IVD medical device classification under Part III of the UK Medical Devices Regulations 2002 — Annex II List A, Annex II List B, self-test devices, and general IVDs, with conformity assessment requirements for each category and comparison with EU IVDR Class A–D.
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).
The legal definition of an in vitro diagnostic medical device (IVD) under Part III of the UK Medical Devices Regulations 2002, IVD classification categories, and how IVD regulation differs from general medical devices.