2. The European in Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

The European in Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

The IVDR is the new regulation for a specific category of Medical Devices [1] and lays down the rules concerning the placing in the market, making available on the market or putting into service of in vitro diagnostic Medical Devices for human use and accessories for such devices in the European Union. This Regulation also applies to performance studies concerning such in vitro diagnostic Medical Devices and accessories in the European Union. One of the main changes of the IVDR as compared to the former IVD directive from 1998, is that it will subject more diagnostic tests to Notified Bodies oversight. It will also tighten the clinical evidence rules pursuant to these tests, just as it tightens the rules for tests that laboratories may make ‘in-house’ for their own use.

Article 2 of the regulation defines IVDs as follows:

‘in vitro’ diagnostic Medical Device’ means 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, solely or principally for the purpose of providing information on one or more of the following:

• Concerning a physiological or pathological process or state.
• Concerning congenital physical or mental impairments.
• Concerning predisposition to a medical condition or a disease.
• To determine the safety and compatibility with potential recipients.
• To predict treatment response or reactions.
• To define or monitor therapeutic measures.

It should be noted that even if something is not an in vitro Medical Device, it can still be a Medical Device and fall under the Medical Device regulation. In addition, different countries outside of the EU and US may use different definitions for Medical Devices. It is thus always recommended to check the local definition.