What is an IVD medical device?

As a manufacturer of an in vitro diagnostic (IVD) medical device, you must ensure you meet the relevant requirements outlined in the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

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 IVDR. 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

Key resources to support you with IVD

Stay up to date with the latest updates from BSI