used on adults (18 years of age and over) under the supervision of trained respiratory therapists or nurses. The device provides an informational report which is intended to be reviewed by a qualified healthcare practitioner (pulmonologist, general physician, and medical officers)."

Based on the intended use, my question is, which classification does this device fall into? Strategically, the company wants to go for a Class I as the device just provides an informational report to the physician.

I would request you to provide your expert opinion on this.

Thank you,

------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------