In Vitro Diagnostic Regulations (IVDR)

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 definition then outlines the principle or sole purpose of these devices. Under the IVDR, an IVD medical device must have a medical application or purpose. For more clarity on the definition of IVD medical devices, please refer to the IVDR (EU) 2017/746.

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 CE certification services for IVD medical devices under the EU IVDR and UKCA certification under the UK MDR (2002). Examples of products we cover include:

• Blood glucose monitors
• Cancer diagnostics
• Clinical chemistry assays
• Companion diagnostics
• Devices for blood grouping
• Devices for the detection of infectious agents
• Devices for human genetic testing
• Devices for tissue typing
• Immunoassays
• PCR assays including next generation sequencing panels
• Self-tests and near-patient testing devices

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 IVDR, if the in-vitro diagnostic medical device is class A (low risk) then “self-certification” is permitted unless it is placed on the market in a sterile condition. For any other classes, class B to D, involvement of a Notified

Body is necessary.

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