Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

General Safety and Performance Requirements

General Safety and Performance Requirements (Annex I)

... designed to ensure repeatability, reliability and performance in line with their intended use...

17 in MDR | 16 in IVDR

... developed and manufactured in accordance with the state of the art...

Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves

... in combinationwith mobile computingplatforms shall be designed and manufactured taking into account the specific features of the mobile platform... ... set out minimumrequirements concerning hardware, IT networks characteristicsand IT security measures, includingprotection againstunauthorised access, necessary to run the software as intended.

The Organisation for Professionals in Regulatory Affairs

21

Cybersecurity

Image from MDCG 2019-16 Guidance on Cybersecurity for medical devices

The Organisation for Professionals in Regulatory Affairs

22

11