Module 14 2022

22/03/2022

IMDRF guidance 2019 ● Product name, address of manufacturer ● Intended purpose and intended user ● Performance intended by the manufacturer ● Residual risks (contraindications, warnings etc) ● Specifications required to use the device – (the expected degree of accuracy) http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-pl-md-ivd.pdf Start to prepare your initial IFU (1) .. and design aspects..

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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Start to prepare your initial IFU (2) ..and design aspects..

● Identification of any medicinal substances / items of biological origin ● Details on preparatory treatment or handling required before it can be used (e.g. sterilisation). ● Training requirements for user ● How to verify if the device has been installed / set up properly – Maintenance requirements – Consumable components – Calibration requirements – Methods for eliminating risks encountered when installing, calibrating or servicing the device. ● Special storage / handling requirements

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

28

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