Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Biological Assessment/Nonclinical Assessment

• Biocompatability Assessment 

Device

Toxicology Assessment 

Device/Drug

•

Biological Safety 

Device/Drug

•

Microbiological Safety X

•

Clinical Effects X

•

The Organisation for Professionals in Regulatory Affairs

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Guidelines – Medical Device

ISO 10993 - Biological evaluation of medical devices

• Published 2018, preparation of new version is ongoing, to be replaced by ISO/CD 10993-1.2

• Provides guidance on how to perform biological evaluation of a device

• Describes a matrix of toxicity endpoints that should be considered

Out of scope • Hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens

•

The Organisation for Professionals in Regulatory Affairs

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