2 docs tagged with "performance-evaluation"

The Essential Requirements specific to in vitro diagnostic medical devices under Schedule 1A of Part III of the UK Medical Devices Regulations 2002 — analytical performance, clinical performance, labelling, and instructions for use requirements.

Performance evaluation requirements for IVD medical devices under Part III of the UK MDR 2002 — analytical performance, clinical performance, scientific validity, and the Performance Evaluation Report (PER).