Module 14 2022
21/03/2022
Device material identification, chemical characterisation
• Same as in existing device? • Same chemical composition? • Manufacturing and sterilisation same? • Is body contact the same?
YES
Is there justification for risk assessment? NO
Conduct biological evaluation
The Organisation for Professionals in Regulatory Affairs
7
Is there justification for risk assessment?
• Do data exist for all chemicals in the material? • Do the data apply to chemical mixtures? • Are data relevant for dose and route of exposure?
NO
YES
Conduct biological evaluation
Perform further evaluation based on chemical nature of materials, type and duration of contact
The Organisation for Professionals in Regulatory Affairs
8
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