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
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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
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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,
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Sravan Kumar Manchikanti, RAC
Hyderabad
India
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