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Evaluation ViewAttendees 36

Devices (includes Medical Devices and In Vitro Diagnostics)

Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)

Thursday, October 5, 2023
3:30 PM – 4:30 PM EDT
Location/Room: 510A
Intermediate Level
Article 23 of the MDR states that any part or component “that significantly changes the performance or safety characteristics …. of the device shall be considered to be a device”. But how does one define SIGNIFICANTLY in this case? For hardware products? For software and apps? No specific guidance is given on this subject at present. Can we define a defendable method using NBOG 2014-3 and/or MDCG 2020-3 and/or 60601 series (e.g. critical parts list) and/or EN 62304, or other documents? This session will review how we might do this, with some examples. Perspectives from industry (hardware, software, both) and a Notified Body will be given, including possible compliance implications of methods that might be attempted, for both legacy MDD products and MDR products.

Learning Objectives:

  • Learn approaches one might use to define SIGNIFICANT change to performance or safety for service and maintenance of medical devices and apps.
  • Thus define what changes can be made without notification to Regulators.
  • Understand the compliance implications of the various approaches one might take.