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.

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

Training medical devices

Training courses

We offer training tailored to the In Vitro Diagnostic Regulation to help support and grow your business.

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