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  • Medical Devices
    Technical Team

In vitro diagnostic medical devices

Placing your In Vitro Diagnostic Medical Devices on the market

As an IVD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market.

It is critical to work with a trusted EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

We truly understand the challenges that medical devices manufacturers face bringing compliant IVDs on to market efficiently and safely. Whether you're starting the certification process or looking to transfer to BSI, we offer a range of flexible product review services providing you with efficient pathways to bring your device to 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.

When a change in your IVD can be deemed significant?

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 of the device after the IVDR date of application.

  • No significant changes in the device's intended purpose after the IVDR date of application.

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

  • In case of significant changes in the device's intended purpose, a new IVDR application is required.

  • For additional guidance on this concept, please see the document linked below.

    MDCG 2022-6
Our Experts

Meet our experts

Our IVD team has a broad range of industry experience, including product design and development, manufacturing, testing and regulatory expertise.

  • Our Experts

    Dr Elizabeth Harrison, Global Head of IVD, BSI

    "We know that IVDs come in all shapes and sizes and that navigating this highly regulated industry is challenging for many manufacturers."

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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