IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device

Recommendation

7/8 May 2024

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The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). The objective of this organisation is to drive harmonisations within the medical device world. Australia, Brazil, Canada, China, Russia and Singapore are also members of this organisation beside the Triad (Europe, USA and Japan).  

Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation". The topic "software" is being intensively discussed in the medical device area. On 46 pages in total, the IMDRF has laid down requirements for clinical evaluation with software. 6 pages at the end of the document are dedicated to examples of clinical evaluation concepts.

The objective of the document is to:

• describe relevant clinical evaluation methods which can be used for clinical evidence of software as a medical device.
• describe the required level of clinical evidence for different categories of software as a medical device.
• describe categories of software as medical device where independent review can be important or not important.

The FDA has adopted the IMDRF draft. Insofar, the document can also be found on the FDA website.