In Vitro Diagnostic Medical Devices

In Vitro Diagnostic Medical Devices

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In Vitro Diagnostic Medical Devices
In Vitro Diagnostic Medical Devices
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Placing your In Vitro Diagnostic Medical Device 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.

  • Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Regulations.
  • Approved Body - BSI UK (0086) - provides conformity assessments under the UKCA Scheme.

We truly understand the challenges that medical devices manufacturers face bringing compliant products 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 product to market.

MDR QMS deadline 2023

Time for your IVDR application is now

"If you do not have an agreement with a Notified Body reach out today and if your technical documentation is ready, there is really no reason to delay your IVDR application".

Elizabeth (Liz) Harrison, Global Head of IVD at BSI.

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IVDR Class D Requirements in the Absence of EU Reference Laboratories

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 information on regulatory requirements consult:

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

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 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.

Dr Elizabeth Harrison

Meet our experts

As a manufacturer of IVD medical devices, one of your biggest challenges in breaking into, or continuing your success in, this market is navigating the regulatory process efficiently. Strong, statistically relevant clinical data demonstrating the safety and performance of your device is essential to ensuring a successful outcome of your IVDR application.

Our IVD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise. They will support you through the process of certifying your device.

Explore our IVD brochure

Explore our IVD brochure

Download our IVD brochure to learn more about how we can support your product launch.

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First IVDR Annex IX Chapter II Class D Certificate issued

First IVDR Annex IX Chapter II Class D Certificate issued

BSI IVDR Notified Body issued its first IVDR Annex IX Chapter II Class D certificate on 11 January 2023.

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IVDR

BSI statement on conformity assessment for class D devices under the IVD Regulation

BSI would like to draw your attention to an important update regarding notified body activity for Class D IVDs under the In Vitro Diagnostic Regulation (IVDR) EU 2017/746.

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