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  • Medical Devices
    Technical Team

Medicinal and Biologics Medical Devices

Placing your devices on the market.

As a manufacturer you must ensure that your device meets the relevant regulatory requirements before being placed on the market

It is critical to work with an 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.

Our Medicinal & Biologics team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise. With more than 200 years of overall combined experience, our team provides guidance on ancillary medicinal substances and blood derivative devices, as well as conformity assessments for MDR (Rule 18) and UK MDR 2002, Part II (MD) (Rule 17) for medical devices utilizing non-viable tissues of animal origin and for those utilizing tissues or cells of human origin and their derivates.

BSI Medicinal and Biologics team also offers expertise on ARTI/IVF legacy devices and emerging technologies related to medicinal, animal origin and biological substances.

Additional resources to support you

  • The safety and performance requirements of medical devices in the European market.

    Find out more
  • Nanomaterials and nanotechnology in medical devices.

    Read more
  • A wide range of free and live webinars.

    Medical Device
Our Experts

Meet our experts

Our Medicinal & Biologics team have broad industry & regulatory experience, including product design & development, manufacturing and testing.

Our Experts

Theresa Jeary, Global Head of Medicinal and Biologics, BSI

"Experienced in MDR Conformity Assessment spanning MDR Rules 14, 18 & 21, ART/IVF & organ preservation devices. NB of choice for MDR Article 117 NBO."

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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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