Module 14 2022
22/03/2022
Exemption
Custom-made devices
•
• Devices for Clinical Investigation
NO UKCA Mark should be provided
Devices for Performance Evaluation
•
• Non-compliant goods used in exceptional circumstances
The Organisation for Professionals in Regulatory Affairs
Diverging approaches to MD requirements – EEA and UK
13
Summary
The Organisation for Professionals in Regulatory Affairs
Diverging approaches to MD requirements – EEA and UK
14
7
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