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This message was posted by a user wishing to remain anonymous

We are looking to place a Class II SaMD on the market in the US only.  We are trying to understand the differences in clinical evaluation requirements between the IMDRF N41 Clinical Evaluation and the EU MDR 2017/745.  We have a clinical evaluation process for our medical devices on the market in the EU and we are trying to assess if our EU process will satisfy IMDRF N41 or if that is setting a higher requirements bar than necessary.  The general concepts of clinical evaluation appear consistent between the documents but the IMDRF N41 does not appear to go to the detailed level that the EU MDR does.  Greatly appreciate any insight or guidance.

Hello Anon,

The regulatory pathway in the United States and European Union are completely different, especially in the area of clinical evaluation.  Also to clarify the IMDRF guidance you are referring would be WG/N41 (2017) Software as a Medical Device (SaMD): Clinical Evaluation.  While the IMDRF N41 is a "global guidance document" the use of this document in the United States regulatory pathway is not completely aligned.  First, there is no "clinical evaluation" file or similar for the U.S. 510(k) or PMA submission process.  The content, context, and information contained in IMDRF N41 is contained in other documents through the design control process and software documentation that would be contained in the U.S. premarket submission.  There are similarities between the EU MDR and IMDRF N41, because there is a Clinical Evaluation file existing in the European regulatory process which is used as part of the submission (Technical Documentation).  There is no similar document in the U.S. system, so the context of IMDRF N41 must be "extracted" through various parts of the company's documentation in order to provide information in the 510(k) (Class II) submission.  If you are planning to submit a Class II SaMD through a 510(k) process in the United States, your best guidance document to use would be the software submission guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions.  Then use the IMDRF guidance as a helpful document to understand some of the concepts.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Jul-2023 11:38
From: Anonymous Member
Subject: Clinical Evaluation Comparison of EU MDR and IMDRF N41 for SaMD

This message was posted by a user wishing to remain anonymous

We are looking to place a Class II SaMD on the market in the US only.  We are trying to understand the differences in clinical evaluation requirements between the IMDRF N41 Clinical Evaluation and the EU MDR 2017/745.  We have a clinical evaluation process for our medical devices on the market in the EU and we are trying to assess if our EU process will satisfy IMDRF N41 or if that is setting a higher requirements bar than necessary.  The general concepts of clinical evaluation appear consistent between the documents but the IMDRF N41 does not appear to go to the detailed level that the EU MDR does.  Greatly appreciate any insight or guidance.

Please see the FDA Guidance: Software as a Medical Device (SAMD): Clinical Evaluation - December 8, 2017. In this guidance FDA adopts the internationally converged principles agreed upon by the IMDRF.

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Kristen Kanack
Regulatory Sciences
Germantown, MD
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Original Message:
Sent: 12-Jul-2023 11:38
From: Anonymous Member
Subject: Clinical Evaluation Comparison of EU MDR and IMDRF N41 for SaMD

This message was posted by a user wishing to remain anonymous

We are looking to place a Class II SaMD on the market in the US only.  We are trying to understand the differences in clinical evaluation requirements between the IMDRF N41 Clinical Evaluation and the EU MDR 2017/745.  We have a clinical evaluation process for our medical devices on the market in the EU and we are trying to assess if our EU process will satisfy IMDRF N41 or if that is setting a higher requirements bar than necessary.  The general concepts of clinical evaluation appear consistent between the documents but the IMDRF N41 does not appear to go to the detailed level that the EU MDR does.  Greatly appreciate any insight or guidance.

This message was posted by a user wishing to remain anonymous

For a class II SaMD in US, the clinical evaluation report would be part of the software validation document in the big picture of "content of premarket submissions for device software functions", and would include content as per IMDRF N41 (scientific validity, analytical validation, clinical validation), plus addressing relevant special controls, FDA-recognised voluntary consensus standards, and device-specific guidances.

I agree with you that EU MDR (including MDCG 2020-1 guidance) follows the same approach of clinical evaluation as IMDRF N41, the former being published 2.5 years after the latter. I believe a clinical evaluation report compliant to EU MDR would also satisfy similar requirements for FDA (provided you address the relevant special controls etc. as mentioned above.)

Best regards,

Original Message:
Sent: 12-Jul-2023 11:38
From: Anonymous Member
Subject: Clinical Evaluation Comparison of EU MDR and IMDRF N41 for SaMD

This message was posted by a user wishing to remain anonymous

We are looking to place a Class II SaMD on the market in the US only.  We are trying to understand the differences in clinical evaluation requirements between the IMDRF N41 Clinical Evaluation and the EU MDR 2017/745.  We have a clinical evaluation process for our medical devices on the market in the EU and we are trying to assess if our EU process will satisfy IMDRF N41 or if that is setting a higher requirements bar than necessary.  The general concepts of clinical evaluation appear consistent between the documents but the IMDRF N41 does not appear to go to the detailed level that the EU MDR does.  Greatly appreciate any insight or guidance.

The FDA envisions reviewing the risk management for the device's intended use and the SaMD's clinical evaluation results (per the FDA guidance/IMDRF N41 document Software as a Medical Device (SaMD): Clinical Evaluation), as appropriate. FDA 510k doesn't have clinical evaluation as part of the device submission documentation , how ever we do use parts of clinical evaluation documentation for example, Clinical validation of a SaMD can also be viewed as the relationship between the verification and validation results of the SaMD algorithm and the clinical conditions of interest. Clinical validation is a necessary component of clinical evaluation for all SaMD and can be demonstrated by either:
 Referencing existing data from studies conducted for the same intended use;
 Referencing existing data from studies conducted for a different intended use, where
extrapolation of such data can be justified; or
 Generating new clinical data for a specific intended use

the above content is part for clinical evaluation as per MDR.

The quality and breadth of the clinical evaluation is determined by the role of the SaMD for the target clinical condition, and assures that the output of the SaMD is clinically valid and can be used reliably and predictably. 

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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
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Original Message:
Sent: 12-Jul-2023 11:38
From: Anonymous Member
Subject: Clinical Evaluation Comparison of EU MDR and IMDRF N41 for SaMD

This message was posted by a user wishing to remain anonymous

We are looking to place a Class II SaMD on the market in the US only.  We are trying to understand the differences in clinical evaluation requirements between the IMDRF N41 Clinical Evaluation and the EU MDR 2017/745.  We have a clinical evaluation process for our medical devices on the market in the EU and we are trying to assess if our EU process will satisfy IMDRF N41 or if that is setting a higher requirements bar than necessary.  The general concepts of clinical evaluation appear consistent between the documents but the IMDRF N41 does not appear to go to the detailed level that the EU MDR does.  Greatly appreciate any insight or guidance.