Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Medical Device Software

Observations (MDCG 2023-4)

Classification

Software

Hardware

The hardware or hardware component is an integral part of a general consumer product or an accessory to MD and has no intended purpose, where the software manufacturer must comply with requirements concerning system or procedure pack (article 22 MDR) as a combination with another MD/IVD or as integral part of a MD/IVD. The hardware or hardware component is placed on the market as a medical device either as part of a system,

receives and processes data from

Software and Hardware classify on its own

PROCESS

Hardware that is not MD/IVD

Software

Software classify on its own

receives and processes data from

PROCESS

Be aware to avoid off label use of the IVD!

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General Safety and Performance Requirements

Devices needs to meet

23 GSPRS • Chapter I: General Requirements • Chapter II: Requirements regarding design and manufacture • Chapter III: Requirements regarding the information supplied with the device

General Safety and Performance Requirements

A comprehensive list of requirements to ensure

Device Safety

Device Performance

To meet these requirements, applicable (harmonized) standards shall be used

ISO 14971 Risk Management

IEC 62304 Software Lifecycle

ISO 13485 QMS

IEC 62366-1 Usability

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