Placing your In Vitro Diagnostic Medical Device on the market

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 information on regulatory requirements consult:

• Europe - In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
• UK - Medical Devices Regulations (UK MDR) 2002

For additional information on legislations regulating IVDs and transition timelines, visit our IVDR, CE marking and UKCA marking dedicated webpages.

The transitional provisions in Article 110(3) IVDR, as amended by Regulation (EU) 2022/112 apply under the conditions that:

• Devices continue to comply with the IVDD
• There are no significant changes in the design or intended purpose of the device after the IVDR date of application

In case of significant changes in the design or intended purpose of the device, a new IVDR application is required.

For additional guidance on the concept of significant changes in the design and intended purpose under Article 110(3) IVDR, see MDCG 2022-6.