What is an IVD medical device?
An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”
The in vitro diagnostic (IVD) medical devices in the UK are regulated by the UK Medical Devices Regulations 2002 (as amended)(UK MDR 2002). Part IV of the UK MDR outlines the current controls on the sale and supply of in vitro diagnostics in the GB. Part IV must be read in conjunction with the MHRA Guidance as well as the vigilance guidance for IVDs and advice of UK Approved Bodies on self-tests.
Our IVD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer certification services for IVD medical devices under the EU IVDR and UKCA certification under the UK MDR (2002). Examples of products we cover include:
Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
Under UK MDR, general IVD devices (i.e. all devices other than devices for self-testing or devices appearing in Annex II) can be “self-certified”. The majority of IVDs do not require the intervention of a UK approved body in the conformity assessment process. However, for some IVDs (the correct performance of which is perceived to be essential to health), involvement of a UK approved body will be required.
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