Document published by the source itself
In vitro diagnostic medical devices: guidance on legislation
What Great Britain actually requires of IVD sale and supply, under Part IV of UK MDR 2002.
Source
This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices in Great Britain and explains the main features of the requirements for IVDs, set out in Part IV of the UK Medical Devices Regulations 2002 (as amended) (UK MDR 2002).
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Key takeaways
What Great Britain actually requires of IVD sale and supply, under Part IV of UK MDR 2002.
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-09
2026-10-09
professional use
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