NA 022

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Project

Machine learning-enabled medical device - Performance evaluation process

Abstract

This document defines a standardized performance evaluation process for Machine Learning-enabled Medical Devices (MLMD). The set of processes, activities, and tasks described in this document establishes a common framework for MLMD performance evaluation processes.

Begin

2025-05-27

Planned document number

DIN EN IEC 63521

Project number

02233170

Responsible national committee

DKE/UK 811.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

Contact

Dorina Laurila-Epe

Merianstr. 28
63069 Offenbach am Main

Tel.: +49 69 6308-295

Send message to contact